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Corneal tissue addition keratoplasty is a novel surgical procedure utilizing preserved allogenic femtosecond laser–shaped corneal tissue inlays to improve corneal topography and vision in patients with keratoconus and ectasia. Purpose: To report results of Corneal Tissue Addition Keratoplasty (CTAK) for keratoconus (KC) and ectasia after laser in situ keratomileusis. Setting: Cornea and refractive surgery practice. Design: Single center, prospective, open label clinical trial. Methods: 21 eyes of 18 patients underwent CTAK. A tissue inlay of preserved corneal tissue was cut to customized specifications with a femtosecond laser and placed in a laser-created channel in the host cornea. Postoperative uncorrected and corrected distance visual acuity (UDVA, CDVA), manifest refraction spherical equivalent (MRSE), topographic mean keratometry (Kmean), maximum keratometry (Kmax), and the point of maximum flattening (Kmaxflat) were measured. Results: Average UDVA improved from 1.21 ± 0.35 logMAR lines (LL) (20/327) to 0.61 ± 0.25 LL (20/82) (P <.001). Average CDVA improved from 0.62 ± 0.33 LL (20/82) to 0.34 ± 0.21 LL (20/43) (P =.002), and average MRSE improved from −6.25 ± 5.45 diopters (D) to −1.61 ± 3.33 D (P =.002). Individually, 20 eyes (95.2%) gained more than 2 lines of UDVA, with 10 eyes (47.6%) gaining more than 6 lines, and no eyes worsening. 12 eyes (57.1%) gained at least 2 lines of CDVA, with 1 eye worsening by more than 2 lines. At 6 months, average Kmean flattened by −8.44 D (P =.002), Kmax flattened by −6.91 D (P =.096), and mean Kmaxflat was −16.03 D. Conclusions: CTAK is a promising procedure to improve visual acuity and topography in patients with KC and ectasia. [ABSTRACT FROM AUTHOR]

Purpose: To assess anterior corneal higher-order aberrations (HOAs) after corneal crosslinking (CXL) and intrastromal corneal ring segments (Intacs) used adjunctively. Setting: Cornea and refractive surgery practice. Design: Prospective, randomized clinical trial. Methods: One hundred fifty-eight eyes of 150 patients were randomized into 2 groups: concurrent, Intacs and CXL during the same session (n = 81), or sequential, Intacs followed by CXL 3 months later (n = 77). Outcomes included changes in total, coma, trefoil, and spherical anterior corneal HOA 6 months after Intacs/CXL. The change in anterior corneal HOAs was correlated with the change in uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and topography indices of maximum keratometry (Kmax), maximum flattening keratometry (Kmaxflat), and inferior-superior (I-S) ratio. A subjective visual function questionnaire was also analyzed. Results: UDVA, CDVA, Kmax, I-S, and Kmaxflat all improved 6 months after treatment (UDVA = -0.22 +/- 0.34, P <.001; CDVA = -0.13 +/- 0.24, P <.001; Kmax = -3.1 +/- 3.0D, P <.001; I-S = -4.2 +/- 5.0 diopters [D], P <.001; Kmaxflat = -7.9 +/- 4.0 D, P <.001). Total anterior corneal HOA, vertical coma, and horizontal coma anterior corneal HOAs significantly improved by -1.05 +/- 0.93 [mu]m (P <.001), -1.53 +/- 1.18 [mu]m (P <.001), and -0.35 +/- 0.57 [mu]m (P <.001), respectively. Spherical anterior corneal HOAs increased by 0.24 +/- 0.70 [mu]m (P <.001) at 6 months after Intacs/CXL. The change in trefoil was not statistically significant (P trefoil0 =.06, P trefoil30 =.2). There were no significant differences between the changes in anterior corneal HOAs in the sequential and same-day Intacs/CXL groups. The change in total anterior corneal HOAs was correlated with Kmax, Kmaxflat, and the I-S ratio. There was no correlation between the change in anterior corneal HOAs and the change in visual acuity or visual function survey responses. Conclusions: Total, horizontal coma, and vertical coma anterior corneal HOAs improved after Intacs/CXL. Spherical anterior corneal HOAs increased postoperatively, and there was no change in trefoil. Improvement of anterior corneal HOAs did not correlate with visual acuity improvement or subjective visual satisfaction outcomes. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate 1-year outcomes of corneal collagen crosslinking (CXL) for treatment of keratoconus and corneal ectasia. Setting: Cornea and refractive surgery subspecialty practice. Design: Prospective randomized controlled clinical trial. Methods: Collagen crosslinking was performed in eyes with keratoconus or ectasia. The treatment group received standard CXL and the sham control group received riboflavin alone. Principal outcomes included uncorrected (UDVA) and corrected (CDVA) distance visual acuities, refraction, astigmatism, and topography-derived outcomes of maximum and average keratometry (K) value. Results: The UDVA improved significantly from 0.84 logMAR ± 0.34 (SD) (20/137) to 0.77 ± 0.37 logMAR (20/117) (P = .04) and the CDVA, from 0.35 ± 0.24 logMAR (20/45) to 0.23 ± 0.21 logMAR (20/34) (P<.001). Fifteen patients (21.1%) gained and 1 patient lost (1.4%) 2 or more Snellen lines of CDVA. The maximum K value decreased from baseline by 1.7 ± 3.9 diopters (D) (P<.001), 2.0 ± 4.4 D (P = .002), and 1.0 ± 2.5 D (P = .08) in the entire cohort, keratoconus subgroup, and ectasia subgroup, respectively. The maximum K value decreased by 2.0 D or more in 22 patients (31.0%) and increased by 2.0 D or more in 3 patients (4.2%). Conclusions: Collagen crosslinking was effective in improving UDVA, CDVA, the maximum K value, and the average K value. Keratoconus patients had more improvement in topographic measurements than patients with ectasia. Both CDVA and maximum K value worsened between baseline and 1 month, followed by improvement between 1, 3, and 6 months and stabilization thereafter. Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned. Additional disclosure is found in the footnotes. [Copyright &y& Elsevier]

