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

NCT06278974 | Recruiting

• 1 other identifier: PDSFGOCLMC-2023-001
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cost-effectiveness Analysis; Quality of Life; Myopia

Keywords

Myopia; youth; glasses

Outcome Measures

Primary Outcomes (2)

• Improvement in Quality of Life Scores

  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,6-Month Follow-up,12-Month Follow-up

• Cost-Effectiveness Analysis

  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.

  6-Month Follow-up,12-Month Follow-up

Secondary Outcomes (1)

• Clinical Effectiveness Analysis

  Baseline,6-Month Follow-up,12-Month Follow-up

Study Arms (3)

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.

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises children and adolescents aged 7-17 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• He Eye Hospital: lead

Study Sites (1)

HeEyeHospital

Shenyang, Liaoning, 110000, China

RECRUITING

Related Publications (13)

• Fricke TR, Jong M, Naidoo KS, Sankaridurg P, Naduvilath TJ, Ho SM, Wong TY, Resnikoff S. Global prevalence of visual impairment associated with myopic macular degeneration and temporal trends from 2000 through 2050: systematic review, meta-analysis and modelling. Br J Ophthalmol. 2018 Jul;102(7):855-862. doi: 10.1136/bjophthalmol-2017-311266. Epub 2018 Apr 26.

  PMID: 29699985 BACKGROUND

• Ma Y, Qu X, Zhu X, Xu X, Zhu J, Sankaridurg P, Lin S, Lu L, Zhao R, Wang L, Shi H, Tan H, You X, Yuan H, Sun S, Wang M, He X, Zou H, Congdon N. Age-Specific Prevalence of Visual Impairment and Refractive Error in Children Aged 3-10 Years in Shanghai, China. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6188-6196. doi: 10.1167/iovs.16-20243.

  PMID: 27842160 BACKGROUND

• Pan CW, Ramamurthy D, Saw SM. Worldwide prevalence and risk factors for myopia. Ophthalmic Physiol Opt. 2012 Jan;32(1):3-16. doi: 10.1111/j.1475-1313.2011.00884.x.

  PMID: 22150586 BACKGROUND

• Pan CW, Wu RK, Li J, Zhong H. Low prevalence of myopia among school children in rural China. BMC Ophthalmol. 2018 Jun 11;18(1):140. doi: 10.1186/s12886-018-0808-0.

  PMID: 29890943 BACKGROUND

• Dolgin E. The myopia boom. Nature. 2015 Mar 19;519(7543):276-8. doi: 10.1038/519276a. No abstract available.

  PMID: 25788077 BACKGROUND

• Li Y, Liu J, Qi P. The increasing prevalence of myopia in junior high school students in the Haidian District of Beijing, China: a 10-year population-based survey. BMC Ophthalmol. 2017 Jun 12;17(1):88. doi: 10.1186/s12886-017-0483-6.

  PMID: 28606071 BACKGROUND

• Wang J, Ying GS, Fu X, Zhang R, Meng J, Gu F, Li J. Prevalence of myopia and vision impairment in school students in Eastern China. BMC Ophthalmol. 2020 Jan 2;20(1):2. doi: 10.1186/s12886-019-1281-0.

  PMID: 31898504 BACKGROUND

• Wu PC, Huang HM, Yu HJ, Fang PC, Chen CT. Epidemiology of Myopia. Asia Pac J Ophthalmol (Phila). 2016 Nov/Dec;5(6):386-393. doi: 10.1097/APO.0000000000000236.

  PMID: 27898441 BACKGROUND

• Ma JX, Tian SW, Liu QP. Effectiveness of peripheral defocus spectacle lenses in myopia control: a Meta-analysis and systematic review. Int J Ophthalmol. 2022 Oct 18;15(10):1699-1706. doi: 10.18240/ijo.2022.10.20. eCollection 2022.

  PMID: 36262865 BACKGROUND

• Yang T, Hu R, Tian W, Lin Y, Lu Y, Liang X, Zheng D, Zhang X. Comparison of Functional Vision and Eye-Related Quality of Life between Myopic Children Treated with Orthokeratology and Single-Vision Spectacles in Southern China. J Ophthalmol. 2023 Apr 8;2023:7437935. doi: 10.1155/2023/7437935. eCollection 2023.

  PMID: 37089412 BACKGROUND

• Yang B, Ma X, Liu L, Cho P. Vision-related quality of life of Chinese children undergoing orthokeratology treatment compared to single vision spectacles. Cont Lens Anterior Eye. 2021 Aug;44(4):101350. doi: 10.1016/j.clae.2020.07.001. Epub 2020 Jul 13.

  PMID: 32674999 BACKGROUND

• Walline JJ, Gaume A, Jones LA, Rah MJ, Manny RE, Berntsen DA, Chitkara M, Kim A, Quinn N. Benefits of contact lens wear for children and teens. Eye Contact Lens. 2007 Nov;33(6 Pt 1):317-21. doi: 10.1097/ICL.0b013e31804f80fb.

  PMID: 17993828 BACKGROUND

• Walline JJ, Bailey MD, Zadnik K. Vision-specific quality of life and modes of refractive error correction. Optom Vis Sci. 2000 Dec;77(12):648-52. doi: 10.1097/00006324-200012000-00011.

  PMID: 11147734 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• ruyi Li

  He Eye Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

lan Hu

CONTACT

+8615940406919; hulan@hsyk.com.cn

ruyi Li

CONTACT

+8615754717553; liruyi202202@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: November 10, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)