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Purpose: To describe CONCUSS, a randomized clinical trial (RCT) designed to compare the following: the effectiveness of immediate office-based vergence/accommodative therapy with movement (OBVAM) to delayed OBVAM as treatments for concussion-related convergence insufficiency (CONC-CI) to understand the impact of time (watchful waiting), the effect of OBVAM dosage (12 versus 16 therapy sessions), and to investigate the underlying neuro-mechanisms of OBVAM on CONC-CI participants. Methods: CONCUSS is an RCT indexed on https://clinicaltrials.gov/study/NCT05262361 enrolling 100 participants aged 11–25 years with medically diagnosed concussion, persistent post-concussive symptoms 4–24 weeks post-injury, and symptomatic convergence insufficiency. Participants will receive standard concussion care and will be randomized to either immediate OBVAM or delayed (by six weeks) OBVAM. At the Outcome 1 examination (week 7), clinical assessments of success as determined by changes in the near point of convergence (NPC), positive fusional vergence (PFV), and symptoms will be compared between the two treatment groups. After the Outcome 1 visit, those in the delayed group receive 16 visits of OBVAM, while those in the immediate OBVAM group receive four more therapy visits. Outcome 2 assessment will be used to compare both groups after participants receive 16 sessions of OBVAM. The primary measure is the between-group differences of the composite change in the NPC and PFV at the Outcome 1 visit. Secondary outcome measures include individual clinical measures, objective eye-tracking parameters, and functional brain imaging. Conclusions: Major features of the study design include formal definitions of conditions and outcomes, standardized diagnostic and treatment protocols, a delayed treatment arm, masked outcome examinations, and the incorporation of objective eye movement recording and brain imaging as outcome measures. CONCUSS will establish best practices in the clinical care of CONC-CI. The objective eye movement and brain imaging, correlated with the clinical signs and symptoms, will determine the neuro-mechanisms of OBVAM on CONC-CI. [ABSTRACT FROM AUTHOR]

This study aims to assess oculomotor and vestibular endurance by utilizing the Oculomotor and Vestibular Endurance Screening (MoVES) assessment in athletes' pre-season and post-season and after a suspected head injury to detect impairment. Athletes (N = 311, 19.4 ± 1.3 years) were recruited to perform the following seven tasks: (1) horizontal saccades, (2) vertical saccades, (3) vergence jumps, (4) horizontal vestibular-oculomotor reflex (VOR), (5) vertical VOR, (6) amplitude of accommodation (AoA), and (7) near point of convergence (NPC). At pre-season, the observed number of eye movements in 60 s are horizontal saccades (74 ± 13 initial 30 s; 67 ± 11 latter 30 s), vertical saccades (70 ± 13; 66 ± 10), vergence jumps (48 ± 12; 45 ± 13), horizontal VOR (38 ± 11; 38 ± 11), and vertical VOR (8 ± 11; 38 ± 11). These results establish a normative database for eye movements within the MoVES assessment and show consistency in the number of movements from pre-season to post-season. The initial results show a trending decrease in the number of eye movements in the initial days post-head injury, which improves to pre-season measures 14–21 days post-injury. This foundation can be used by future studies to explore the extent of binocular and vestibular endurance dysfunctions caused by head injuries that subside within two weeks. [ABSTRACT FROM AUTHOR]

Purpose: To describe the design and methodology of the Convergence Insufficiency Neuro-mechanism in Adult Population Study (CINAPS), the first randomized clinical trial (RCT) studying young adults with symptomatic convergence insufficiency (CI) using a combination of traditional clinical tests, objective eye movement recordings, and functional brain activities as outcome measures. Methods: In this double-masked RCT, binocularly normal controls (BNC) (N = 50) and CI patients (N = 50) are randomized into office-based vergence/accommodative therapy (OBVAT) or office-based placebo therapy (OBPT). Outcome measures included clinical signs and symptoms, phoria adaptation, forced fixation disparity curves, binocular rivalry, vergence and saccadic objective eye movements, and task-induced functional brain activities. This study is registered on ClinicalTrials.gov NCT03593031. Results: No significant baseline differences are observed between the BNC (p >.4) or CI (p >.3) participants assigned to OBVAT or OBPT for age, near point of convergence (NPC), positive fusional vergence (PFV), phoria at distance and near, amplitude of accommodation, or the Convergence Insufficiency Symptom Survey (CISS). Significant differences are observed between the CI and BNC cohorts at baseline measurements for NPC, PFV, difference in phoria from far to near, amplitude of accommodation, and CISS (p <.001). For the CI patients, 26% had a comorbidity of accommodation insufficiency, and 16% self-reported ADHD. Conclusion: Features of the study design include the following: standardized diagnostic and office-based therapeutic intervention, placebo treatment arm, masked clinical outcome examinations, objective eye movement recordings, functional imaging, phoria adaptation, fixation disparity curves and binocular rivalry measurements. [ABSTRACT FROM AUTHOR]

Office-Based Vergence/Accommodative Therapy (OBVAT) is an effective treatment for convergence insufficiency (CI) and remediates symptoms in about 75% of patients. Hence, the study of CI patients can serve as a systems-level model to understand the neural mechanisms evoked from rehabilitation. Symptomatic young adult CI patients (N=25) participated in 12 hours of OBVAT and were compared to 25 binocularly normal controls (BNC) using unpaired t-tests. CI patients have significantly lower near point of convergence and positive fusional vergence and were more symptomatic compared to BNC (p<; 0.0001). Using paired t-tests, significant differences (p<; 0.0001) were observed between CI patients' baseline and post-OBVAT measurements where the near point of convergence decreased, positive fusional vergence increased, and the results from the Convergence Insufficiency Symptom Survey (CISS) decreased. Using paired t-tests, the mean beta weights of the functional activity significantly increased for the frontal eye fields (p<; 0.01) and the oculomotor vermis (p<; 0.05) for CI patients post-OBVAT compared to baseline measurements. These data demonstrate that OBVAT increases functional activity within the brain and improves clinical function and visual symptoms in CI patients.