Purpose: To determine the natural history of collagen crosslinking (CXL)–associated corneal haze measured by Scheimpflug imagery and slitlamp biomicroscopy in patients with keratoconus or ectasia after laser in situ keratomileusis. Setting: Cornea and refractive surgery subpecialty practice, United States. Design: Prospective randomized controlled clinical trial. Methods: The treatment group received ultraviolet-A/riboflavin CXL therapy. The control group received riboflavin alone without epithelial debridement. To objectively measure CXL-associated corneal haze, corneal densitometry using Scheimpflug imagery was measured and the changes in haze were analyzed over time. A similar analysis was performed using clinician-determined slitlamp haze. Correlation of CXL-associated corneal haze with postoperative outcomes was analyzed. Results: The mean preoperative corneal densitometry was 14.9 ± 1.93 (SD) (Pentacam Scheimpflug densitometry units). Densitometry peaked at 1 month (mean 23.4 ± 4.40; P<.001), with little change at 3 months (mean 22.4 ± 4.79; P = .06) and decreased between 3 months and 6 months (19.4 ± 4.48; P<.001) and between 6 months and 12 months. By 12 months, densitometry had not completely returned to baseline in the entire cohort (mean 17.0 ± 3.82; P<.001) and the keratoconus subgroup; however, it returned to baseline in the ectasia group (16.1 ± 2.41; P = .15). The postoperative course of slitlamp haze was similar to objective densitometry measurements. Increased haze, measured by densitometry, did not correlate with postoperative clinical outcomes. Conclusions: The time course of corneal haze after CXL was objectively quantified; it was greatest at 1 month, plateaued at 3 months, and was significantly decreased between 3 months and 12 months. Changes in haze did not correlate with postoperative clinical outcomes. Financial Disclosure: Drs. Greenstein and Fry and Ms. Bhatt have no financial or proprietary interest in any material or method mentioned. Additional disclosures are found in the footnotes. [Copyright &y& Elsevier]

To assess outcomes of corneal crosslinking (CXL) and intracorneal ring segments (ICRS) (Intacs) used adjunctively, and then compare the safety and efficacy of concurrent versus sequential surgery. Cornea and refractive surgery subspecialty practice. Prospective randomized clinical trial. Patients were randomized to one of two groups: ICRS first, immediately followed by CXL during the same session (n = 104), or ICRS followed by CXL 3 months later (n = 94). Outcomes included changes in maximum keratometry (K) and topographic inferior–superior (I–S) difference, maximum flattening of topographic K, and changes in uncorrected (UDVA) and corrected (CDVA) distance visual acuities. These were analyzed in the entire cohort, in the two randomized groups, and in subgroups stratified to ICRS size and placement. Patients were followed for 6 months. The study comprised 198 eyes of 198 patients. Overall, maximum K decreased by an average of 2.5 D, I–S difference improved by 3.9 D, and there was an average maximum flattening of −7.5 D. The UDVA improved by 2.0 logarithm of the minimum angle of resolution lines, on average, and the CDVA improved by 1.1 lines. There was no significant difference between the sequential and concurrent groups in any of the outcomes analyzed. There were 6 clinically significant adverse events. CXL and ICRS can be used adjunctively with substantial improvement in corneal topography, and with no increase in safety concerns over each procedure alone. Sequential and concurrent treatment with ICRS and CXL show equivalent outcomes. Both thicker segment size and single segment placement seem to result in greater topographic improvement. [ABSTRACT FROM AUTHOR]