Search

Study Objective: Several simulation models have been evaluated for gynecologic procedures such as hysterectomy, but there are limited published data for myomectomy. This study aimed to assess the validity of a low-cost robotic myomectomy model for surgical simulation training., Design: Prospective cohort simulation study., Setting: Surgical simulation laboratory., Participants: Twelve obstetrics and gynecology residents and 4 fellowship-trained minimally invasive gynecologic surgeons were recruited for a 3:1 novice-to-expert ratio., Interventions: A robotic myomectomy simulation model was constructed using <$5 worth of materials: a foam cylinder, felt, a stress ball, bandage wrap, and multipurpose sealing wrap. Participants performed a simulation task involving 2 steps: fibroid enucleation and hysterotomy repair. Video-recorded performances were timed and scored by 2 blinded reviewers using the validated Global Evaluative Assessment of Robotic Skills (GEARS) scale (5-25 points) and a modified GEARS scale (5-40 points), which adds 3 novel domains specific to robotic myomectomy. Performance was also scored using predefined task errors. Participants completed a post-task questionnaire assessing the model's realism and utility., Measurements and Main Results: Median task completion time was shorter for experts than novices (9.7 vs 24.6 min, p = .001). Experts scored higher than novices on both the GEARS scale (median 23 vs 12, p = .004) and modified GEARS scale (36 vs 20, p = .004). Experts made fewer task errors than novices (median 15.5 vs 37.5, p = .034). For interrater reliability of scoring, the intraclass correlation coefficient was calculated to be 0.91 for the GEARS assessment, 0.93 for the modified GEARS assessment, and 0.60 for task errors. Using the contrasting groups method, the passing mark for the simulation task was set to a minimum modified GEARS score of 28 and a maximum of 28 errors. Most participants agreed that the model was realistic (62.5%) and useful for training (93.8%)., Conclusion: We have demonstrated evidence supporting the validity of a low-cost robotic myomectomy model. This simulation model and the performance assessments developed in this study provide further educational tools for robotic myomectomy training., (Copyright © 2024 AAGL. Published by Elsevier Inc. All rights reserved.)

Study Objective: The purpose of this study is to review the trends in racial and gender representation among the various national obstetrics and gynecology societies' presidents over the past 15 years., Design: A retrospective cross-sectional study., Setting: Data obtained from publicly available information on official websites of the professional societies studied., Patients: Presidents of national societies in obstetrics and gynecology., Interventions: The study was performed by obtaining publicly available data for past presidents from the official websites of the professional societies studied. Gender and race were inferred based on name and image. Racial classification was selected using the United States Census classification system. Educational background, residency training, and practice type were also collected. Assessment of 15-year trends was completed using linear regression analysis and differences in representation was assessed using analysis of variance and post hoc analysis., Measurements and Main Results: Over 15 years, there were 134 presidents elected for the 10 obstetrics and gynecology societies. Of those leaders, 85.2% were white, 8.2% Asian, and 5.2% black; 59% were men and 41% were women. During the study period, there was a significantly increasing slope for representation of women (+2.3% per year; 95% confidence interval, 0.4-4.2; p = .016). The representation of nonwhite presidents (+1.5% per year; 95% confidence interval, 0.2-2.8; p = .028) increased significantly during the same time period., Conclusion: Over the last 15 years, less than 50% of obstetrics and gynecology national societies' presidents were women and most were of white race. However, there has been an increasing trend in the ratio of women to men and nonwhite to white representation among presidents of obstetrics and gynecology national societies., (Copyright © 2023 AAGL. Published by Elsevier Inc. All rights reserved.)

