Eye Drops Study for Myopia Control in Schoolchildren

January 16, 2018 updated by: Chang Gung Memorial Hospital
The myopia prevalence in schoolchildren is high in Taiwan. The myopia progression is fast in children and often associated high myopia in later life. This prospective and randomized study to investigate the effect of myopia control in myopic children with ultra low concentrations of atropine eye drops and/or low concentrations of anti-allergic and inflammatory eye drops.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Myopia onset earlier in children who would suffer a high degree of myopia in the future adulthood.and higher risk for retinal detachment, macular degeneration, and even blindness. In Taiwan, myopia macular degeneration is the first place of irreversible blind cause in the elderly. The evidence based medicine shows atropine is the most effective treatment for the progression of myopia so far, but the side effects including photophobia and near blurred vision often disturbing patients and resulting poor compliance and high drop-out rate.

Recently, the studies from Taiwan and Singapore showed that low concentrations of atropine (0.05% or 0.01%) can effectively inhibit the myopia progression, reduce the symptoms of photophobia, and to achieve favorable myopia control. Previous study found that myopia and allergic conjunctivitis and inflammation were related. The investigators designed a prospective and randomized study to investigate the effect of myopia control in myopic children with ultra low concentrations of atropine eye drops and/or low concentrations of anti-allergic and inflammatory eye drops. Due to environmental factors such as near work, after school class and outdoor activity are also great associated with myopia, the questionnaires also are collected in this study.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:
          • Pei-Chang Wu, MD

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

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Myopia diagnosed with the spherical equivalent refraction at least -0.5 diopter (D)
  • Must be able to use eye drops

Exclusion Criteria:

  • astigmatism -1.50 D or greater
  • strabismus
  • amblyopia
  • cataract
  • glaucoma
  • any ocular diseases ocular surgery
  • history of systemic diseases (ex. asthma, heart disease...)
  • contact lenses user
  • orthokeratology user

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.01% atropine
children who received 0.01% atropine for myopia
Drug: eye drops
children who received daily eye drops for myopia
Experimental: 0.005% atropine
children who received 0.005% atropine for myopia
Drug: eye drops
children who received daily eye drops for myopia
Experimental: 0.25% Ketorolac
children who received 0.25% Ketorolac for myopia
Drug: eye drops
children who received daily eye drops for myopia
Experimental: 0.01% atropine plus 0.25% Ketorolac
children who received 0.01% atropine plus 0.25% Ketorolac for myopia
Drug: eye drops
children who received daily eye drops for myopia
Experimental: 0.005% atropine plus 0.25% Ketorolac
children who received 0.005% atropine plus 0.25% Ketorolac for myopia
Drug: eye drops
children who received daily eye drops for myopia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cycloplegic spherical refraction change measured by auto-refractometer (Diopter)
Time Frame: 1 year
Cycloplegic spherical refraction change measured by auto-refractometer (Diopter) is the main indicator of the myopia progression.
1 year
Axial length change (mm) measured by non-contact biometry
Time Frame: 1 year
Axial length change (mm) measured by non-contact biometry is another indicator of the myopia progression.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure (mmHg) by non-contact tonometer
Time Frame: 1 year
measures Intraocular pressure (mmHg) by non-contact tonometer
1 year
Accommodation (diopter) by accommodometer
Time Frame: 1 year
Accommodation change (diopter) by accommodometer is another indicator of the myopia progression.
1 year
Pupil size (mm) by electronic rule
Time Frame: 1 year
measures Pupil size (mm) by electronic rule
1 year
Anterior chamber depth (mm) measured by non-contact biometry
Time Frame: 1 year
measures Anterior chamber depth (mm) measured by non-contact biometry
1 year
Posterior chamber depth (mm) measured by non-contact biometry
Time Frame: 1 year
measures Posterior chamber depth (mm) measured by non-contact biometry
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire
Time Frame: 1 year
Record by patients and their parents about how many hours per week of near work (ex. computer/video game,cell phone,reading, piano playing...) and outdoor activities, the compliance of atropine use, discomfort after atropine use (ex. photophobia or blurred vision when near work)
1 year

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Pei-Chang Wu, MD, No.123,DAPI Rd. Niaosong Dist, Kaohsiung City 83301 Taiwan, R.O.C.

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)

October 20, 2014

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

January 4, 2018

First Submitted That Met QC Criteria

January 16, 2018

First Posted (Actual)

January 18, 2018

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103-3476A3

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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