Assess the Effects of Spectacles or Orthokeratology on Dry Eye Parameters in Children and Adolescents.
NCT ID: NCT06023108
Last Updated: 2023-09-13
Study Results
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Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2023-11-23
2024-01-30
Brief Summary
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Detailed Description
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In recent years, the prevalence of myopia has significantly increased nationwide, The incidence rate of myopia among adolescents in China has risen significantly, causing blurred vision. Severe myopia can cause complications that threaten vision, such as glaucoma and macula disease. It would be highly undesirable to increase the social burden. Myopia can be corrected by orthokeratology (OK) and spectacles. It has been shown in numerous researches that orthokeratology lens are recognized as one of the effective methods in the treatment of myopia, has been widely used nationwide. In current years, the clinical treatment of myopia by OK lens in adolescents are increasingly confirmed to prevent the progression. Traditional OK lenses change refractive power by reshaping the corneal Epithelium (leading to the redistribution of corneal epithelium). As the overnight OK lens directly contact the ocular surface, the patients may endure symptoms and signs of dry eye disease (DED), which may even have some impact on the health of the ocular surface, including potential complications such as Keratitis. In addition, corneal staining often has occurred in ook wearers. According to previous studies, it has shown that wearing contact lens will affect the tear film stability, damage the function of the meibomian gland, tear film thinning, its affect ocular inflammation. Recent studies have also shown that OK continuous wearing has the least impact at 12 months. In order to ensure the safety of long-term wearing ok lenses in children and adolescents, the effect of OK lens on tear film and meibomian gland demonstrated further exploration.
The aim of this study is to evaluate the effect of OK on the ocular surface and meibomian gland function in children and adolescents. To assess the effect of OK on ocular surface and meibomian gland function in children and adolescents, so as to improve the application of the clinical.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Orthokeratology group
Participants in OK lenses group will wear OK lenses at least 8 hours per day for 12 months.
Orthokeratology
OK lenses will be used to evaluate the condition that causes dry eye in the treatment of myopia.
Spectacles group
Participants in spectacles group will wear per day for 12 months.
Spectacles
Spectacles will be used to evaluate the condition that causes dry eye in the treatment of myopia.
Interventions
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Orthokeratology
OK lenses will be used to evaluate the condition that causes dry eye in the treatment of myopia.
Spectacles
Spectacles will be used to evaluate the condition that causes dry eye in the treatment of myopia.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
8 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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Emmanuel Eric E Pazo, PHD
Role: STUDY_CHAIR
He Eye Hospital, Shenyang, China
Locations
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He Eye Hospital
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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Tao Z, Wang J, Zhu M, Lin Z, Zhao J, Tang Y, Deng H. Does Orthokeratology Wearing Affect the Tear Quality of Children? Front Pediatr. 2022 Jan 18;9:773484. doi: 10.3389/fped.2021.773484. eCollection 2021.
Hui W, Xiao-Feng H, Song-Guo L, Jing-Jing W, Xuan H, Yong T. Application of orthokeratology on myopia control and its effect on ocular surface and meibomian gland function in Chinese myopic adolescents. Front Med (Lausanne). 2022 Dec 8;9:979334. doi: 10.3389/fmed.2022.979334. eCollection 2022.
Yan ZP. Dry eye symptoms and signs in children wearing OK lenses for six months in China. J Fr Ophtalmol. 2020 Mar;43(3):211-215. doi: 10.1016/j.jfo.2019.07.029. Epub 2020 Jan 27.
Fricke TR, Holden BA, Wilson DA, Schlenther G, Naidoo KS, Resnikoff S, Frick KD. Global cost of correcting vision impairment from uncorrected refractive error. Bull World Health Organ. 2012 Oct 1;90(10):728-38. doi: 10.2471/BLT.12.104034. Epub 2012 Jul 12.
Kakita T, Hiraoka T, Oshika T. Influence of overnight orthokeratology on axial elongation in childhood myopia. Invest Ophthalmol Vis Sci. 2011 Apr 6;52(5):2170-4. doi: 10.1167/iovs.10-5485.
He M, Du Y, Liu Q, Ren C, Liu J, Wang Q, Li L, Yu J. Effects of orthokeratology on the progression of low to moderate myopia in Chinese children. BMC Ophthalmol. 2016 Jul 27;16:126. doi: 10.1186/s12886-016-0302-5.
Nti AN, Berntsen DA. Optical changes and visual performance with orthokeratology. Clin Exp Optom. 2020 Jan;103(1):44-54. doi: 10.1111/cxo.12947. Epub 2019 Aug 4.
Wang X, Li J, Zhang R, Li N, Pang Y, Zhang Y, Wei R. The Influence of Overnight Orthokeratology on Ocular Surface and Meibomian Gland Dysfunction in Teenagers with Myopia. J Ophthalmol. 2019 Jan 21;2019:5142628. doi: 10.1155/2019/5142628. eCollection 2019.
Yang L, Zhang L, Jian Hu R, Yu PP, Jin X. The influence of overnight orthokeratology on ocular surface and dry eye-related cytokines IL-17A, IL-6, and PGE2 in children. Cont Lens Anterior Eye. 2021 Feb;44(1):81-88. doi: 10.1016/j.clae.2020.04.001. Epub 2020 Apr 30.
Yu H, Yuan Y, Wu W, Zeng W, Tong L, Zhang Y, Feng Y. Orthokeratology Lens Wear for 2 Years in Children Did Not Alter Tear Film Lipid Thickness by Non-Invasive Interferometry. Front Med (Lausanne). 2022 Feb 10;9:821106. doi: 10.3389/fmed.2022.821106. eCollection 2022.
Lee J, Hwang G, Ha M, Kim HS, Han K, Na KS. Evaluation of the meibomian glands using the tear interferometer wearing orthokeratology lenses. BMC Ophthalmol. 2022 Mar 24;22(1):133. doi: 10.1186/s12886-022-02365-3.
Song Y, Chen J, Qin G, Xu L, He W, Yu S, Pazo EE, He X. A protocol for a single center, randomized, controlled trial assessing the effects of spectacles or orthokeratology on dry eye parameters in children and adolescents. Heliyon. 2024 Sep 12;10(18):e37779. doi: 10.1016/j.heliyon.2024.e37779. eCollection 2024 Sep 30.
Other Identifiers
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orthokeratology 2023
Identifier Type: -
Identifier Source: org_study_id
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