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

Myopia Clinical Trial

Official title:

Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03516357
• Other study ID #: YFZX2017002
• Status: Recruiting
• Start date: January 11, 2018
• Est. completion date: January 11, 2022

Study information

• Verified date: November 2017
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: Zhu Mengjun, MD
• Phone: 86-21-62565920
• Email: morning5012[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 11, 2022
• Est. primary completion date: January 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Locations

Country	Name	City	State
China	Shanghai Eye Disease Prevention & Treatment Center	Shanghai	Jingan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	axial length measured by IOL-master	measured by IOL-master	2 years
Secondary	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)	2 years
Secondary	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)	2 years
Secondary	IOP measured by Corvis-ST	measured by Corvis-ST	2 years
Secondary	corneal thickness measured by Corvis-ST	measured by Corvis-ST	2 years
Secondary	corneal biomechanical parameters measured by Corvis-ST	measured by Corvis-ST	2 years
Secondary	tear film quality measured by Keratography	measured by Keratography	2 years
Secondary	corneal morphological characteristics measured by Optikon 2000 corneal topographer	measured by Optikon 2000 corneal topographer	2 years
Secondary	objective optical quality measured by OQAS visual quality analyzing system	measured by OQAS visual quality analyzing system	2 years
Secondary	corneal and conjunctiva sensitivity measured by Cochet—Bonnet	measured by Cochet—Bonnet	2 years
Secondary	choroidal thickness measured by ocular coherence tomography	measured by ocular coherence tomography	2 years