Introduction and Hypothesis: The objective was to study the effect of immediate pre-operative warm-up using virtual reality simulation on intraoperative robot-assisted laparoscopic hysterectomy (RALH) performance by gynecology trainees (residents and fellows)., Methods: We randomized the first, non-emergent RALH of the day that involved trainees warming up or not warming up. For cases assigned to warm-up, trainees performed a set of exercises on the da Vinci Skills Simulator immediately before the procedure. The supervising attending surgeon, who was not informed whether or not the trainee was assigned to warm-up, assessed the trainee's performance using the Objective Structured Assessment for Technical Skill (OSATS) and the Global Evaluative Assessment of Robotic Skills (GEARS) immediately after each surgery., Results: We randomized 66 cases and analyzed 58 cases (30 warm-up, 28 no warm-up), which involved 21 trainees. Attending surgeons rated trainees similarly irrespective of warm-up randomization with mean (SD) OSATS composite scores of 22.6 (4.3; warm-up) vs 21.8 (3.4; no warm-up) and mean GEARS composite scores of 19.2 (3.8; warm-up) vs 18.8 (3.1; no warm-up). The difference in composite scores between warm-up and no warm-up was 0.34 (95% CI: -1.44, 2.13), and 0.34 (95% CI: -1.22, 1.90) for OSATS and GEARS respectively. Also, we did not observe any significant differences in each of the component/subscale scores within OSATS and GEARS between cases assigned to warm-up and no warm-up., Conclusion: Performing a brief virtual reality-based warm-up before RALH did not significantly improve the intraoperative performance of the trainees., (© 2023. The International Urogynecological Association.)

Background: The American College of Obstetricians and Gynecologists released Committee Opinion No. 736: Optimizing Postpartum Care (CO No. 736) to address severe maternal morbidity and mortality in the United States by outlining recommendations for care in the critical time following birth. This study aimed to evaluate implementation of and barriers to the recommendations of CO No. 736 among obstetricians in south Louisiana. Methods: A survey to general obstetric providers assessed opinions on the CO No. 736 recommendations, implementation of these recommendations, and barriers to implementation. Fisher exact test was used to compare distributions between resident and attending groups. Qualitative, free-text responses about barriers to implementation were organized by common themes and categorized into systemic and patient factors. Results: Of 124 survey responses, 59.7% of respondents reported that they had read CO No. 736. Of the respondents who had read the document, 86.5% believed it was important to implement these recommendations, but only 50.0% had established the recommendations in their practices. Overall, fewer than half (46.8%) of respondents reported actively implementing the recommendation to make contact with postpartum patients at 3 weeks or sooner, but 86.3% reported having comprehensive clinic visits within 12 weeks of delivery. Commonly identified systemic barriers to implementation included the 3-week contact not being common practice, overbooked schedules, and unclear provider expectations. Commonly identified patient factor barriers to implementation included childcare or transportation and no-shows at postpartum appointments. Conclusion: Both resident and attending obstetricians in South Louisiana believe that the CO No. 736 recommendations are important but reported lacking the ability to implement them into clinical practice., (©2023 by the author(s); Creative Commons Attribution License (CC BY).)

Background: Enhanced recovery after surgery (ERAS) protocols improve outcomes. We investigated ERAS implementation in a population with comorbid conditions, inadequate insurance, and barriers to healthcare undergoing gynecologic surgery., Objective: To investigate ERAS implementation in publicly insured/uninsured patients undergoing gynecologic surgery on hospital length of stay (LOS), 30-day hospital readmission rates, opioid administration, and pain scores., Study Design: Data were obtained pre- and post-ERAS implementation. Patients undergoing gynecologic surgery with private insurance, public insurance, and uninsured were included (N = 589). LOS, readmission <30 days, opioid administration, and pain scores were assessed., Results: Implementation of ERAS led to shorter LOS 1.75 vs. 1.49 days (p = 0.008). Average pain scores decreased from 3.07 pre-ERAS vs. 2.47 post-ERAS (p = <0.001). Opioid use decreased for ERAS patients (67.22 vs. 33.18, p = <0.001). Hospital readmission rates were unchanged from 8.2% pre-ERAS vs. 10.3% post-ERAS (p = 0.392)., Conclusions: ERAS decreased pain scores and opioid use without increasing LOS or readmissions., Competing Interests: Declaration of competing interest Dr. Jernigan reports personal fees from AstraZeneca. The remaining authors have no conflicts of interest to disclose. The requirement for informed consent was waived for this study. IRB approval was obtained from the LSU and Tulane IRBs., (Copyright © 2022. Published by Elsevier Ltd.)

