The Convergence Insufficiency Neuro-mechanism in Adult Population Study (CINAPS) Randomized Clinical Trial: Design, Methods, and Clinical Data
Document Type
Article
Publication Date
1-2-2020
Abstract
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.
Identifier
85074523173 (Scopus)
Publication Title
Ophthalmic Epidemiology
External Full Text Location
https://doi.org/10.1080/09286586.2019.1679192
e-ISSN
17445086
ISSN
09286586
PubMed ID
31640452
First Page
52
Last Page
72
Issue
1
Volume
27
Grant
NEI
Fund Ref
Foundation for the National Institutes of Health
Recommended Citation
Alvarez, Tara L.; Scheiman, Mitchell; Santos, Elio M.; Morales, Cristian; Yaramothu, Chang; D’Antonio-Bertagnolli, John Vito; Biswal, Bharat B.; Gohel, Suril; and Li, Xiaobo, "The Convergence Insufficiency Neuro-mechanism in Adult Population Study (CINAPS) Randomized Clinical Trial: Design, Methods, and Clinical Data" (2020). Faculty Publications. 5534.
https://digitalcommons.njit.edu/fac_pubs/5534
