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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
AMD Trial 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.Check my eligibility
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.See study design
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.
AMD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
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My best vision with glasses is 20/80 or worse due to dry AMD.
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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.
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I am 50 years old or older.
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I have been diagnosed with age-related macular degeneration in at least one eye.
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I have been diagnosed with age-related macular degeneration in at least one eye.
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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.
AMD Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best spectacle-corrected distance visual acuity (CDVA) changes from baseline to 24 months post-Tx
Secondary outcome measures
Visual Function Questionnaire (VFQ)-25 quality of life assessment
AMD 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the current enrollment open to additional participants?
"Per the data presented on clinicaltrials.gov, this research is no longer actively recruiting patients; it was first posted on May 1st 2022 and last updated April 18th 2022. Despite that, there are a wealth of other studies currently seeking participants - 160 in total."
Answered by AI
Does the study accept enrollees that are over 70 years old?
"This trial requires that all participating patients are aged between 50-100 as per the specified criteria."
Answered by AI
Could I qualify to join this research project?
"Eligibility for this study necessitates macular degeneration and a patient age between 50 to 100 years old. A total of 200 patients are expected to be enrolled in the trial."
Answered by AI
Who else is applying?
What state do they live in?
Ontario
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+
What site did they apply to?
1929 Bayview Ave., Suite 117
Why did patients apply to this trial?
I am told that there is no treatment for AMD and I am looking to be accepted for a clinical trial which is focused on treatment. I am looking to take preventative steps.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long with screening tests take? What are my chances of being accepted?
PatientReceived no prior treatments
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