The Effect of Wearing Orthokeratology on Objective Visual Quality

June 16, 2021 updated by: XiaoYong Liu
The visual quality indexes of these patients before and after Orthokeratology treatment were compared: 4 mm higher strehl ratio (SR) , 4 mm higher order corneal aberrations (Hoa ) , Spherical Aberrations (SA) , Comas, Trefoil Aberrations (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)

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.

Detailed Description

USING OPD-SCAN III instrument method: Drag The joystick to focus on the screen prompt, and the device automatically starts to measure the aberration when the yellow focus is shown; Simk will change from black to rose red when the aberration is measured to start measuring the corneal topography, prompting the patient to blink the tear film evenly and press the button on the joystick when the focus is completed.The following data were obtained and analyzed: 4 mm high order STREHL rate (SR) , 4 mm high order corneal aberration (Hoa ) , Spherical Aberration (SA) , Coma Aberration (Coma) , Trefoil Aberration (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)

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.
Observational

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.
30

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
    • Guangzhou
      • Guangdong, Guangzhou, China, 510632
        • Recruiting
        • First Affiliated Hospital of Jinan University
        • 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 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Before wearing the Orthokeratology:30cases;Wear Orthokeratology for a week:30cases;Wear Orthokeratology for a month:30cases;Wear Orthokeratology for three months:30cases;Wear Orthokeratology for six months:30cases

Description

Inclusion Criteria:

  • The subject understands the purpose of this clinical trial and is willing, able and committed to return to the center for all clinical trial visits and to complete all research related procedures

Exclusion Criteria:

  • 1. Associated with corneal abnormalities, such as active Keratitis (corneal infection) , corneal dystrophy, Keratoconus, corneal Leukoplakia, corneal hypoesthesia, or previous corneal surgery, or a history of corneal trauma;
  • 2, there are other eye diseases, such as Dacryocystitis, dry eye disease, conjunctivitis, blepharitis, Uveitis, and other inflammation, Glaucoma, cataracts, fundus disease, eye tumors, ocular trauma, squint patients;
  • 3. A history of allergy to contact lens or contact Lens Solution.
  • 4. Test results indicate that subjects with contraindications or unsuitable for wearing Orthokeratology.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Before wearing the Orthokeratology
OPD-Scan was performed and the following data were recorded: 4 mm high order strehl ratio (SR) , 4 mm high order corneal aberrations (Hoa ) , Spherical Aberrations (SA) , Coma Aberrations (Coma) , Trefoil Aberrations (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)
Wear Orthokeratology for a week
OPD-Scan was performed and the following data were recorded: 4 mm high order strehl ratio (SR) , 4 mm high order corneal aberrations (Hoa ) , Spherical Aberrations (SA) , Coma Aberrations (Coma) , Trefoil Aberrations (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)
Wear Orthokeratology for a month
OPD-Scan was performed and the following data were recorded: 4 mm high order strehl ratio (SR) , 4 mm high order corneal aberrations (Hoa ) , Spherical Aberrations (SA) , Coma Aberrations (Coma) , Trefoil Aberrations (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)
Wear Orthokeratology for three months
OPD-Scan was performed and the following data were recorded: 4 mm high order strehl ratio (SR) , 4 mm high order corneal aberrations (Hoa ) , Spherical Aberrations (SA) , Coma Aberrations (Coma) , Trefoil Aberrations (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)
Wear Orthokeratology for six months
OPD-Scan was performed and the following data were recorded: 4 mm high order strehl ratio (SR) , 4 mm high order corneal aberrations (Hoa ) , Spherical Aberrations (SA) , Coma Aberrations (Coma) , Trefoil Aberrations (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)

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
4 mm high-order strehl ratio
Time Frame: 6 months
Objective visual quality 1
6 months
4 mm high-order corneal aberrations (Hoa) in Microns
Time Frame: 6 months
Objective visual quality 2
6 months
Spherical Aberrations (SA) in Microns
Time Frame: 6 months
Objective visual quality 3
6 months
Coma Aberrations (COMA) in Microns
Time Frame: 6 months
Objective visual quality 4
6 months
Trefoil Aberrations in Microns
Time Frame: 6 months
Objective visual quality 5
6 months
corneal aspheric index(Q)
Time Frame: 6 months
Objective visual quality 6
6 months
corneal aspheric index(e)
Time Frame: 6 months
Objective visual quality 7
6 months
corneal surface regularity index (SRI)
Time Frame: 6 months
Objective visual quality 8
6 months
corneal surface asymmetry index (Sai)
Time Frame: 6 months
Objective visual quality 9
6 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.
XiaoYong Liu

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.
March 7, 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.
March 31, 2022

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.
March 31, 2022

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).
June 14, 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.
June 16, 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.
June 18, 2021

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.
June 18, 2021

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.
June 16, 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.
June 1, 2021

More Information

Terms related to this study

Keywords

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.
  • 2021jnU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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