Background: Simulation is an important adjunct to traditional surgical training, allowing for repetitive practice of new skills without compromising patient safety. Although several simulation models have been described and evaluated for gynecologic procedures, there is a lack of such models for laparoscopic myomectomy., Objective: This study aimed to design a low-cost, low-fidelity laparoscopic myomectomy simulation model and to assess the model's validity as a training tool., Study Design: The model was constructed using a "cup turner" foam cylinder, felt, a 2-inch stress ball, self-adhesive bandage wrap, multipurpose sealing wrap, red marker, and hook-and-loop fastener. Participants were recruited at a quaternary care academic center and at the Society for Gynecologic Surgeons Annual Scientific Meeting. The simulation task involved the following 2 steps: fibroid enucleation and hysterotomy repair. Validity evidence was collected by comparing expert and novice simulation task performances. Video recordings were scored by 2 blinded reviewers using the Global Operative Assessment of Laparoscopic Skills scale (5-20 points) and a modified Global Operative Assessment of Laparoscopic Skills scale (5-35 points), incorporating 3 novel domains specific to laparoscopic myomectomy. The Mann-Whitney U test was used to compare the task completion times and performance scores. Interrater reliability of scoring was assessed using the interclass correlation coefficient. Validity was also assessed with a post-task survey regarding the model's realism, utility, and educational effect., Results: The total cost to construct each model was under $5. A 3:1 ratio was used to recruit 15 novices and 5 experts. The median time to task completion was shorter for experts than for novices (11.8 vs 20.1 minutes; P=.004). The experts scored higher than the novices on both the Global Operative Assessment of Laparoscopic Skills scale (median 19 [range 13-20] vs 10 [6-17.5]; P=.007) and the modified Global Operative Assessment of Laparoscopic Skills scale (31.5 [21.5-33.5] vs 18.5 [13.5-32]; P=.009). The interclass correlation coefficient was 0.95 for the Global Operative Assessment of Laparoscopic Skills scores and 0.96 for the modified Global Operative Assessment of Laparoscopic Skills scores. Most of the participants agreed that the model closely approximated the feel of fibroid enucleation (70% [14/20]) and suturing the uterus (80% [16/20]). All the participants agreed that the model was useful for learning or teaching laparoscopic myomectomy., Conclusion: This study demonstrates evidence supporting the validity of a novel, low-cost laparoscopic myomectomy model and a novel assessment scale for laparoscopic myomectomy training. This simulation model provides a targeted training tool that allows learners to focus on the key aspects of laparoscopic myomectomy and may improve readiness for the operating room., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Enhanced recovery after surgery (ERAS), or "fast-track" protocol, aims to minimize the physiologic stress of surgery and optimize the rehabilitation of patients. However, there is limited data in obstetrics and gynecology. We reviewed the published literature on ERAS programs in gynecology to evaluate the outcomes and potential key elements for a successful program. Fifty studies were evaluated. We recommend preoperative counseling to the patient, no bowel preparation, an opioid-sparing multimodal approach to pain management, goal-directed fluid management, minimally invasive surgery when possible, and early mobilization and feeding. This is a multidisciplinary team effort and requires active patient participation in the process., (Copyright © 2019. Published by Elsevier Inc.)

Study Objective: To demonstrate a laparoendoscopic single-site (LESS) surgical approach to salpingectomy., Design: A technical video showing step-by-step a LESS surgical approach to salpingectomy (Canadian Task Force classification level III). Institutional review board approval was not required for this study., Setting: Of all gynecologic cancer types, ovarian cancer has the highest mortality rate and is the fifth leading cause of cancer deaths among women [1,2]. The leading theory of epithelial ovarian carcinogenesis indicates that serous, endometrioid, and clear cell ovarian carcinomas originated from the fallopian tube and endometrium and not directly from the ovary itself [1-10]. This has led to the use of prophylactic salpingectomy as a theoretical form of ovarian cancer risk reduction at the time of hysterectomy or as a means of tubal sterilization. Prophylactic salpingectomy does not appear to increase the risk of complications and appears to be safe [2]. Ovarian function does not seem to be compromised by salpingectomy based on serum markers or response rates with in vitro fertilization [11-16]. A LESS approach may reduce the morbidity associated with the placement of multiple ports and can improve cosmetic outcomes. Prophylactic LESS bilateral salpingo-oohorectomy was shown to be feasible and safe for high-risk patients for ovarian cancer [17]., Interventions: Laparoscopic salpingectomy at the time of hysterectomy or as a means of tubal sterilization using the LESS technique., Conclusion: This is a simple and reproducible technique for preventing major complications associated with LESS salpingectomy. This approach permits easier specimen retrieval because of the large solitary incision that is made. There is a significant improvement in cosmetic satisfaction when compared with a traditional laparoscopic approach in the setting of prophylactic risk reduction surgery [18]., (Copyright © 2017. Published by Elsevier Inc.)

