Comparing Myopia Treatments in Youth: Defocus Spectacles, Glasses, and Ortho-K

February 19, 2024 updated by: He Eye Hospital

A Comparative Study on the Clinical Efficacy, Quality of Life, and Cost of Use of Peripheral Defocus Spectacles, Frame Glasses, and Orthokeratology Lenses in Myopic Children and Adolescents

The research project titled "A Comparative Study on the Clinical Efficacy, Quality of Life, and Cost of Use of Peripheral Defocus Spectacles, Frame Glasses, and Orthokeratology Lenses in Myopic Children and Adolescents" aims to evaluate different non-surgical myopia correction methods in children. It focuses on assessing the impact of peripheral defocus spectacles, frame glasses, and orthokeratology lenses on the quality of life, clinical effectiveness, and costs associated with each method. The study is a prospective cohort study involving 300 children aged 13-17 years with myopia ranging from -1.00D to -6.00D. It aims to compare the psychological, social, and educational aspects of these correction methods, alongside their costs and clinical outcomes over a period of one year.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The research project "Comparison of the clinical effect, quality of life and cost of using defocusing glasses, frame glasses and orthokeratology glasses in children and adolescents with myopia" aims to explore the impact of different myopia correction methods on children and adolescents. Myopia is one of the most common eye diseases in the world, especially in East Asia, where the incidence of myopia is extremely high. With the development of China's economy and the increasing pressure of children's education, the problem of myopia is becoming more and more serious, and parents and teenagers lack sufficient information and evidence for choosing the most suitable correction methods.

This study will compare the defocus frame glasses, ordinary monopteral frame glasses and orthokeratology glasses. The defocusing frame glasses are a new correction method, showing potential in controlling the length of the eye axis. Ordinary single-frame glasses are the most commonly used and economical choice; The orthokeratology lens is a kind of hard contact lens worn at night, which is in fast growing demand in the Chinese market.

The main objectives of the study include:

Quality of life assessment: To explore the impact of different correction methods on adolescents' daily life, learning, movement, appearance, mental health and social activities.

Use cost analysis: Compare the purchase cost, maintenance cost and replacement frequency of defocusing frame glasses, monopter frame glasses and orthokeratology glasses to assess the economic burden of long-term use.

In addition, the study will comprehensively evaluate the differences in clinical effectiveness, quality of life and cost of use of these correction methods, providing parents and adolescents with more comprehensive and objective information to help them make more informed choices.

Study Type

Observational

Enrollment (Estimated)

300

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
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • HeEyeHospital
        • 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

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population comprises children and adolescents aged 13-17 years with myopia ranging from -1.00D to -6.00D and astigmatism less than ±1.5D. Participants are first-time wearers of either peripheral defocus spectacles, single-vision frame glasses, or orthokeratology lenses. They are willing and able to complete all study requirements, including examinations, surveys, and cost recordings, and can maintain contact throughout the study duration with a stable address and contact information.

Description

Inclusion Criteria:

  • Children aged 13-17 years.
  • Myopia between -1.00D and -6.00D; astigmatism <±1.5D; best corrected visual acuity ≥1.0.
  • No prior use of peripheral defocus spectacles, single-vision frame glasses, or orthokeratology lenses (meaning first-time wearers).
  • Willingness to participate in the entire study process, completing all examinations, surveys, and cost recordings as required.
  • Ability to maintain contact throughout the study, with a fixed address and contact information.

Exclusion Criteria:

  • Other eye conditions: history of strabismus, amblyopia, anisometropia, fundus diseases, dry eye, etc.
  • Allergies: history of allergies to certain materials or medications.
  • Surgical history: recent eye surgery.
  • Non-compliance with required wear, follow-up, or lack of cooperation.
  • Severe psychological disorders or behavioral problems.

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

Cohorts and Interventions

Group / Cohort
Control Group1
This group includes children and adolescents who are correcting myopia using peripheral defocus spectacles. These spectacles are a novel corrective measure, designed to control myopia progression by creating a defocus zone around the periphery of the lenses.
Control Group2
This group consists of children and adolescents using orthokeratology lenses for myopia correction. Orthokeratology lenses are specially designed rigid contact lenses worn overnight to temporarily reshape the cornea, aiming to reduce dependency on glasses or contact lenses during the day.
Control Group3
This group includes children and adolescents who are using standard single-vision frame glasses for myopia correction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Quality of Life Scores
Time Frame: 1-Month Follow-up,3-Month Follow-up,6-Month Follow-up,12-Month Follow-up
Improvement in Quality of Life Scores: The study will assess the impact of peripheral defocus spectacles, regular frame glasses, and orthokeratology lenses on the improvement of quality of life in myopic children and adolescents. This will be measured using the 'Pediatric Vision-Related Quality of Life Questionnaire' at baseline, 12 months post-treatment to evaluate and compare the long-term effects of these correction methods on quality of life."
1-Month Follow-up,3-Month Follow-up,6-Month Follow-up,12-Month Follow-up
Cost-Effectiveness Analysis
Time Frame: 1-Month Follow-up,3-Month Follow-up,6-Month Follow-up,12-Month Follow-up
Cost-Effectiveness Analysis: This secondary outcome will assess the cost-effectiveness of peripheral defocus spectacles, regular frame glasses, and orthokeratology lenses in treating myopia in children and adolescents. The analysis will include the costs of acquiring, maintaining, and replacing these vision correction methods over a period of 12 months. This evaluation aims to provide a comprehensive financial comparison of these methods in terms of long-term expenditure and effectiveness in myopia management.
1-Month Follow-up,3-Month Follow-up,6-Month Follow-up,12-Month Follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Effectiveness Analysis
Time Frame: Baseline,1-Month Follow-up,3-Month Follow-up,6-Month Follow-up,12-Month Follow-up
"Clinical Effectiveness Analysis: The study will evaluate the differences in vision correction effectiveness among peripheral defocus spectacles, regular frame glasses, and orthokeratology lenses in myopic children and adolescents. This includes vision tests (such as standard visual acuity charts) and ocular assessments to measure changes in axial length. These evaluations will be conducted at baseline, 6 months, and 12 months post-treatment to compare and analyze the clinical effectiveness of the various correction methods.
Baseline,1-Month Follow-up,3-Month Follow-up,6-Month Follow-up,12-Month Follow-up

Collaborators and Investigators

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

Sponsor

He Eye Hospital

Investigators

  • Principal Investigator: ruyi Li, He 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)

November 10, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDSFGOCLMC-2023-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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