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Not yet recruitingNCT04268836AMDUpdated Mar 22, 2023

Vision Improvement for Patients With Age-Related Macular Degeneration

An interventional study of Optimal Acuity Clear-K® Low Vision Aid System treatment in Age-related Macular Degeneration, sponsored by Optimal Acuity Corporation. Not yet recruiting at 1 site in Canada. Open to participants aged 50 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-22.

Sponsored by Optimal Acuity Corporation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
50 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

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.

02

Conditions studied

  • Age-related Macular Degeneration

Keywords

  • dry AMD
  • wet AMD
  • neovascular AMD
  • age-related macular degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's planned enrollment of 200 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Optimal Acuity Corporation is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceOptimal 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Through study completion, an average of 2 years

Secondary outcomes

  1. Visual Function Questionnaire (VFQ)-25 quality of life assessment

    The VFQ-25 instrument will be used to assess patient quality of life measures.

    Time frame: Through study completion, an average of 2 years

07

Study locations

1 site
  • 1929 Bayview Ave., Suite 117
    Toronto, Ontario M4G 3E8, Canada
    • Samuel Markowitz, MD, FRCSC · Contact · snm1@rogers.com · 4165315425
    • Samuel N Markowitz, MD, FRCSC · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04268836
Lead sponsor
Optimal Acuity Corporation
Collaborators
Bochner Eye Institute
Responsible party
Sponsor
First posted
Feb 13, 2020
Start date
Jan 9, 2024 (estimated)
Primary completion
May 31, 2024 (estimated)
Completion
May 1, 2025 (estimated)
Last update
Mar 22, 2023

Study contacts

Michael Berry, PhD
Contact
mberry177@gmail.com
8318691384
Samuel Markowitz, MD, FRCSC
Contact
snm1@rogers.com
4165315425
Michael Berry, PhD
study director · Optimal Acuity Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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