Operative cost and outcomes between robotic and laparoscopic hysterectomy across different uterine weights. Retrospective cohort study including patients undergoing robotic and laparoscopic hysterectomy for benign disease at an Academic university hospital. One hundred and ninety six hysterectomies were identified (101 robotic versus 95 laparoscopic). Demographic and surgical characteristics were statistically equivalent. Robotic group had a higher body mass index (±SD) (32.9 ± 6.5 versus 30.4 ± 7.1, p 0.012) and more frequent history of adnexal surgery (12.9 versus 4.2%, p 0.031). Laparoscopic group had a higher number of concurrent salpingectomy (81 versus 66.3%, p 0.02). Estimated blood loss did not differ between procedures. Compared to robotic hysterectomies, laparoscopic procedures added 47 min (CI: 31-63 min; p < 0.001) of operative time, costed $1648 more (CI: 500-2797; p = 0. 005) and had triple the odds of having an overnight admission (OR = 2.94 CI: 1.34-6.44; p = 0.007). After stratification of cases by uterine weight, the mean operative time difference between the two groups in uteri between 750 and 1000 g and in uteri >1000 g was 81.3 min (CI: 51.3-111.3, p < 0.0001) and 70 min (CI: 26-114, p < 0.005), respectively, in favor of the robotic group. Mean direct cost difference in uteri between 750 and 1000 g and uteri >1000 g was 1859$ (CI: 629-3090, p < 0.006) and 4509$ (CI: 377-8641, p < 0.004), respectively, also in favor of the robotic group. In expert hands, robotic hysterectomy for uteri weighing more than 750 g may be associated with shorter operative time and improved cost profile.

Purpose of Review: The negative impact of postoperative adhesions has long been recognized, but available options for prevention remain limited. Minimally invasive surgery is associated with decreased adhesion formation due to meticulous dissection with gentile tissue handling, improved hemostasis, and limiting exposure to reactive foreign material; however, there is conflicting evidence on the clinical significance of adhesion-related disease when compared to open surgery. Laparoscopic surgery does not guarantee the prevention of adhesions because longer operative times and high insufflation pressure can promote adhesion formation. Adhesion barriers have been available since the 1980s, but uptake among surgeons remains low and there is no clear evidence that they reduce clinically significant outcomes such as chronic pain or infertility. In this article, we review the ongoing magnitude of adhesion-related complications in gynecologic surgery, currently available interventions and new research toward more effective adhesion prevention., Recent Findings: Recent literature provides updated epidemiologic data and estimates of healthcare costs associated with adhesion-related complications. There have been important advances in our understanding of normal peritoneal healing and the pathophysiology of adhesions. Adhesion barriers continue to be tested for safety and effectiveness and new agents have shown promise in clinical studies. Finally, there are many experimental studies of new materials and pharmacologic and biologic prevention agents., Summary: There is great interest in new adhesion prevention technologies, but new agents are unlikely to be available for clinical use for many years. High-quality effectiveness and outcomes-related research is still needed.

Background: Endometrial cryoablation causes cryonecrosis of the endometrial lining as treatment for abnormal uterine bleeding in premenopausal women who have no desire for future fertility. Extended freezes to potentially improve efficacy have been described in the literature, although no associated complications have been reported., Case: We present 2 cases of ureteral stricture and sigmoid colon perforation in separate patients following extended freeze cryoendometrial ablation. Both patients had a preexisting uterine scar from prior cesarean section or myomectomy., Conclusion: Patients with a prior uterine incision may be at increased risk for complications from extended freeze endometrial cryoablation.

