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Low Vision Aid System

Low Vision Aid System for Age-Related Macular Degeneration (AMD Trial)

N/A
Waitlist Available
Research Sponsored by Optimal Acuity Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is at least 50 years old.
Patient has moderate to severe vision impairment due to dry age-related macular degeneration with best spectacle-corrected distance visual acuity (CDVA) of 20/80 or worse (decimal = 0.25 or less; logMAR ≥ 0.60) in the better eye.
Must not have
Increased intraocular pressure (above 20 mm Hg), glaucoma or history of glaucoma
Corneal disease or disorder in either eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether the Optimal Acuity Clear-K® Low Vision Aid System is a safe and effective treatment to improve vision for patients with age-related macular degeneration.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not specified, but as with any medical device affecting vision, there may be risks of discomfort, visual disturbances, or eye strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 50 years old or older.
Select...
My best vision with glasses is 20/80 or worse due to dry AMD.
Select...
I have had cataract surgery or don't have significant cataracts in the eye(s) to be treated.
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I have severe vision loss from dry age-related macular degeneration.
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My wet AMD is currently not active.
Select...
I am 50 years old or older.
Select...
I have been diagnosed with age-related macular degeneration in at least one eye.
Select...
I have been diagnosed with age-related macular degeneration in at least one eye.
Select...
I have had cataract surgery or don't have significant cataracts in the eye(s) to be treated.
Select...
My wet AMD is currently not active.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have high eye pressure or a history of glaucoma.
Select...
I have a corneal disease or disorder in either eye.
Select...
My entire central vision area in one or both eyes is affected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Best spectacle-corrected distance visual acuity (CDVA) changes from baseline to 24 months post-Tx
Secondary study objectives
Visual Function Questionnaire (VFQ)-25 quality of life assessment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

Optimal Acuity CorporationLead Sponsor
3 Previous Clinical Trials
111 Total Patients Enrolled
3 Trials studying Macular Degeneration
111 Patients Enrolled for Macular Degeneration
Bochner Eye InstituteUNKNOWN
1 Previous Clinical Trials
17 Total Patients Enrolled
1 Trials studying Macular Degeneration
17 Patients Enrolled for Macular Degeneration
Michael Berry, PhDStudy DirectorOptimal Acuity Corporation
3 Previous Clinical Trials
257 Total Patients Enrolled
2 Trials studying Macular Degeneration
57 Patients Enrolled for Macular Degeneration

Media Library

Optimal Acuity Clear-K® Low Vision Aid System (Low Vision Aid System) Clinical Trial Eligibility Overview. Trial Name: NCT04268836 — N/A
Macular Degeneration Research Study Groups: Treatment arm
Macular Degeneration Clinical Trial 2023: Optimal Acuity Clear-K® Low Vision Aid System Highlights & Side Effects. Trial Name: NCT04268836 — N/A
Optimal Acuity Clear-K® Low Vision Aid System (Low Vision Aid System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04268836 — N/A
Macular Degeneration Patient Testimony for trial: Trial Name: NCT04268836 — N/A
~109 spots leftby Nov 2025
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