Myopia ProgressionNCT05700240
Effect of Orthokeratology on Myopia Progression in French Children
An observational study of Myopia Progression, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
To evaluate and to compare the effect of orthokeratology (OK) on axial elongation in French myopic children. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia Progression
- What is being tested?
- orthokeratology and single-vision spectacle correction
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2019to 24 Dec 2020
- 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 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 64 consecutive myopic children who underwent OK treatment or single-vision spectacle correction at a private ophthalmology clinic in Nancy from November 2019 to December 2020
Who may be able to join
- 7 to 17 years old
- Myopia between 0,50 D and 7.00 D
- Astigmatism ≤ 4.00 D with-the-rule 180+-20
- Anisometropia ≤ 1.50 D
- Myopia evolution ≥ 0.25 D over 6 months
- Best-corrected visual acuity (BCVA) ≥ 20/20 (Snellen equivalent)
- Follow-up period > 6 months
Who cannot join
- Prior history of any other myopia control treatment (except for single vision distance spectacles)
- Contraindication for contact lens wear or orthokeratology
- Preexisting ocular (amblyopia, strabismus, ocular inflammation, trauma, or surgery) or systemic disease
- Poor compliance to lens wear, examination or follow-up
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate and to compare the effect of orthokeratology (OK) on axial elongation in French myopic children.
- Conditions
- Myopia Progression
- Being tested
- orthokeratology, single-vision spectacle correction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthokeratologyDevice
rigid contact lenses
single-vision spectacle correctionDevice
simple wear of spectacle
| Study group | Role | What they receive |
|---|---|---|
| Orthokeratology treatment | Not described Receives: Device: orthokeratology | |
| single-vision spectacle correction | Not described Receives: Device: single-vision spectacle correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in axial length at one year
Measured: one year
Secondary outcomes (2)
changes in refractive error
Measured: one year
changes in choroidal thickness
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start2 Nov 2019
- Primary completion29 Jun 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia ProgressionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professeur Jean-Baptiste CONART, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700240
- Sponsor's protocol ID
- 2022PI090
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Orthokeratology on Myopia Progression in French Children
- ClinicalTrials.gov ID
- NCT05700240
- Acronym / sponsor ID
- 2022PI090
- Conditions
- Myopia Progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 2 Nov 2019 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 26 Jan 2023 (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.
To evaluate and to compare the effect of orthokeratology (OK) on axial elongation in French myopic children.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthokeratology treatment | – | Device: orthokeratology |
| single-vision spectacle correction | – | Device: single-vision spectacle correction |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 64 consecutive myopic children who underwent OK treatment or single-vision spectacle correction at a private ophthalmology clinic in Nancy from November 2019 to December 2020
Key inclusion criteria (7 listed)
- 7 to 17 years old
- Myopia between 0,50 D and 7.00 D
- Astigmatism ≤ 4.00 D with-the-rule 180+-20
- Anisometropia ≤ 1.50 D
- Myopia evolution ≥ 0.25 D over 6 months
Key exclusion criteria (4 listed)
- Prior history of any other myopia control treatment (except for single vision distance spectacles)
- Contraindication for contact lens wear or orthokeratology
- Preexisting ocular (amblyopia, strabismus, ocular inflammation, trauma, or surgery) or systemic disease
- Poor compliance to lens wear, examination or follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orthokeratologyrigid contact lenses | Device | Orthokeratology treatment |
| single-vision spectacle correctionsimple wear of spectacle | Device | single-vision spectacle correction |
Primary outcome
Changes in axial length at one year
Time frame: one year
2 secondary outcomes
changes in refractive error
Time frame: one year
changes in choroidal thickness
Time frame: one 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 26 Jan 2023.
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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 Progression, run by Central Hospital, Nancy, France at 1 site in France.
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 7 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: finished, as of the sponsor's last update on 26 Jan 2023. 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 France. 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?
Changes in axial length at one year (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2023.