Assess the Effects of Spectacles or Orthokeratology on Dry Eye Parameters in Children and Adolescents.

Study Overview
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Brief Summary
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Orthokeratology(OK) is currently one of the effective methods for treating myopia, reshaping the corneal epithelium to change refractive power. Due to its contact with the ocular surface, long-term wearing could lead to symptoms and signs of dry eye disease(DED) , as well as changes in tear film stability. This prospective study randomly divided 300 children and adolescents with myopia into OK group and spectacles group, with a follow-up of 12 months. At baseline, 1, 3, 6, and 12 months, non-invasive tear breakup time (NIBUT), ocular surface disease index (OSDI) and visual analogue score (VAS) score, tear meniscus height (TMH), conjunctival hyperemia (RS score) and meibomian gland (MG) scores, tear MMP-9 concentration, and point-of-care Lymphotoxin alpha (LTA) test.

Detailed Description
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This study will be conducted in compliance with the tenets of the Declaration of Helsinki and the Institutional Review Board of He Eye Specialist Hospital, Shenyang, China [ethics approval number: 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.

Official Title
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A Single Center,Randomized,Controlled Trial Assessing the Effects of Spectacles or Orthokeratology on Dry Eye Parameters in Children and Adolescents.

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Device: Orthokeratology
* Device: Spectacles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (i)myopia up to -5.5D; and with-the-rule astigmatism of up to 1.5 DC or against-the rule astigmatism of <-0.5DC with keratometry from 40 to 45D ; (ii)participants and guardians agree to be randomly assigned and are willing to cooperate with doctors for follow-up and examination. Exclusion Criteria: (i) existing ocular trauma, infectious diseases, recent surgical history; (ii) keratitis or any ocular inflammation or infection; recently wearing contact lenses; allergy history; (iii) glaucoma, active uveitis or retinal disease; (iv) systemic diseases.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orthokeratology group<br>Participants in OK lenses group will wear OK lenses at least 8 hours per day for 12 months. | Device: Orthokeratology<br>* OK lenses will be used to evaluate the condition that causes dry eye in the treatment of myopia.<br>* Other names: OK lenses;|
| Active Comparator: Spectacles group<br>Participants in spectacles group will wear per day for 12 months. | Device: Spectacles<br>* Spectacles will be used to evaluate the condition that causes dry eye in the treatment of myopia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-invasive tear break-up time | Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded. | Day-0 (baseline), 1-month ,3-month,6-month and 12-month. | 
| OSDI Score | Chinese translated, and validated OSDI (Allergan Inc, Irvine, USA) version will be used to assess and quantify DE symptom. The 12 items of the questionnaire can be tabulated into a score that ranges from 0 (no symptoms) to 100 (severe symptoms) points. | Day-0 (baseline), 1-month ,3-month,6-month and 12-month. | 
| VAS score | VAS is used to evaluate subjective symptoms, such as patient symptoms, emotions, etc. Composed of a 100 mm straight line, the end is defined as the limit of pain to be measured, resulting in a 100 component scale. The patient rated their eye discomfort by marking the continuity from 'no eye discomfort' (score 0) to 'my eye discomfort is as bad as ever' (score 100). | Day-0 (baseline), 1-month ,3-month,6-month and 12-month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear meniscus height (TMH) | Tear meniscus height using the Keratograph 5M (Oculus, Germany) topographer | Day-0 (baseline), 1-month ,3-month,6-month and 12-month. | 
| Conjunctival hyperemia (RS score) | Conjunctival hyperemia (RS score) will be assessed by keratograph image (Oculus, Germany) of 1156*873 pixels, redness score (RS) (accurate to 0.1 U) was displayed on the computer screen that ranged from 0.0 to 4.0. | Day-0 (baseline), 1-month ,3-month,6-month and 12-month. | 
| Meibomian gland score (meiboscore) | Meibomian gland score will be assessed by keratograph image (Oculus, Germany) .The meibomian gland can be scored that ranges from grade 0 (no loss) to grade 3 (more than two third loss). | Day-0 (baseline), 1-month ,3-month,6-month and 12-month. | 
| MMP-9 detection | Inflammation Dry, (Rapid Pathogen Screening Inc., Sarasota, FL, USA) is a patented and proprietary modification of a traditional lateral flow device and uses direct sampling microfiltration technology. | Day-0 (baseline), 1-month ,3-month,6-month and 12-month. | 
| LTA | LTA will be measured using an immunochromatography assay by collecting 1ul tear samples from the lateral canthus using a capillary tear collector. To assess the concentration of LTA in the tear samples, a commercial reagent card (S05B, Seinda Biomedical Corporation, Guangdong, China) based on colloidal gold and immunochromatographic analysis was utilized. | Day-0 (baseline), 1-month ,3-month,6-month and 12-month. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, Orthokeratology, Tear film, Dry eye