Objective: Multiple reports suggest that laparoendoscopic single-site surgery is technically feasible, safe, and effective in treating a variety of gynecological disease processes. The study purpose was to assess the feasibility and safety of a novel robotic single-site platform (R-LESS) for the surgical treatment of benign and malignant gynecological conditions., Study Design: A single-institution, prospective analysis of 40 women treated with R-LESS on the gynecology and gynecological oncology services from June 2013 through March 2014. Women undergoing hysterectomy or adnexal surgery for either a benign or malignant gynecological condition were offered robotic single-site surgery during the study period of June 1, 2013, through April 1, 2014. Patients underwent surgery through a single 2.5-3.0 cm umbilical incision with a multichannel port and utilizing the da Vinci robotic single-site platform. Two surgeons with extensive laparoendoscopic single-site experience participated., Results: Forty patients had R-LESS performed. Procedures included total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, salpingo-oophorectomy, ovarian cystectomy, excision of endometriosis, and a combined case of total laparoscopic hysterectomy and cholecystectomy. Median age and body mass index were 42 years and 28.2 kg/m(2), respectively. Median operating time, defined as the interval between incision start to closure, was 134 minutes (range, 84-311 minutes). Median vaginal cuff closure was 21 minutes (range, 9-77 minutes). Overall, there appeared to be a linear relationship between vaginal cuff closure time, console time, and operating time with number of cases performed. Procedures were successfully performed via R-LESS in 92.5% of cases; 2 cases required 1 additional port and there was 1 conversion to traditional multiport robotic surgery. There was 1 major postoperative complication (2.5%) and 1 readmission (2.5%). After a median follow-up period of 230 days (range, 61-256), there have been no postoperative hernias diagnosed., Conclusion: We present one of the first series of robotic laparoendoscopic single-site surgery for the treatment of various gynecological conditions. When performed by experienced minimally invasive surgeons, R-LESS is feasible and safe in select patients. Further studies are needed to better define the ideal gynecological procedures to perform using robotic single-site surgery and to assess the benefits and costs of R-LESS compared with multiport robotic and conventional laparoscopic approaches., (Copyright © 2015. Published by Elsevier Inc.)

Objective: To describe a technique for contained power morcellation within an insufflated isolation bag at the time of uterine specimen removal during minimally invasive gynecologic procedures., Methods: Over the study period of January 2013 to April 2014, 73 patients underwent morcellation of the uterus or myomas within an insufflated isolation bag at the time of minimally invasive hysterectomy or myomectomy. This technique involves placing the specimen into a large plastic bag within the abdomen, exteriorizing the opening of the bag, insufflating the bag within the peritoneal cavity, and then using a power morcellator within the bag to remove the specimen in a contained fashion. Procedures were performed at four institutions and included multiport laparoscopy, single-site laparoscopy, multiport robot-assisted laparoscopy, or single-site robot-assisted laparoscopy. Demographic and perioperative characteristics were collected for the cases., Results: Surgical specimen morcellation within an insufflated isolation bag was successfully used in all cases. The median operative time was 114 minutes (range 32-380 minutes), median estimated blood loss was 50 mL (range 10-500 mL), and the median specimen weight was 257 g (range 53-1,481 g). There were no complications related to the contained morcellation technique nor was there visual evidence of tissue dissemination outside of the isolation bag., Conclusion: Morcellation within an insufflated isolation bag is a feasible technique. Methods for morcellating uterine tissue in a contained manner may provide an option to minimize the risks of open power morcellation while preserving the benefits of minimally invasive surgery., Level of Evidence: II.

The objectives of this review were to analyze the literature describing the benefits of minimally invasive gynecologic surgery in obese women, to examine the physiologic considerations associated with obesity, and to describe surgical techniques that will enable surgeons to perform laparoscopy and robotic surgery successfully in obese patients. The Medline database was reviewed for all articles published in the English language between 1993 and 2013 containing the search terms "gynecologic laparoscopy" "laparoscopy," "minimally invasive surgery and obesity," "obesity," and "robotic surgery." The incidence of obesity is increasing in the United States, and in particular morbid obesity in women. Obesity is associated with a wide range of comorbid conditions that may affect perioperative outcomes including hypertension, atherosclerosis, angina, obstructive sleep apnea, and diabetes mellitus. In obese patients, laparoscopy or robotic surgery, compared with laparotomy, is associated with a shorter hospital stay, less postoperative pain, and fewer wound complications. Specific intra-abdominal access and trocar positioning techniques, as well as anesthetic maneuvers, improve the likelihood of success of laparoscopy in women with central adiposity. Performing gynecologic laparoscopy in the morbidly obese is no longer rare. Increases in the heaviest weight categories involve changes in clinical practice patterns. With comprehensive and thoughtful preoperative and surgical planning, minimally invasive gynecologic surgery may be performed safely and is of particular benefit in obese patients., (Copyright © 2014 AAGL. Published by Elsevier Inc. All rights reserved.)

