Vision Improvement for Patients With Age-Related Macular Degeneration

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Vision Improvement for Patients With Age-Related Macular Degeneration

Conditions
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Age-related Macular Degeneration

Intervention / Treatment
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* Device: Optimal Acuity Clear-K® Low Vision Aid System treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female Any race Patient is at least 50 years old. Patient has diagnosed dry or wet age-related macular degeneration in one or both eyes, as verified by a complete ocular examination by a retina specialist; the full ocular examination, including optical coherence tomography (OCT) measurements, should be part of the patient's file. Wet AMD eyes should have an inactive disease state (i.e., there is no clinical or OCT evidence of wet AMD disease activity). Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.. Patient has manifest refraction, spherical equivalent (MRSE) between -1.50 D to 1.50 D in eye(s) to be treated. 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. Patient has CDVA of 20/400 or better (decimal = 0.05 or greater; logMAR ≤ 1.30) in the worse eye. Patient has normal corneal surface topography on videokeratography (i.e., without distorted or unclear corneal mires) in both eyes. Patient is not a contact lens (CL) wearer. Patient is willing and able to comply with all examinations. Patient must be competent to sign an informed consent form before study entry. Exclusion Criteria: Corneal disease or disorder in either eye; Corneal topographic astigmatism greater than 2.00 D (mean value within 3.0 mm optical zone); Pathological retinal morphology in either eye that completely affects the entire 10° (3 mm diameter) of the retina centered on the foveola (as evaluated by optical coherence tomography); Potential Visual Acuity (PVA) in both eyes that is not improved by at least three lines compared to CDVA; Increased intraocular pressure (above 20 mm Hg), glaucoma or history of glaucoma; and Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or that may confound the outcome of the study.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, non-randomized, unmasked clinical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Patients will be treated by the Optimal Acuity Clear-K Low Vision Aid System. | Device: Optimal Acuity Clear-K® Low Vision Aid System treatment<br>* The treatment involves irradiation of the cornea with low energy light in a treatment pattern that produces corneal shape change.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best spectacle-corrected distance visual acuity (CDVA) changes from baseline to 24 months post-Tx | CDVA will be measured using ETDRS letter scoring both pre-Tx and post-Tx with follow-up to 24 months post-Tx | Through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Function Questionnaire (VFQ)-25 quality of life assessment | The VFQ-25 instrument will be used to assess patient quality of life measures. | Through study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry AMD, wet AMD, neovascular AMD, age-related macular degeneration