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Visual QualityNCT04929119

The Effect of Wearing Orthokeratology on Objective Visual Quality

An observational study of Visual Quality, run by XiaoYong Liu at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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) … Read more about this study

Who is it for?
Ages 8 to 25 years
Conditions the study is for
Visual Quality
How many people
30 participants
Where
1 siteChina
Study dates
7 Mar 2021to 31 Mar 2022
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

xiaoyong Liu contact

86-13760638809

jndxlxy@163.com

China1 site, 1 recruiting

  • First Affiliated Hospital of Jinan University

    Guangdong, Guangzhou, 510632

    Xiaoyong Liu, 86-13760638809, jndxlxy@163.com

    Recruiting

Other trials in China

About this study

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)

Read the 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)

Conditions
Visual Quality
Keywords
Objective visual quality, Orthokeratology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04929119
Study groupRoleWhat they receive
Before wearing the OrthokeratologyOPD-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 weekOPD-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 monthOPD-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 monthsOPD-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 monthsOPD-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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 4 mm high-order strehl ratio

    Objective visual quality 1

    Measured: 6 months

  2. 4 mm high-order corneal aberrations (Hoa) in Microns

    Objective visual quality 2

    Measured: 6 months

  3. Spherical Aberrations (SA) in Microns

    Objective visual quality 3

    Measured: 6 months

  4. Coma Aberrations (COMA) in Microns

    Objective visual quality 4

    Measured: 6 months

  5. Trefoil Aberrations in Microns

    Objective visual quality 5

    Measured: 6 months

  6. corneal aspheric index(Q)

    Objective visual quality 6

    Measured: 6 months

  7. corneal aspheric index(e)

    Objective visual quality 7

    Measured: 6 months

  8. corneal surface regularity index (SRI)

    Objective visual quality 8

    Measured: 6 months

  9. corneal surface asymmetry index (Sai)

    Objective visual quality 9

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2021
  2. Study start7 Mar 2021
  3. Primary completion31 Mar 2022 (estimated)
  4. Study completion31 Mar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
30 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04929119
Sponsor's protocol ID
2021jnU
Status last verified
Jun 2021
First submitted
14 Jun 2021
Last updated
18 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 26875007

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

    PubMed 16637967

  • 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.

    PubMed 20506992

  • 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.

    PubMed 31179186

  • 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.

    PubMed 24681612

  • 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.

    PubMed 38968599

Questions about this trial

What is this clinical trial studying?

An observational study of Visual Quality, run by XiaoYong Liu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact xiaoyong Liu (86-13760638809, jndxlxy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

4 mm high-order strehl ratio (time frame: 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04929119, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.

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