Low Vision Aid System for Age-Related Macular Degeneration
(AMD Trial)
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Optimal Acuity Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
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.
Research Team
MB
Michael Berry, PhD
Principal Investigator
Optimal Acuity Corporation
Eligibility Criteria
This trial is for people over 50 with age-related macular degeneration (AMD) in one or both eyes, confirmed by a retina specialist. Participants must have moderate to severe vision impairment due to AMD but no significant cataracts or corneal diseases. They should not wear contact lenses and must be able to give informed consent.Inclusion Criteria
I am 50 years old or older.
You do not wear contact lenses.
I am either male or female.
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Exclusion Criteria
I have high eye pressure or a history of glaucoma.
Corneal topographic astigmatism greater than 2.00 D (mean value within 3.0 mm optical zone)
Potential Visual Acuity (PVA) in both eyes that is not improved by at least three lines compared to CDVA
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Patients are treated by the Optimal Acuity Clear-K Low Vision Aid System
Immediate
Follow-up
Participants are monitored for safety and effectiveness after treatment
24 months
Treatment Details
Interventions
- Optimal Acuity Clear-K® Low Vision Aid System
Trial Overview The study tests the Optimal Acuity Clear-K® Low Vision Aid System's effectiveness and safety in improving vision for those with AMD. It aims to see if this treatment can help patients see better.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment armExperimental Treatment1 Intervention
Patients will be treated by the Optimal Acuity Clear-K Low Vision Aid System.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Optimal Acuity Corporation
Lead Sponsor
Trials
4
Recruited
310+
Bochner Eye Institute
Collaborator
Trials
2
Recruited
220+
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