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

NCT ID: NCT03516357

Last Updated: 2018-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-11
• Study Completion Date: 2022-01-11

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.

Conditions

Myopia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

low myopia

-3.00D \< spherical equivalent refractive error \< -0.50D

No interventions assigned to this group

moderate myopia

-6.00D \< spherical equivalent refractive error ≤ -3.0D

No interventions assigned to this group

high myopia

spherical equivalent refractive error ≤ -6.0D

No interventions assigned to this group

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Jingan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhu Mengjun, MD

Role: CONTACT

morning5012@163.com

86-21-62565920

Facility Contacts

Zhu Mengjun, MD

Role: primary

86-21-62565920

Other Identifiers

YFZX2017002

Identifier Type: -

Identifier Source: org_study_id