NCT04268836

Vision Improvement for Patients With Age-Related Macular Degeneration

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Optimal Acuity Corporation · Industry
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether the Optimal Acuity Clear-K® Low Vision Aid System provides a safe and effective treatment to improve vision for patients with age-related macular degeneration.

Detailed description

The Optimal Acuity Clear-K® Low Vision Aid System treats corneas with near infrared light in order to change the modulus of small volumes of anterior stromal corneal tissue. The change of modulus produces a change of corneal stiffness and shape that modifies the distribution of light onto the retina. Light rays are redirected from dysfunctional areas of the retina that have been damaged by age-related macular degeneration (AMD) to functional areas of the retina, thereby improving patient vision. 200 AMD patients meeting eligibility requirements will be treated. The study will record and analyze pre-treatment (Tx) and post-Tx examinations with follow-up extending to 24 months post-Tx. Analysis will include descriptive statistics and measures of correlation between outcomes and patient baseline characteristics. The primary objective of the study is to evaluate the safety and effectiveness of Clear-K® treatment in providing vision improvement to AMD patients.

Conditions

• Age-related Macular Degeneration

Interventions

Type	Name	Description
DEVICE	Optimal Acuity Clear-K® Low Vision Aid System treatment	The treatment involves irradiation of the cornea with low energy light in a treatment pattern that produces corneal shape change.

Timeline

• Start date: 2024-01-09
• Primary completion: 2024-05-31
• Completion: 2025-05-01
• First posted: 2020-02-13
• Last updated: 2023-03-22

Locations

1 site across 1 country: Canada