The Influence of Atropine on Choroidal Thickness

NCT03158142 | Completed Phase 4 FDA Drug

• 1 other identifier: 1000533-1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Choroidal thickness

  Change in choroidal thickness after atropine

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

Study Arms (1)

Atropine group

EXPERIMENTAL

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

Drug: Atropine Sulfate 1% Oph Soln

Interventions

Atropine Sulfate 1% Oph Soln DRUG

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

Also known as: 1% atropine eye drops

Atropine group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• State University of New York College of Optometry: lead
• The University of New South Wales: collaborator

Study Sites (1)

State University of New York College of Optometry

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 17, 2017
• Study Start: March 15, 2017
• Primary Completion: November 20, 2017
• Study Completion: November 20, 2017
• Last Updated: October 15, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)