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Observational Study of Vision Improvement in Late Stage Dry AMD Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04349254
Enrollment
17
Registered
2020-04-16
Start date
2020-08-14
Completion date
2020-12-31
Last updated
2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Age-related Macular Degeneration

Keywords

Dry AMD

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

Bochner Eye Institute
CollaboratorOTHER
Optimal Acuity Corporation
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

1. \- Male or female 2. \- Any race 3. \- Patient is at least 50 years old 4. \- Patient has diagnosed late stage dry age-related macular degeneration in one or both eyes. 5. \- Treated eyes were pseudophakic at the time of treatment. 6. \- 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). 7. \- Patient CDVA records are available at baseline and at 12 month post-treatment.

Exclusion criteria

1. \- Corneal disease or disorder in either eye. 2. \- Increased intraocular pressure (above 20 mm 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. \-

Design outcomes

Primary

MeasureTime frameDescription
CDVA12 monthsBest spectacle-corrected distance visual acuity (CDVA)

Secondary

MeasureTime frameDescription
CNVA12 monthsBest spectacle-corrected near visual acuity (CNVA)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026