The Effect of Wearing Orthokeratology on Objective Visual Quality

NCT ID: NCT04929119

Last Updated: 2021-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-07

Study Completion Date

2022-03-31

Brief Summary

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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

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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)

Conditions

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Visual Quality

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

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)

No interventions assigned to this group

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)

No interventions assigned to this group

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)

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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XiaoYong Liu

OTHER

Sponsor Role lead

Responsible Party

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XiaoYong Liu

Deputy chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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First Affiliated Hospital of Jinan University

Guangdong, Guangzhou, China

Site Status RECRUITING

Countries

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China

Central Contacts

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xiaoyong Liu

Role: CONTACT

86-13760638809

Facility Contacts

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Xiaoyong Liu

Role: primary

86-13760638809

References

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Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.

Reference Type BACKGROUND
PMID: 26875007 (View on PubMed)

Swarbrick HA. Orthokeratology review and update. Clin Exp Optom. 2006 May;89(3):124-43. doi: 10.1111/j.1444-0938.2006.00044.x.

Reference Type BACKGROUND
PMID: 16637967 (View on PubMed)

Goldstone RN, Yildiz EH, Fan VC, Asbell PA. Changes in higher order wavefront aberrations after contact lens corneal refractive therapy and LASIK surgery. J Refract Surg. 2010 May;26(5):348-55. doi: 10.3928/1081597X-20100218-03. Epub 2010 May 19.

Reference Type BACKGROUND
PMID: 20506992 (View on PubMed)

Yin Y, Zhao Y, Wu X, Jiang M, Xia X, Chen Y, Song W, Hu S, Zhou X, Young K, Wen D. One-year effect of wearing orthokeratology lenses on the visual quality of juvenile myopia: a retrospective study. PeerJ. 2019 May 30;7:e6998. doi: 10.7717/peerj.6998. eCollection 2019.

Reference Type BACKGROUND
PMID: 31179186 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24681612 (View on PubMed)

Cheng Z, Meng J, Ye L, Wang X, Gong Y, Liu X. Changes in the Objective Vision Quality of Adolescents in a Mesopic Visual Environment After Wearing Orthokeratology Lenses: A Prospective Study. Eye Contact Lens. 2024 Sep 1;50(9):384-394. doi: 10.1097/ICL.0000000000001111. Epub 2024 Jul 3.

Reference Type DERIVED
PMID: 38968599 (View on PubMed)

Other Identifiers

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2021jnU

Identifier Type: -

Identifier Source: org_study_id

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