Study Objective: To determine factors associated with hysteroscopic sterilization success and whether it differs between the operating room and office settings., Design: Retrospective cohort analysis (Canadian Task Force classification II-2)., Setting: Major university medical center., Patients: Six hundred thirty-eight women who underwent hysteroscopic sterilization between July 1, 2005, and June 30, 2011., Measurements and Main Results: Data collected included age, body mass index, previous office procedures, previous cesarean section, and presence of myomas or retroverted uterus. Place of surgery, experience of surgeon, insurance type, bilateral device placement, compliance with hysterosalpingography, and confirmation of occlusion were also recorded. Bivariate analysis of patient characteristics between groups was performed using χ(2) and independent t tests, and identified confounders and associated variables. Multivariate analysis was performed using logistic regression to assess for association and to adjust for confounders. Procedures were performed in the operating room (57%) or in the office (43%). There was no association between success in bilateral device placement or occlusion and any patient characteristic, regardless of surgery setting. Private insurance, patient age, and performance of procedures in the office setting were positively associated with likelihood of compliance with hysterosalpingography., Conclusion: Successful device placement and tubal occlusion are independent of patient age, body mass index, or setting of the procedure. Association between insurance type and completing hysterosalpingography illustrates an important public health problem. Patients who fail to undergo hysterosalpingography to confirm tubal occlusion may unknowingly be at risk of pregnancy and increased risk of ectopic pregnancy., (Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.)

The incidence of adnexal masses in pregnancy is estimated to be 1% to 4%. In select cases, surgical intervention is required. Recent studies have demonstrated that laparoscopy during pregnancy is safe and confers many advantages over laparotomy. Herein we present a series of nine cases collected prospectively that demonstrate the feasibility, safety, and putative benefits of laparoendoscopic single-site surgery for treatment of adnexal masses in pregnant women., (Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.)

Purpose: The present study is the first randomized clinical trial designed to evaluate the intraocular pressure (IOP)-lowering effect of anecortave acetate (AA) administered at 3 doses (3, 15, or 30 mg) as an anterior juxtascleral depot (AJD) in patients experiencing elevated IOP due to corticosteroid therapy., Methods: This was a double-masked, randomized, placebo-controlled, multicenter, parallel group trial. Eligible patients had an IOP of at least 24 mmHg and an IOP increase of at least 10 mmHg relative to their IOP before treatment with steroids. A target IOP was established for each patient at baseline. Patients were randomized to 1 of the 4 treatment groups: vehicle, 3 mg AA, 15 mg AA, or 30 mg AA. All patients then received a 0.5 mL AJD of the assigned treatment. Patients returned for scheduled examination visits at weeks 1, 2, 4, 6, months 3, 4, 5, and 6. IOP was measured at each visit as well as best corrected visual acuity (logMAR), ocular motility, eyelid responsiveness, slit lamp examination, and assessment of any adverse events. In addition, at baseline and at exit, a dilated fundus examination was carried out and the lens was examined using LOCS II criteria., Results: Seventy patients were randomized to treatment. At week 4, eyes in the vehicle group showed a 3.4 mmHg (9.1%) decrease from baseline. Reductions for the 3 mg AA (3.1 mmHg, 10.7%) and the 30 mg AA groups (5.4 mmHg, 16.6%) were not significantly different than for vehicle control. However, IOP for the 15 mg AA group at week 4 was reduced 11.5 mmHg (31.3%) from baseline, which was statistically significant (P=0.0487). The mean time to treatment failure was 32.2, 38.9, 56.3, and 32.6 days for the vehicle, 3 mg AA, 15 mg AA, and 30 mg AA groups, respectively. Adverse events were assessed at each post-treatment visit. There were no serious adverse events that were determined to be related to the test article or its administration., Conclusions: AA can be of benefit to some patients requiring treatment with corticosteroids, but suffering from the side effect of elevated IOP.

