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

Recruiting

Conditions

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

Observational

Enrollment (Anticipated)

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 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

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
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

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

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)

March 7, 2021

Primary Completion (Anticipated)

March 31, 2022

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 16, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID 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

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.

Clinical Trials on Visual Quality

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe