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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

Tracking Information
First Submitted Date  ICMJE January 16, 2018
First Posted Date  ICMJE February 13, 2020
Last Update Posted Date February 13, 2020
Estimated Study Start Date  ICMJE March 30, 2020
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2020)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vision Improvement for Patients With Age-Related Macular Degeneration
Official Title  ICMJE Vision Improvement for Patients With Age-Related Macular Degeneration
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, non-randomized, unmasked clinical study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Age-related Macular Degeneration
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Treatment arm
Patients will be treated by the Optimal Acuity Clear-K Low Vision Aid System.
Intervention: Device: Optimal Acuity Clear-K® Low Vision Aid System treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 11, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Michael Berry, PhD 8318691384 mberry177@gmail.com
Contact: Samuel Markowitz, MD, FRCSC 4168181229 snm1@rogers.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04268836
Other Study ID Numbers  ICMJE OAC #001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Optimal Acuity Corporation
Study Sponsor  ICMJE Optimal Acuity Corporation
Collaborators  ICMJE Bochner Eye Institute
Investigators  ICMJE
Study Director: Michael Berry, PhD Optimal Acuity Corporation
PRS Account Optimal Acuity Corporation
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP