Effects of Different Designs of Orthokeratology Lens on Myopia Control and Visual Quality

December 30, 2021 updated by: Shuxian zhang, Tianjin Eye Hospital
This study was aimed to evaluate the effects of different Orthokeratology，including the size of central optical zone and the height of peripheral reverse curve, on myopia control and visual quality.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study was aimed to evaluate the effects of different Orthokeratology on myopia control and visual quality. The different optical zone of Orthokeratology lens was divided into 4 groups, ranged from 5.5 mm to 6 mm. And the control group subjects with the single glasses was included. The effectiveness of Orthokeratology was measured by axial length progression. The visual quality of subjects was evaluated by a questionnaire, contrast sensitivity and wavefront aberration.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300020
        • Recruiting
        • Tianjin Eye Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Myopia: between -1.00D and 4.00D in both eyes
  • Astigmatism: <1.5D for with-the-rule astigmatism, <1.00D for the against-the-rule astigmatism
  • Visual acuity: the best corrected vision acuity(BCVA)≥20/20 in both eyes
  • Subjects that volunteer to participate in the clinical trial and sign informed consent

Exclusion Criteria:

  • Contraindications of wearing Ortho-K.
  • Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases.
  • Any type of strabismus or amblyopia
  • Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)
  • Ocular conditions which might affect the refractive error (for example, cataract, ptosis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Single-vision glasses
Subjects wearing single-vision glasses CR-39
EXPERIMENTAL: Orthokeratology lenses group 1
Subjects wearing orthokeratology lenses of 5mm optical zone.
Device: Orthokeratology lens
The intervention was according to the design of different optical zone and peripheral reverse curve
Other Names:
  • Ortho-K
EXPERIMENTAL: Orthokeratology lenses group 2
Subjects wearing orthokeratology lenses of 5.5mm optical zone.
Device: Orthokeratology lens
The intervention was according to the design of different optical zone and peripheral reverse curve
Other Names:
  • Ortho-K
EXPERIMENTAL: Orthokeratology lenses group 3
Subjects wearing orthokeratology lenses of 6mm optical zone.
Device: Orthokeratology lens
The intervention was according to the design of different optical zone and peripheral reverse curve
Other Names:
  • Ortho-K
EXPERIMENTAL: Orthokeratology lenses group 4
Subjects wearing orthokeratology lenses of 6mm optical zone and the increased height of peripheral reverse curve.
Device: Orthokeratology lens
The intervention was according to the design of different optical zone and peripheral reverse curve
Other Names:
  • Ortho-K

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in axial length in 2 years
Time Frame: Every 6 months for a period 2 years
The axial length was measured by AL-scan
Every 6 months for a period 2 years
Changes in Cycloplegic subjective refraction in 2 years
Time Frame: Every 6 months for a period 2 years
The cycloplegic subjective refraction was evaluated by optometrist
Every 6 months for a period 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in visual questionnaire as compared to baseline（Postoperative 6 months, 12 months, 18 months and 24 months）
Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
The symptoms score measured by a visual questionnaire, each symptom was evaluated on a scale of 0 to 10.
baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in High-order aberrations (HOAs) in microns as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months)
Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Ocular aberration measured by Zeiss i. Profiler Plus aberrometer
baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in contrast sensitivity as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）
Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Contrast sensitivity measured by Stereo optical 6500
baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in choroidal thickness captured by Optical Coherent Tomographer (OCT) as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）
Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
choroidal thickness captured by Optical Coherent Tomographer (OCT) and measured using a customized software
baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in Corneal epithelial thickness captured by Optical Coherent Tomographer (OCT) as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）
Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Corneal epithelial thickness captured by Optical Coherent Tomographer (OCT) customized software
baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in corneal biomechanics parameters (SSI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Corneal response parameters(SSI) was evaluated by Corvis ST.
baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in peripheral refraction as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
Peripheral refraction measured by multispectral refraction topography
baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in corneal surface regularity index (SRI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
The corneal surface regularity index (SRI) was measured by Corneal Topography.
baseline, postoperative 6 months, 12 months, 18 months and 24 months
Change in corneal surface asymmetry index (SAI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
Time Frame: baseline, postoperative 6 months, 12 months, 18 months and 24 months
The corneal surface asymmetry index (SAI) was measured by Corneal Topography.
baseline, postoperative 6 months, 12 months, 18 months and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 10, 2021

Primary Completion (ANTICIPATED)

December 31, 2025

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

December 30, 2021

First Posted (ACTUAL)

January 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2022

Last Update Submitted That Met QC Criteria

December 30, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TianjinEH-Orthokeratology lens

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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