Purpose: To describe the safety profile and clinical response on elevated intraocular pressure (IOP) of betaxolol hydrochloride ophthalmic suspension 0.25% (betaxolol) and timolol maleate ophthalmic gel-forming solution (TGFS) (0.25% and 0.5%), in subjects under 6 years of age., Methods: Subjects were randomized to betaxolol 0.25% (twice daily) or TGFS (daily) (0.25% or 0.5%) in this double-masked study. IOPs were obtained at the same time of day (9 AM) at 2 baseline visits and weeks 2, 6, and 12. Mean change from baseline in IOP was the primary efficacy parameter., Results: One hundred five subjects were randomized (34 to betaxolol, 35 to TGFS 0.25%, 36 to TGFS 0.5%). Betaxolol, TGFS 0.25%, and TGFS 0.5% produced statistically significant mean reductions in IOP; mean reductions after 12 weeks of treatment were 2.3, 2.9, and 3.7 mm Hg, respectively. In subjects who were not being treated with topical IOP-lowering medication at baseline, mean IOP reductions after 12 weeks of treatment were 3.1, 4.8, and 3.8 mm Hg, respectively. In patients discontinuing 1 or more topical IOP-lowering medications at baseline, mean IOP reductions at Week 12 were 1.8, 1.8, and 3.7 mm Hg, respectively. Responder rates (> or =15% reduction from baseline) for betaxolol, TGFS 0.25%, and TGFS 0.5% were 38.2, 45.7, and 47.2%, respectively. Adverse events were predominantly nonserious and did not interrupt patient continuation in the study., Conclusions: Betaxolol ophthalmic suspension 0.25%, TGFS 0.25%, and TGFS 0.5% were well tolerated. Despite low responder rates, all 3 treatments produced statistically significant mean reductions in IOP in pediatric glaucoma subjects.

Purpose: To describe the intraocular pressure (IOP)-lowering effects in eyes with open-angle glaucoma (OAG) after treatment with an anterior juxtascleral depot of anecortave acetate., Design: Prospective, interventional case series., Methods: Seven eyes of six subjects with OAG, with uncontrolled IOP while being administered one or more topical medications, received 24 mg anecortave acetate delivered by anterior juxtascleral depot. IOP was assessed at baseline and regularly after treatment for up to 24 months., Results: Mean IOP before anecortave acetate treatment was 31.3 +/- 11.3 mm Hg and dropped by 9.5 +/- 4.5 mm Hg (32.7% +/- 16.8%) within one week after treatment. This IOP reduction was sustained through six months (8.4 +/- 5.4 mm Hg [29.6% +/- 12.4%]) and 12 months (9.5 +/- 5.7 mm Hg [34.0% +/- 15.9%]) after a single anecortave acetate treatment. The injection process was well tolerated, and no eyes experienced any injection-related or drug-related serious adverse events., Conclusions: Both the anterior juxtascleral depot of a drug and anecortave acetate may be promising candidates for IOP reduction in eyes with OAG. Additional studies are required to establish better their efficacy and safety, optimal dosing frequency, mechanism of action, and potential additivity to other IOP-lowering therapies.

Purpose: To describe the safety and clinical response on elevated intraocular pressure (IOP) of brinzolamide and levobetaxolol in pediatric patients under 6 years of age., Methods: A double-masked, randomized design. Pediatric patients were randomized to brinzolamide suspension, 1%, or levobetaxolol suspension, 0.5%, both dosed twice daily. IOPs at 9 AM were taken at screening, baseline, and weeks 2, 6, and 12. A descriptive study with mean change from baseline IOP, the primary efficacy parameter., Results: Seventy-eight evaluable patients (32 brinzolamide and 46 levobetaxolol). Patients on no prestudy IOP-lowering therapy randomized to brinzolamide had mean IOP change from baseline ranging from -4.1 mm Hg (week 2) to -5.0 mm Hg (week 6). When all brinzolamide patients are considered, there was little mean change from baseline IOP due to the large number of patients enrolled without a washout of prior IOP-lowering therapy. Levobetaxolol patients had mean change from baseline, ranging from -1.8 mm Hg (week 6) to -2.9 mm Hg (week 2). Levobetaxolol patients on no prestudy therapy had mean IOP change from baseline ranging from -2.9 mm Hg (week 12) to -4.0 mm Hg (week 2). Brinzolamide was more efficacious for glaucoma associated with systemic or ocular abnormalities and less efficacious for primary congenital glaucoma. Levobetaxolol was most efficacious for primary congenital glaucoma. Adverse events were predominantly nonserious and did not interrupt patient continuation in the study., Conclusions: Both brinzolamide and levobetaxolol were well tolerated. Both drugs provided clinically relevant IOP reductions for patients not on a previous medication, although efficacy is, in part, contingent upon diagnosis.

