Clinical trial NCT03516357: Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic Children
Official title: Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopia
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 300
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: myopia

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.

Eligibility criteria: 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.

Primary outcomes:
measure: axial length measured by IOL-master
timeFrame: 2 years
Secondary outcomes:
measure: accommodation measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)
timeFrame: 2 years
measure: peripheral refraction measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)
timeFrame: 2 years
measure: IOP measured by Corvis-ST
timeFrame: 2 years
measure: corneal thickness measured by Corvis-ST
timeFrame: 2 years
measure: corneal biomechanical parameters measured by Corvis-ST
timeFrame: 2 years
measure: tear film quality measured by Keratography
timeFrame: 2 years
measure: corneal morphological characteristics measured by Optikon 2000 corneal topographer
timeFrame: 2 years
measure: objective optical quality measured by OQAS visual quality analyzing system
timeFrame: 2 years
measure: corneal and conjunctiva sensitivity measured by Cochet-Bonnet
timeFrame: 2 years
measure: choroidal thickness measured by ocular coherence tomography
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Disease Prevention & Treatment Center
state: Jingan
Study officials:
References: