Clinical Study to Evaluate Effectiveness of Digital Refraction
Completed · Not applicable
Conditions studied: Myopia, Astigmatism
In brief
Prospective, comparative, randomized, non-masked clinical study to compare the a digital refraction with LogMAR VA testing utilizing trial lenses, to standard manual refraction using a Phoropter, and LogMAR VA testing, in accuracy of visual acuity measurement.
Key facts
- Study ID
- NCT03502863
- Run by
- Visibly
- People needed
- 102
- Starts
- 2018-04-19
- Expected to finish
- 2018-07-06
- Last updated by the study team
- 2018-10-26
Who can join
Age: 22 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subject must be between 22 and 55 years of age at the time of consent.
- Subject must have a refractive error
- With no greater than -3.00 D myopia and -2.00 D astigmatism in either eye.
- With prior correction of no greater than -10.00 D myopia and requiring over-refraction of no more than 2.75 D in either eye.
- Subjects with Best Corrected Visual Acuity (BCVA) of 20/32 or better.
You may not qualify if…
- Subjects with diabetes mellitus.
- Subjects using ophthalmic or systemic corticosteroids.
- Subjects with autoimmune conditions.
- Subjects with active corneal or conjunctival infection.
- Subjects with active corneal, conjunctival, or intraocular inflammation (ie, uveitis).
- Subjects with diabetic retinopathy.
- Subjects with glaucoma or ocular hypertension.
- Subjects with macular degeneration.
- Subjects with previous ocular surgery.
- Subjects on antihyperglycemic agents; corticosteroids; hydroxychloroquine (Plaquenil) and chloroquine (Aralen); tamoxifen (Nolvadex).
- Pregnancy
- Subjects who, in the judgment of the Investigator, may be inappropriate for the intended study procedures.
Where it is running
- Site 03 — Fort Lauderdale, Florida, United States
- Site 02 — Nashville, Tennessee, United States
- Site 01 — Harlingen, Texas, United States
Full record on ClinicalTrials.gov
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