The Influence of Atropine on Choroidal Thickness

The aim of this study is to characterize the effects of atropine on choroidal thickness and the influence of time of administration (am vs pm). It is hypothesized that the atropine's effect on choroidal thickness will vary with baseline thickness related to diurnal rhythm, where thicker baseline thickness will show a reduced choroidal response.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

State University of New York College of Optometry

New York, 10036, United States

About this study

Atropine eye drops are increasingly prescribed for the management of progressive myopia or short-sightedness. A previous study suggested that the back of the eye or choroid may be a part of the mechanism by which it induces its effects. The choroid shows diurnal variation and the efficacy of atropine on myopia control in relationship to the patient's baseline choroidal thickness is unknown. Thus, the objective of this study is to provide data to characterize the influence of atropine on choroid thickness. The study aims are to:

Determine the effect of am or pm atropine application on choroid thickness
Determine the effect of atropine on choroid thickness in relationship to baseline thickness

Participants will be asked to attend a screening session and 13 study visits. Following the screening visit, participants will be scheduled to return for 4 visits across 12 hours (4 hour intervals starting from 8am) in a single day where eye shape measurements will be taken to characterize diurnal variations in eye shape.

Subjects will then be randomized to receive a drop of 1% atropine eye drops in both eyes in the morning or a night. Measurements of the shape of the front and back of the eye will be taken after approximately 1, 12, 24 and 96 hours after drop instillation. After a 2 week washout period, 1% atropine eye drops will be administered either in the morning or at night (the visit that was not previously scheduled) and measurements of the shape of the front and back of the eye will be taken after approximately 1, 12, 24 and 96 hours after drop instillation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Good general and ocular health
Soft contact lens wearers to cease lens wear for at least 24 hours
No previous rigid gas permeable lens wear

Exclusion criteria

History of ocular surgery, including refractive surgery
Amblyopia
Use of ocular medications
Known allergies or sensitivity to atropine
Pregnant, plan to become pregnant, or are breastfeeding
Taking monoamine oxidase inhibitors (MAOIs)

Treatment and study plan

Atropine Sulfate 1% Oph Soln

Drug

Atropine sulphate 1% ophthalmic solution is both a mydriatic and cycloplegic

Other names: 1% atropine eye drops

Primary outcomes

Choroidal thickness

Time frame: Baseline, then after approximately 1, 12, 24 and 96 hours after atropine instillation

Change in choroidal thickness after atropine

Sponsors and collaborators

Lead sponsor

State University of New York College of Optometry

Other

Collaborators

The University of New South Wales

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: May 17, 2017
Registry last updated: Oct 15, 2018

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.

Published trials that share one or more normalized conditions with this study.

Completed