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OpenTrials
Completed

NCT Number: NCT04693702

Observational Study of Vision Improvement in Patients With Retinal Disorders

The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders who received corneal treatments by a low vision aid device.

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Key information

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bochner Eye Institute

Toronto, Ontario, M5R 1A9, Canada

About this study

The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders, including age-related macular degeneration and diabetic macular edema, who received corneal treatments by a low vision aid device. Patient records will be analyzed to determine measures of vision improvement including best spectacle-corrected distance visual acuity (CDVA). Analyses will include descriptive statistics and correlation between outcomes and baseline characteristics.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - Female or male
  • - Any race
  • - Patient is at least 50 years old
  • - Patient has diagnosed retinal disorder that causes central vision loss in one or both eyes
  • - Treated eyes, at time of treatment, were pseudophakic or phakic with no significant vision loss due to cataract
  • - Patient had moderate to severe baseline vision impairment with CDVA of 20/63 or worse (decimal = 0.317 or less; logMAR greater than or equal to 0.50) in the treated eye(s)
  • - Patient CDVA records are available at baseline and at 1m or longer post-Tx times

Exclusion criteria

1 - Corneal disease or disorder in either eye 2 - Increased intraocular pressure (above 20mm Hg), glaucoma or history of glaucoma 3 - Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable for retrospective observational study

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Treatment and study plan

Corneal treatment by a low vision aid device

Device

Near infrared light is used to irradiate the cornea to change the modulus of small volumes of anterior stroma. The modulus change produces a change in light distribution onto the retina. Light rays are redirected from dysfunctional areas of the retina to functional areas, thereby improving patient vision.

Primary outcomes

  1. CDVA

    Time frame: 12 months

    Best spectacle-corrected distance visual acuity

Sponsors and collaborators

Lead sponsor

Optimal Acuity Corporation

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 5, 2021
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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