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

Quality of Life Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06278974
• Other study ID #: PDSFGOCLMC-2023-001
• Status: Recruiting
• Start date: November 10, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: January 2024
• Source: He Eye Hospital
• Contact: lan Hu
• Phone: +8615940406919
• Email: hulan[@]hsyk.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cost-effectiveness Analysis
• Myopia
• Quality of Life

Locations

Country	Name	City	State
China	HeEyeHospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
He Eye Hospital

Country where clinical trial is conducted

China, 

References & Publications (13)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,3-Month Follow-up,6-Month Follow-up,12-Month Follow-up
Primary	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.	1-Month Follow-up,3-Month Follow-up,6-Month Follow-up,12-Month Follow-up
Secondary	Clinical Effectiveness Analysis	"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