NCT04929119

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

1.1 years

First QC Date

June 14, 2021

Last Update Submit

June 16, 2021

Conditions

Visual Quality

Keywords

Objective visual qualityOrthokeratology

Outcome Measures

Primary Outcomes (9)

  • 4 mm high-order strehl ratio

    Objective visual quality 1

    6 months

  • 4 mm high-order corneal aberrations (Hoa) in Microns

    Objective visual quality 2

    6 months

  • Spherical Aberrations (SA) in Microns

    Objective visual quality 3

    6 months

  • Coma Aberrations (COMA) in Microns

    Objective visual quality 4

    6 months

  • Trefoil Aberrations in Microns

    Objective visual quality 5

    6 months

  • corneal aspheric index(Q)

    Objective visual quality 6

    6 months

  • corneal aspheric index(e)

    Objective visual quality 7

    6 months

  • corneal surface regularity index (SRI)

    Objective visual quality 8

    6 months

  • corneal surface asymmetry index (Sai)

    Objective visual quality 9

    6 months

Study Arms (5)

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)

Eligibility Criteria

Age8 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • \. 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;
  • , 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;
  • \. A history of allergy to contact lens or contact Lens Solution.
  • \. Test results indicate that subjects with contraindications or unsuitable for wearing Orthokeratology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Jinan University

Guangdong, Guangzhou, 510632, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 26875007BACKGROUND

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

    PMID: 16637967BACKGROUND

  • 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.

    PMID: 20506992BACKGROUND

  • 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.

    PMID: 31179186BACKGROUND

  • 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.

    PMID: 24681612BACKGROUND

  • 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.

    PMID: 38968599DERIVED

Central Study Contacts

xiaoyong Liu

CONTACT

86-13760638809jndxlxy@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy chief physician

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 18, 2021

Study Start

March 7, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

CN(1)