BostonSight announced they have initiated a prospective clinical trial to evaluate the effect that PROSE treatment and scleral lenses may have on mental health. This milestone marks an important step in BostonSight’s ongoing research into the efficacy of PROSE treatment and scleral lenses beyond the cornea and ocular surface.
The Institutional Review Board (IRB)-approved study is a multi-site study in partnership with L V Prasad Eye Institute (LVPEI) in Hyderabad, India. LVPEI is a long-term partner of BostonSight, providing PROSE treatment and BostonSight SCLERAL distribution to India and the surrounding region. The study will focus on evaluating mental health outcomes following patients who have had PROSE treatment or who have been fit with BostonSight SCLERAL lenses.
PROSE treatment by BostonSight is a custom, non-surgical medical treatment that helps people living with corneal and ocular surface disease find lasting comfort, clarity, and quality of life. It integrates medical treatment with highly customized scleral lenses, which are FDA-cleared medical devices. BostonSight SCLERAL is a commercially available lens that is used for mild to moderate corneal and ocular surface disease conditions.
“IRB approval is an important milestone that confirms this 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,” said Dr. Prashant Garg, Executive Chair, LVPEI.
“Mental health is an often overlooked or underappreciated part of caring for ocular surface disease patients,” said Daniel Brocks, MD, Chief Medical Officer at BostonSight. “The often-dramatic effect that improved vision, ocular comfort, and ocular health can have on mental health is something we see every day. With this study, we hope to objectively measure this effect, which could further support earlier intervention with PROSE treatment and specialty lenses in a patient’s eye care journey.”
Key details of the study include:
- Target Population: New PROSE and BostonSight SCLERAL patients
- Primary Objectives: Identify direct correlation between quantifiable mental health outcomes and specialty lens treatment.
- Study Design: Measuring mental health with the PHQ-9 questionnaire and evaluating ocular surface symptoms with the OSDI and visual functioning with VFQ-25 to see how changes in mental health may relate to specific scores on vision centered questionnaires.
- Expected Impact: Raise awareness of mental health challenges associated with ocular surface disease and promote early intervention with PROSE treatment to improve or avoid associated mental health conditions.
For questions, inquiries, or additional information, please contact Estelle Crowley, Clinical Research Coordinator at [email protected] or by phone at 781-726-7337.