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Vision Improvement for Patients With Age-Related Macular Degeneration (AMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04268836
Recruitment Status : Not yet recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
Bochner Eye Institute
Information provided by (Responsible Party):
Optimal Acuity Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Device: Optimal Acuity Clear-K® Low Vision Aid System treatment Not Applicable

Detailed Description:

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.

120 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, non-randomized, unmasked clinical study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vision Improvement for Patients With Age-Related Macular Degeneration
Estimated Study Start Date : March 30, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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




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


Secondary Outcome Measures :
  1. Visual Function Questionnaire (VFQ)-25 quality of life assessment [ Time Frame: Through study completion, an average of 2 years ]
    The VFQ-25 instrument will be used to assess patient quality of life measures.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or Female
  2. Any race
  3. Patient is at least 50 years old.
  4. 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.
  5. Wet AMD eyes should have an inactive disease state (i.e., there is no clinical or OCT evidence of wet AMD disease activity).
  6. Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated..
  7. Patient has manifest refraction, spherical equivalent (MRSE) between -1.50 D to 1.50 D in eye(s) to be treated.
  8. 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.
  9. Patient has CDVA of 20/400 or better (decimal = 0.05 or greater; logMAR ≤ 1.30) in the worse eye.
  10. Patient has normal corneal surface topography on videokeratography (i.e., without distorted or unclear corneal mires) in both eyes.
  11. Patient is not a contact lens (CL) wearer.
  12. Patient is willing and able to comply with all examinations.
  13. Patient must be competent to sign an informed consent form before study entry.

Exclusion Criteria:

  1. Corneal disease or disorder in either eye;
  2. Corneal topographic astigmatism greater than 2.00 D (mean value within 3.0 mm optical zone);
  3. 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);
  4. Potential Visual Acuity (PVA) in both eyes that is not improved by at least three lines compared to CDVA;
  5. Increased intraocular pressure (above 20 mm Hg), glaucoma or history of glaucoma; and
  6. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268836


Contacts
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Contact: Michael Berry, PhD 8318691384 mberry177@gmail.com
Contact: Samuel Markowitz, MD, FRCSC 4168181229 snm1@rogers.com

Locations
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Canada, Ontario
Canadian National Institute for the Blind
Toronto, Ontario, Canada, M4G 3E8
Contact: Samuel Markowitz, MD, FRCSC    4168181229    snm1@rogers.com   
Principal Investigator: Samuel N Markowitz, MD, FRCSC         
Sponsors and Collaborators
Optimal Acuity Corporation
Bochner Eye Institute
Investigators
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Study Director: Michael Berry, PhD Optimal Acuity Corporation
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Responsible Party: Optimal Acuity Corporation
ClinicalTrials.gov Identifier: NCT04268836    
Other Study ID Numbers: OAC #001
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Optimal Acuity Corporation:
dry AMD
wet AMD
neovascular AMD
age-related macular degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases