Short Term Refractive and Ocular Parameter Changes After Topical Atropine

February 11, 2019 updated by: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
In order we had designed a prospective clinical trial. Spherical equivalent refractive error (SER), axial length (AL), mean keratometric value (Mean-K), anterior chamber depth (ACD), and intraocular pressure (IOP) were measured at baseline and one week after topical use of 0.125% atropine. Postcycloplegic changes of refractive error and ocular parameters were evaluated, and their correlations were analyzed with multiple linear regression models.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who had an SER of -0.5 diopters or less in their eyes.

Exclusion Criteria:

  • Patients who had already been undergoing cycloplegic treatment for myopia before.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 0.125% atropine group
patients used the 0.125 % atropine eyedrop every night before sleep for 7 days
Drug: 0.125% Atropine
patients used 0.125% atropine eyedrop per night before sleep for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SER
Time Frame: change from SER at 7 days
Spherical equivalent refractive error
change from SER at 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AL
Time Frame: change from AL at 7 days
Axial length
change from AL at 7 days
ACD
Time Frame: change from ACD at 7 days
anterior chamber depth
change from ACD at 7 days
IOP
Time Frame: change from IOP at 7 days
intraocular pressure
change from IOP at 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

December 31, 2015

Study Completion (ACTUAL)

December 31, 2015

Study Registration Dates

First Submitted

February 10, 2019

First Submitted That Met QC Criteria

February 11, 2019

First Posted (ACTUAL)

February 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BuddhistTCGHTaipei2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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