Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia

December 25, 2022 updated by: Tianjin Eye Hospital

Muti-center Clinical Trial to Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia

Clinical trial to evaluate the safety and effectiveness of two kinds of ring band cylindrical lens in delaying the progression of myopia

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Two-hundered and forty children aged 6-13 will be recruited and allocated to three groups. Subjects that were randomized to receive Circular cylindrical mirror modulated frame glasses (compact), Circular cylindrical mirror modulated frame glasses (strong defocus) or single vision frame glasses, respectively.

Primary outcome measure ocular axial length and the secondary indicator is spherical equivalent after cycloplegia.

Study Type

Interventional

Enrollment (Actual)

240

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 Locations

  • China
      • Tianjin, China, 300020
        • Tianjin Eye Hospital

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

6 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 6-13 years old;
  2. SER: -0.75 to -5.00 dioptres (D). Astigmatism and anisometropia of 1.50 D or less;
  3. Monocular best corrected visual acuity (VA) of 1.0 or better;
  4. Acceptance of random group allocation and the masked study design
  5. Voluntarily participate in the clinical trial and sign the informed consent;

Exclusion Criteria:

  1. Strabismus.
  2. Ocular and systemic abnormalities.
  3. Prior experience of myopia control.
  4. Only one eye meets the inclusion criteria.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Circular cylindrical mirror modulated frame glasses (compact)
Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (compact) throughout the entire course of the study.
Device: Circular cylindrical mirror modulated frame glasses (compact)
Circular cylindrical mirror modulated frame glasses (compact)
Experimental: Circular cylindrical mirror modulated frame glasses (strong defocus)
Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (strong defocus) throughout the entire course of the study.
Device: Circular cylindrical mirror modulated frame glasses (strong defocus)
Circular cylindrical mirror modulated frame glasses (strong defocus)
Experimental: single vision frame glasses
Subjects that were randomized to receive the single vision frame glasses throughout the entire course of the study.
Device: single vision frame glasses
single vision frame glasses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in ocular axial length in a year
Time Frame: baseline, 12 months
The ocular axial length was measured by AL-scan
baseline, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in cycloplegic objective spherical equivalent in a year
Time Frame: baseline, 12 months
The cycloplegic objective spherical equivalent was evaluated by a autorefractor
baseline, 12 months

Collaborators and Investigators

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

Sponsor

Tianjin Eye Hospital

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)

May 1, 2022

Primary Completion (Anticipated)

October 15, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

February 10, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (Actual)

March 21, 2022

Study Record Updates

Last Update Posted (Actual)

December 28, 2022

Last Update Submitted That Met QC Criteria

December 25, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TianjinEH-myopia progression

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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