Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
120

Summary

Conditions
Age - Related Macular Degeneration
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Prospective, non-randomized, unmasked clinical studyMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 50 years and 100 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT04268836
Collaborators
Bochner Eye Institute
Investigators
Study Director: Michael Berry, PhD Optimal Acuity Corporation
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