MyopiaNCT05348369

The Relationship of Relative Corneal Refractive Power Shift and Axial Length in Adolescents With Orthokeratology Lens

An observational study of Myopia and Orthokeratology, run by Tianjin Eye Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Orthokeratology lens is an effective method for myopia control. This study analyzed the relationship between the relative corneal refractive power shift and change of axial length in adolescents with orthokeratology lens. Read more about this study

Who is it for?: Ages 8 to 15 years
Conditions the study is for: Myopia, Orthokeratology
How many people: 364 participants
Where: 1 siteChina
Study dates: 1 Jan 2018to 31 Dec 2019
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 15 years
All sexes
Child

Study population: Myopia children with orthokeratology lens and complete follow-up.

Who may be able to join

age from 8 to 15years
spherical equivalent(SE) was range from -1.00D to -5.00D
conform to the standard of wearing orthokeratology lens

Who cannot join

ocular diseases and systemic diseases
visual acuity was less than 20/20
unable to follow visitors on time

Trial locations and contacts

1 site in 1 country.

China1 site

Tianjin Eye Hospital
Tianjin, Tianjin Municipality

Other trials in China

About this study

Read the detailed description

Orthokeratology lens is an effective method for myopia control. This study aimed to investigate the relationship between the relative corneal refractive power shift and changes of axial length in adolescents with orthokeratology lens in 1 year. Other factors that may affect axial growth were also analyzed.

Conditions: Myopia, Orthokeratology
Keywords: Myopia, Orthokeratology, Axial length
Medical subject headings: Myopia

What is being measured

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

The change of axial length
The axial length was measured by AL-scan, its expressed in mm
Measured: The change of baseline and 1years

Secondary outcomes (1)

Relative corneal refractive power shift(RCRPS)
The value of RCRPS was obtained and calculated from a corneal topography
Measured: up to 1 year

Timeline

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

1 Jan 201831 Dec 2019

First posted27 Apr 2022
Study start1 Jan 2018
Primary completion31 Dec 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for MyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Other
Time perspective: Retrospective
Enrolment: 364 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05348369
Sponsor's protocol ID: 2022020
Status last verified: Apr 2022
First submitted: 20 Apr 2022
Last updated: 27 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Vincent SJ, Cho P, Chan KY, Fadel D, Ghorbani-Mojarrad N, Gonzalez-Meijome JM, Johnson L, Kang P, Michaud L, Simard P, Jones L. CLEAR - Orthokeratology. Cont Lens Anterior Eye. 2021 Apr;44(2):240-269. doi: 10.1016/j.clae.2021.02.003. Epub 2021 Mar 25.
PubMed 33775379
Guo B, Cheung SW, Kojima R, Cho P. One-year results of the Variation of Orthokeratology Lens Treatment Zone (VOLTZ) Study: a prospective randomised clinical trial. Ophthalmic Physiol Opt. 2021 Jul;41(4):702-714. doi: 10.1111/opo.12834. Epub 2021 May 15.
PubMed 33991112

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Relationship of Relative Corneal Refractive Power Shift and Axial Length in Adolescents With Orthokeratology Lens
ClinicalTrials.gov ID: NCT05348369
Acronym / sponsor ID: 2022020
Conditions: Myopia, Orthokeratology
Keywords: Myopia, Orthokeratology, Axial length
Study type: Observational
Recruitment status: Completed
Enrolment: 364 participants (actual)
Lead sponsor: Tianjin Eye HospitalUniversity, hospital or other
Study start: 1 Jan 2018 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 27 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Retrospective

Who may qualify

Ages: 8 to 15 years
Sex: All
Age groups: Child
Study population: Myopia children with orthokeratology lens and complete follow-up.

Key inclusion criteria (3 listed)

age from 8 to 15years
spherical equivalent(SE) was range from -1.00D to -5.00D
conform to the standard of wearing orthokeratology lens

Key exclusion criteria (3 listed)

ocular diseases and systemic diseases
visual acuity was less than 20/20
unable to follow visitors on time

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

The change of axial length
Time frame: The change of baseline and 1years
The axial length was measured by AL-scan, its expressed in mm

1 secondary outcome

Relative corneal refractive power shift(RCRPS)
Time frame: up to 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
Background: PubMed 33775379Vincent SJ, Cho P, Chan KY, Fadel D, Ghorbani-Mojarrad N, Gonzalez-Meijome JM, Johnson L, Kang P, Michaud L, Simard P, Jones L. CLEAR - Orthokeratology. Cont Lens Anterior Eye. 2021 Apr;44(2):240-269. doi: 10.1016/j.clae.2021.02.003. Epub 2021 Mar 25.
Background: PubMed 33991112Guo B, Cheung SW, Kojima R, Cho P. One-year results of the Variation of Orthokeratology Lens Treatment Zone (VOLTZ) Study: a prospective randomised clinical trial. Ophthalmic Physiol Opt. 2021 Jul;41(4):702-714. doi: 10.1111/opo.12834. Epub 2021 May 15.
Individual participant dataSharing planned: No

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Myopia and Orthokeratology, run by Tianjin Eye Hospital 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 27 Apr 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of axial length (time frame: The change of baseline and 1years). 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 NCT05348369, which also lists 2 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 27 Apr 2022.