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The Effects of Low Dose Atropine on Choroidal Thickness

NCT03544827 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-02-15

No results posted yet for this study

Summary

Atropine eye drops are considered to be an effective form of myopia control in human eyes. However, the mechanism by which it exerts it effects are not fully understood. Thickening of the choroid subsequent to atropine administration may play an important role in the mechanisms by which atropine induces myopia control. Literature also notes that choroidal thickness undergoes diurnal variations, which is a variable that will be controlled in this study in order to examine atropine's effects on different baseline choroidal thicknesses.

The purpose of the proposed study is to characterize better the influence of atropine on choroid thickness. The study aims are to:

1. Determine the effect of low dose concentration of topical atropine (0.1% and 0.01%) on choroid thickness
2. Determine the effect of topical atropine on choroid thickness in relationship to baseline thickness throughout the day and after one week of daily instillation

Hypothesis: Atropine's effect on choroidal thickness will be dependent on the subject's baseline thickness measurements, at a designated time of the day when the choroid is at its thinnest.

Conditions

  • Myopia

Interventions

DRUG

Atropine

Atropine 0.01% then atropine 0.1%

DRUG

Atropine

Atropine 0.1% then atropine 0.01%

Sponsors & Collaborators

  • State University of New York College of Optometry

    lead OTHER

Principal Investigators

  • Alexandra Benavente-Perez, PhD · State University of New York College of Optometry

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-21
Primary Completion
2019-02-08
Completion
2019-02-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03544827 on ClinicalTrials.gov