Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic Children

• Conditions: Myopia

• Registration Number: NCT03516357
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Brief Summary

Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic Children

Detailed Description

1.The primary objective of the current study is to investigate changes in uncorrected visual acuity, diopter, accommodation, peripheral refraction, IOP, tear film quality, corneal thickness, corneal topography, corneal biomechanical parameters, objective optical quality, corneal and conjunctiva sensitivity and choroidal thickness for children with different diopters after wearing orthokeratology lenses; 2. Through measure long-term changes of these parameters, including corneal topography, axial length, peripheral refraction, objective optical quality and choroidal thickness, to explore occurrence and development regularity of myopia.

Study Timeline

• Status Verified: 2017-11
• Study Start: 2018-01-11
• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-23
• Last Update Submitted: 2018-04-23
• Study First Posted: 2018-05-04
• Last Update Posted: 2018-05-04
• Primary Completion: 2022-01-11
• Study Completion: 2022-01-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 1. subjects were 6-16 years of age; 2.had no other ocular diseases aside from refractive error and no keratoconus (confirmed by pre-treatment corneal topography); 3. had an intraocular pressure (IOP) of <21 mmHg; 4. had an with-the- rule astigmatism (axes 180 ± 30) ≤ 1.50 D; 5.had a best corrected visual acuity（BCVA） ≤0.00 log MAR units in both eyes (Snellen equivalent to 20/20);

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Exclusion Criteria

• 1. had binocular vision problems; 2.use medications that might affect refractive development; 3.had history of ortho-k or contact lens wear; 4. Ocular surface diseases and other eye diseases which can cause abnormalities of ocular surface; 5. Patients with histories of ocular injury or surgery; 6. Corneal staining and decentration of lens after wearing Ortho-k.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
axial length measured by IOL-master	2 years	measured by IOL-master

Secondary Outcome Measures

Name	Time	Method
accommodation measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)	2 years	measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)
objective optical quality measured by OQAS visual quality analyzing system	2 years	measured by OQAS visual quality analyzing system
corneal and conjunctiva sensitivity measured by Cochet-Bonnet	2 years	measured by Cochet-Bonnet
corneal biomechanical parameters measured by Corvis-ST	2 years	measured by Corvis-ST
corneal morphological characteristics measured by Optikon 2000 corneal topographer	2 years	measured by Optikon 2000 corneal topographer
IOP measured by Corvis-ST	2 years	measured by Corvis-ST
tear film quality measured by Keratography	2 years	measured by Keratography
peripheral refraction measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)	2 years	measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)
corneal thickness measured by Corvis-ST	2 years	measured by Corvis-ST
choroidal thickness measured by ocular coherence tomography	2 years	measured by ocular coherence tomography

Trial Locations

Locations (1)

Shanghai Eye Disease Prevention & Treatment Center; 🇨🇳 Shanghai, Jingan, China