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NCT Number: NCT06278974

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

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 90 children aged 8-17 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.

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Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HeEyeHospital

Shenyang, Liaoning, 110000, China

Location status: Recruiting

Location contact

Lan Hu, Master

CONTACT

[email protected]

15940406919

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 7-17 years.
  • Myopia between -1.00D and -6.00D; astigmatism <±1.5D; best corrected visual acuity ≥1.0.
  • First-time spectacle wearers who use a single correction method and meet the indications for it (any one of orthokeratology lenses, single-vision frame glasses, or myopia control frame glasses)
  • Willing to participate in the entire research process and complete all the examinations, questionnaires and cost records as required.
  • Be able to maintain contact throughout the research period, such as having a fixed address and contact information.

Exclusion criteria

  • History of strabismus, amblyopia, refractive disparity or retinal diseases
  • Previous history of eye surgery
  • Severe psychological disorders or behavioral problems
  • History of allergy to contact lenses or contact lens care solutions

Treatment and study plan

Primary outcomes

  1. Improvement in Quality of Life Scores

    Time frame: 1-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."

  2. Cost-Effectiveness Analysis

    Time frame: 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.

Secondary outcomes

  1. Clinical Effectiveness Analysis

    Time frame: Baseline,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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

He Eye Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 26, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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