Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults

July 26, 2024 updated by: Shanghai Eye Disease Prevention and Treatment Center

The Effectiveness and Acceptability of Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults: A Randomized Controlled Trial

This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

It has long been believed that the progression of myopia mainly occurs during the elementary to high school stages. However, some studies and clinical practice suggest that a considerable proportion of adults still experience myopia progression in their adulthood, especially in those who have prolonged near work or screen usage time. At present, there is insufficient evidence on whether these population needs myopia control intervention. Most adults experiencing myopia progression do not receive appropriate myopic intervention measures, leading to an increase of dioptre, which may affect the quality of daily life, and raise the risk of high myopia and blinding myopia complications.

This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.

Study Type

Interventional

Enrollment (Estimated)

144

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 Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200041
        • Shanghai Eye Disease Prevention & Treatment Center
        • Contact:
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-25 years;
  • Myopia progression <= -0.50D in either eye in the past year (evaluated by -manifest refraction);
  • The subject eye: cycloplegic spherical equivalent ranges from -2.00D to -6.0D and cylinder power doesn't exceed -1.50D;
  • The subject eye's best corrected visual acuity <= logMAR 0.1;
  • Anisometropia does not exceed 1.50D.

Exclusion Criteria:

  • Current use of MC interventions or prior use of MC interventions within the past 6 months;
  • Disease or anatomical factors that affect the wearing of contact lenses;
  • History of myopia correction surgery;
  • Suffering from ocular or systemic diseases that may be related to myopia, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.;
  • pregnant female;
  • Other conditions deemed unsuitable by the investigators.

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: Dual-focus CL
Wearing dual-focus CL for 2 years
Device: MiSight® 1 day soft contact lenses
Dual-focus contact lenses, daily disposable, material: omafilcon A, water content: 60%.
Other Names:
  • CooperVision
Placebo Comparator: Single-vision CL
Wearing single-vision CL for 2 years
Device: Proclear® 1 day soft contact lenses
Single-vision contact lenses, daily disposable, material: omafilcon A, water content: 60%.
Other Names:
  • CooperVision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cycloplegic spherical equivalent after 2 years
Time Frame: 2 years after the baseline
The difference in the change of cycloplegic spherical equivalent between the intervention group and the control group.
2 years after the baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in axial length after 2 years
Time Frame: 2 years after the baseline
The difference in the change of axial length between the intervention group and the control group.
2 years after the baseline

Collaborators and Investigators

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

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Investigators

  • Principal Investigator: Xiangui He, Shanghai Eye Disease Prevention & Treatment Center

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 (Estimated)

August 31, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

July 26, 2024

First Submitted That Met QC Criteria

July 26, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 26, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QX-2024-A-002

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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