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

Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic

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

Study Overview

• Status: Unknown
• Conditions: Myopia

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Jingan
    • Shanghai, Jingan, China, 380 Kangding Road
      • Recruiting
      • Shanghai Eye Disease Prevention & Treatment Center
      • Contact: Zhu Mengjun, MD; Phone Number: 86-21-62565920
      • Principal Investigator: Zhu Mengjun, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

myopia

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
low myopia; -3.00D < spherical equivalent refractive error < -0.50D
moderate myopia; -6.00D < spherical equivalent refractive error ≤ -3.0D
high myopia; spherical equivalent refractive error ≤ -6.0D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
axial length measured by IOL-master	measured by IOL-master	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
IOP measured by Corvis-ST	measured by Corvis-ST	2 years
corneal thickness measured by Corvis-ST	measured by Corvis-ST	2 years
corneal biomechanical parameters measured by Corvis-ST	measured by Corvis-ST	2 years
tear film quality measured by Keratography	measured by Keratography	2 years
corneal morphological characteristics measured by Optikon 2000 corneal topographer	measured by Optikon 2000 corneal topographer	2 years
objective optical quality measured by OQAS visual quality analyzing system	measured by OQAS visual quality analyzing system	2 years
corneal and conjunctiva sensitivity measured by Cochet-Bonnet	measured by Cochet-Bonnet	2 years
choroidal thickness measured by ocular coherence tomography	measured by ocular coherence tomography	2 years

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2018
• Primary Completion (Anticipated): January 11, 2022
• Study Completion (Anticipated): January 11, 2022

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): May 4, 2018

Study Record Updates

• Last Update Posted (Actual): May 4, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: YFZX2017002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No