Clinical trial NCT04929119: The Effect of Wearing Orthokeratology on Objective Visual Quality
Official title: The Effect of Wearing Orthokeratology on Objective Visual Quality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Visual Quality
Keywords: Objective visual quality
Orthokeratology
Lead sponsor: First Affiliated Hospital of Jinan University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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)

Eligibility criteria: 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.

Primary outcomes:
measure: 4 mm high-order strehl ratio
timeFrame: 6 months
measure: 4 mm high-order corneal aberrations (Hoa) in Microns
timeFrame: 6 months
measure: Spherical Aberrations (SA) in Microns
timeFrame: 6 months
measure: Coma Aberrations (COMA) in Microns
timeFrame: 6 months
measure: Trefoil Aberrations in Microns
timeFrame: 6 months
measure: corneal aspheric index(Q)
timeFrame: 6 months
measure: corneal aspheric index(e)
timeFrame: 6 months
measure: corneal surface regularity index (SRI)
timeFrame: 6 months
measure: corneal surface asymmetry index (Sai)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangdong
country: China
facility: First Affiliated Hospital of Jinan University
state: Guangzhou
Study officials:
References:
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citation: Lian Y, Shen M, Huang S, Yuan Y, Wang Y, Zhu D, Jiang J, Mao X, Wang J, Lu F. Corneal reshaping and wavefront aberrations during overnight orthokeratology. Eye Contact Lens. 2014 May;40(3):161-8. doi: 10.1097/ICL.0000000000000031.