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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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