Comparing Myopia Treatments in Youth: Defocus Spectacles, Glasses, and Ortho-K
NCT ID: NCT06278974
Last Updated: 2024-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2023-11-10
2025-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Control Group3
This group includes children and adolescents who are using standard single-vision frame glasses for myopia correction.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
13 Years
17 Years
ALL
No
Sponsors
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He Eye Hospital
OTHER
Responsible Party
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Principal Investigators
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ruyi Li
Role: PRINCIPAL_INVESTIGATOR
He Eye Hospital
Locations
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HeEyeHospital
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Dolgin E. The myopia boom. Nature. 2015 Mar 19;519(7543):276-8. doi: 10.1038/519276a. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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PDSFGOCLMC-2023-001
Identifier Type: -
Identifier Source: org_study_id
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