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Completed

NCT Number: NCT04349254

Observational Study of Vision Improvement in Late Stage Dry AMD Patients

The purpose of this study is to assess the vision improvement achieved by patients with late stage dry age-related macular degeneration 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 late stage dry age-related macular degeneration who received corneal treatments by a low vision aid device. Patient records for patients with at least 12 months follow-up will be analyzed to determine measures of vision improvement including best spectacle-corrected distance and near visual acuity. 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

  • - Male or female
  • - Any race
  • - Patient is at least 50 years old
  • - Patient has diagnosed late stage dry age-related macular degeneration in one or both eyes.
  • - Treated eyes were pseudophakic at the time of treatment.
  • - Patient had moderate to severe baseline vision impairment with best spectacle-corrected distance visual acuity (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 12 month post-treatment.

Exclusion criteria

  • - Corneal disease or disorder in either eye.
  • - Increased intraocular pressure (above 20 mm Hg), glaucoma or history of glaucoma.
  • - 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 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.

Primary outcomes

  1. CDVA

    Time frame: 12 months

    Best spectacle-corrected distance visual acuity (CDVA)

Secondary outcomes

  1. CNVA

    Time frame: 12 months

    Best spectacle-corrected near visual acuity (CNVA)

Sponsors and collaborators

Lead sponsor

Optimal Acuity Corporation

Industry

Collaborators

  • Bochner Eye Institute

Registry information

Official study title

Observational Study of Vision Improvement in Late Stage Dry AMD Patients by a Low Vision Aid Device

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2020
Registry last updated
Feb 24, 2021

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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