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

Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03516357
Enrollment
300
Registered
2018-05-04
Start date
2018-01-11
Completion date
2022-01-11
Last updated
2018-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

None listed

Sponsors

Shanghai Eye Disease Prevention and Treatment Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 15 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
axial length measured by IOL-master2 yearsmeasured by IOL-master

Secondary

MeasureTime frameDescription
corneal thickness measured by Corvis-ST2 yearsmeasured by Corvis-ST
corneal biomechanical parameters measured by Corvis-ST2 yearsmeasured by Corvis-ST
tear film quality measured by Keratography2 yearsmeasured by Keratography
accommodation measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)2 yearsmeasured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)
IOP measured by Corvis-ST2 yearsmeasured by Corvis-ST
corneal morphological characteristics measured by Optikon 2000 corneal topographer2 yearsmeasured by Optikon 2000 corneal topographer
objective optical quality measured by OQAS visual quality analyzing system2 yearsmeasured by OQAS visual quality analyzing system
corneal and conjunctiva sensitivity measured by Cochet-Bonnet2 yearsmeasured by Cochet-Bonnet
choroidal thickness measured by ocular coherence tomography2 yearsmeasured by ocular coherence tomography
peripheral refraction measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)2 yearsmeasured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)

Countries

China

Contacts

Primary ContactZhu Mengjun, MD
morning5012@163.com86-21-62565920

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026