The Influence of Atropine on Choroidal Thickness

NCT ID: NCT03158142

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-15
• Study Completion Date: 2017-11-20

Brief Summary

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 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.

Detailed Description

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:

1. Determine the effect of am or pm atropine application on choroid thickness

2. 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.

Conditions

Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Atropine group

One drop of Atropine Sulfate 1% Oph Soln will be administered either in the morning or at night in each eye. Study measurements will be taken approximately after 1, 12, 24 and 96 hours after drop instillation. After a 2 week wash out period with no eye drops, another drop of 1% atropine sulfate ophthalmic eye drops will be administered either in the morning or night (the visit that was not taken before) and study measurements will be scheduled approximately after 1, 12 24 and 96 hours after drop instillation

Group Type: EXPERIMENTAL

Atropine Sulfate 1% Oph Soln

Intervention Type: DRUG

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

Interventions

Atropine Sulfate 1% Oph Soln

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

Intervention Type: DRUG

Other Intervention Names

1% atropine eye drops

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of New South Wales

OTHER

Sponsor Role: collaborator

State University of New York College of Optometry

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

State University of New York College of Optometry

New York, New York, United States

Countries

United States

Other Identifiers

1000533-1

Identifier Type: -

Identifier Source: org_study_id