The Effect of Wearing Orthokeratology on Objective Visual Quality

• Conditions: Visual Quality

• Registration Number: NCT04929119
• Lead Sponsor: XiaoYong Liu

Brief Summary

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)

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 Timeline

• Study Start: 2021-03-07
• Status Verified: 2021-06
• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-16
• Last Update Submitted: 2021-06-16
• Study First Posted: 2021-06-18
• Last Update Posted: 2021-06-18
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

First Affiliated Hospital of Jinan University; 🇨🇳 Guangdong, Guangzhou, China