Hyderabad, Aug 10: BostonSight and L V Prasad Eye Institute announced the initiation of a prospective clinical trial to evaluate the effect of PROSE and SCLERAL lenses on mental health. This marks a step in BostonSight’s ongoing research into the efficacy of the lenses in improving quality of life of users, going beyond its previous research on impact on cornea and ocular surface. The Institutional Review Board approved study is a multi-site study involving the lens users referred to LVPEI from across the country and beyond. The study will focus on evaluating mental health outcomes of patients who have had BostonSight PROSE and SCLERAL lenses fitted.
LVPEI is a long-term partner of BostonSight, distributing PROSE and SCLERAL lenses in India and the surrounding region. BostonSight PROSE and SCLERAL lenses are custom, non-surgical medical lenses that help people with corneal and ocular surface diseases find lasting comfort, clarity, and quality of life. BostonSight PROSE and BostonSight SCLERAL are both part of custom medical treatments and are FDA-cleared medical devices. BostonSight SCLERAL is a commercially available lens used for mild to moderate corneal and ocular surface disease conditions.
Key details of the study:
·Target Population: New PROSE patients
·Primary Objectives: Identify direct correlation between quantifiable mental health outcomes and specialty lens treatment
·Study Design: Measure mental health with the Patient Health Questionnaire-9 and evaluate ocular surface symptoms with the Ocular Surface Disease Index and visual functioning with Visual Function Questionnaire-25 to see how changes in mental health may relate to specific scores on vision centered questionnaires
·Expected Impact: Raise awareness on mental health challenges associated with ocular surface disease and promote early interventions with PROSE, to improve or avoid associated mental health conditions.
“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.” said Dr Prashant Garg, Executive Chair- LVPEI.
“Mental health is an often overlooked or under-appreciated part of caring for patients with ocular surface disease,” said Dr Daniel Brocks, Chief Medical Officer – 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 interventions in a patient’s eye care journey, with PROSE and other specialty lenses.”