By: IPP Bureau
Last updated : August 10, 2026 8:23 pm
BostonSight PROSE and BostonSight SCLERAL are FDA-cleared medical devices used as part of customized medical treatment
BostonSight and L V Prasad Eye Institute (LVPEI) have initiated a prospective clinical trial to evaluate the impact of PROSE and SCLERAL lenses on mental health among patients with corneal and ocular surface diseases.
The Institutional Review Board (IRB)-approved, multi-site study marks a new phase in BostonSight’s research into the benefits of specialty lenses, expanding beyond their established impact on the cornea and ocular surface to examine potential improvements in patients’ mental health and overall quality of life.
The study will involve new PROSE patients referred to LVPEI from across India and beyond. Researchers will assess mental health outcomes following fitting with BostonSight PROSE and SCLERAL lenses and examine whether improvements in vision and ocular comfort are associated with measurable changes in mental health.
The primary objective is to establish a direct correlation between quantifiable mental health outcomes and specialty lens treatment. The study will use the Patient Health Questionnaire-9 (PHQ-9) to measure mental health, the Ocular Surface Disease Index (OSDI) to assess ocular surface symptoms, and the Visual Function Questionnaire-25 (VFQ-25) to evaluate visual functioning.
By comparing changes across these measures, researchers aim to understand how improvements in ocular symptoms and visual function may relate to changes in patients’ mental health.
BostonSight PROSE and SCLERAL lenses are custom, non-surgical medical devices designed to provide comfort, improve vision and support quality of life for people living with corneal and ocular surface diseases.
BostonSight PROSE and BostonSight SCLERAL are FDA-cleared medical devices used as part of customized medical treatment. BostonSight SCLERAL is also commercially available for patients with mild to moderate corneal and ocular surface conditions.
Dr. Prashant Garg, Executive Chair, LVPEI, said, “IRB approval is an important milestone that confirms the study meets established ethical and regulatory standards. We are excited to move forward with this important study to evaluate quantifiable mental health outcomes associated with these specialty lenses.”
Dr. Daniel Brocks, Chief Medical Officer, BostonSight, said mental health is often overlooked in the care of patients with ocular surface disease. He noted that improvements in vision, ocular comfort and ocular health can have a significant effect on mental well-being and said the study aims to objectively measure this impact.