Key Takeaways

  • BostonSight and L V Prasad Eye Institute have initiated an IRB-approved prospective, multisite study examining mental health outcomes in new PROSE treatment and BostonSight Scleral patients
  • The study could help clarify whether improvements associated with specialty lens treatment correspond with measurable changes in mental health among patients with corneal and ocular surface disease

BostonSight has initiated a prospective, multisite clinical trial evaluating the potential effects of PROSE treatment and scleral lens use on mental health among patients with corneal and ocular surface disease.

The Institutional Review Board-approved study is being conducted in partnership with L V Prasad Eye Institute (LVPEI) in Hyderabad, India. The organizations have a longstanding collaboration, with LVPEI providing PROSE treatment and distributing BostonSight Scleral lenses in India and the surrounding region.

Investigators will enroll new patients receiving PROSE treatment or being fitted with BostonSight Scleral lenses and assess changes in mental health alongside ocular surface symptoms and visual function.

“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,” Prashant Garg, MD, executive chair of LVPEI, said in the announcement.

The study is designed to investigate whether measurable changes in mental health correlate with specialty lens treatment. Investigators will use the Patient Health Questionnaire-9 (PHQ-9) to assess mental health outcomes. Ocular surface symptoms will be evaluated using the Ocular Surface Disease Index (OSDI), while visual functioning will be measured with the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25). Researchers will examine how changes in mental health relate to scores on these vision- and ocular surface-focused measures.

PROSE treatment is a customized, nonsurgical treatment for patients with corneal and ocular surface disease that combines medical management with individually customized scleral lenses, which are FDA-cleared medical devices. BostonSight Scleral is a commercially available lens used for patients with mild to moderate corneal and ocular surface disease.