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

Shanghai Eye Disease Prevention and Treatment Center300 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Myopia

Eligibility

Sex: ALLMin age: 8 YearsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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); 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.

Locations (1)

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Jingan, China

RECRUITING

Outcomes

Primary Outcomes

axial length measured by IOL-master

measured by IOL-master

Time frame: 2 years

Secondary Outcomes

accommodation measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)

measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)

Time frame: 2 years

peripheral refraction measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)

measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)

Time frame: 2 years

IOP measured by Corvis-ST

measured by Corvis-ST

Time frame: 2 years

corneal thickness measured by Corvis-ST

measured by Corvis-ST

Time frame: 2 years

corneal biomechanical parameters measured by Corvis-ST

measured by Corvis-ST

Time frame: 2 years

tear film quality measured by Keratography

measured by Keratography

Time frame: 2 years

corneal morphological characteristics measured by Optikon 2000 corneal topographer

measured by Optikon 2000 corneal topographer

Time frame: 2 years

objective optical quality measured by OQAS visual quality analyzing system

Central Contacts

Zhu Mengjun, MD

CONTACT

86-21-62565920 morning5012@163.com

Data from ClinicalTrials.gov

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