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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
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 belowSelect...
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.
Select...
I have severe vision loss from dry age-related macular degeneration.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
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
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
Bochner Eye InstituteUNKNOWN
1 Previous Clinical Trials
17 Total Patients Enrolled
Michael Berry, PhDStudy DirectorOptimal Acuity Corporation
2 Previous Clinical Trials
57 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 50 years old or older.You do not wear contact lenses.I am either male or female.I have high eye pressure or a history of glaucoma.I am mentally capable of understanding and signing the consent form.My best vision with glasses is 20/80 or worse due to dry AMD.I have had cataract surgery or don't have significant cataracts in the eye(s) to be treated.I am mentally capable of understanding and signing the consent form.I have severe vision loss from dry age-related macular degeneration.My wet AMD is currently not active.I am 50 years old or older.I have been diagnosed with age-related macular degeneration in at least one eye.I have been diagnosed with age-related macular degeneration in at least one eye.I have had cataract surgery or don't have significant cataracts in the eye(s) to be treated.I have a corneal disease or disorder in either eye.My entire central vision area in one or both eyes is affected.My wet AMD is currently not active.The patient has a manifest refraction of between -1.50 D and 1.50 D in the eye(s) to be treated.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Age-Related Macular Degeneration Patient Testimony for trial: Trial Name: NCT04268836 — N/A
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