We conducted a series of surgical studies (n=155) to find out the possible utility of the Dutch Belted rabbits as an ocular test model. Following either vitrectomy (n=59) or lensectomy (n=96) studies using either BSS or BSS Plus, we characterized the corresponding magnitude and duration of inflammatory response of selected endpoints over a one-week period. Preoperative Dutch Belted rabbits served as controls for baseline determination (n=27). Inflammatory endpoints included clinical inflammation, blood aqueous barrier (BAB) changes measured by particle-scatter and fluorophotometry, corneal edema, and prostaglandin-E2 (PGE2). Topical ocular 0.1% dexamethasone (MAXIDEX) served as a positive treatment group. We compared the inflammatory features (treated and untreated) to determine significance. Using either irrigating solution, the endpoints (n=101) were shown increased in both models. While the clinical scores were similar following both types of surgery (ns; p=0.51), the lensectomy study caused a more marked effect on corneal edema (p=0.0004) and PGE2 production (p=0.002) compared with the vitrectomy study. After the lensectomy procedure, BSS Plus (n=52) compared with BSS (n=24) showed a significant improvement (p=0.004) of clinical score during the recovery phase. Further improvement was gained over BSS Plus (n=52) using MAXIDEX treatment. Topical MAXIDEX (lensectomy, n=20/group; vitrectomy, n=12/group) reduced clinical score (p<0.001), decreased BAB breakdown to fluorescein (p<0.01), lessened particle flare (p<0.05), inhibited aqueous PGE2 levels (p<0.001), and reduced corneal edema (p=0.01) in the lensectomy group. The use of the rabbit model offers a convenient test to identify therapeutic agents that could lessen ocular complications after these common ocular surgeries.

This study reports for the first time a therapeutic modality for the suppression of posterior subcapsular cataract (PSC) formation in an animal model (rabbit) of vitrectomy. This therapeutic modality may also have the potential to attenuate/prevent the high incidence of loss of vision due to cataract formation in patients that undergo vitrectomy. Unilateral, partial vitrectomy was performed on 2.5 month old Dutch Belted rabbits with vitreous replaced by either commercially available BSS((R)) or BSS PLUS((R)) (n=16). Alternatively, vitreous was replaced with a proprietary, modified BSS PLUS((R)) irrigating solution containing 1.25 microM AL-8417 (n=12), 5.0 microM AL-12615 (n=5) or 5.0 microM AL-17052 (n=9). Age matched, non-operated rabbits were used as controls (n=16). Lenses were analysed by correlative structural (light, scanning electron microscopic and three-dimensional computer-assisted drawings) and optical (low power helium-neon laser scan) quality analysis 6 months following surgery. Results demonstrate that vitreous replacement with an irrigating solution that contains the ester-linked benzopyran, AL-8417, the amide-linked benzopyran pro-drug, AL-17052, or its active metabolite, AL-12615, prevented abnormal post-vitrectomy lens growth, or fiber formation. Focal length variability (FLV) assessments (sharpness of focus) confirmed the beneficial drug effects detected morphologically, with FLV being essentially equal to that of age-matched, non-surgical controls. In contrast, lenses of animals with vitreous replaced solely with BSS((R)) or BSS PLUS((R)) exhibited significantly higher FLV than both age-matched controls and animals that underwent vitrectomy with drug-containing irrigating solutions. The ability of AL-8417, AL-17052 and its active metabolite, AL-12615, to suppress vitrectomy-induced posterior lens fiber changes appears to reside in their unique pharmacological profile, acting as antioxidant, anti-inflammatory and cytostatic agents.