MyopiaNCT05365373
The Effect of Treatment Zone Decentration on Axial Length Elongation After Orthokeratology
An observational study of Myopia and Orthokeratology, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
Orthokeratology lens is an effective method for myopia control. This study analyzed the effects of treatment zone decentration on axial length elongation in adolescents with orthokeratology lens. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Orthokeratology
- How many people
- 251 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
- Healthy volunteers accepted
- 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
- stop wearing for ≥7 days for any reason during the follow-up period
- keratoconjunctival complications, glare, diplopia, or any other symptoms during follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Orthokeratology lens is an effective method for myopia control. This study analyzed the effects of treatment zone decentration on axial length elongation in adolescents with orthokeratology lens.
Read the detailed description
Orthokeratology lens is an effective method for myopia control. This study aimed to investigate the effects of treatment zone decentration on axial length elongation 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, Decentration
- 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 IOL-Master 500, its expressed in mm
Measured: The change of baseline、6 months and 12months
Secondary outcomes (1)
the decentration magnitudes of the treatment zone
The value of decentration magnitudes 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.
- First posted9 May 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.
- 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
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365373
- Sponsor's protocol ID
- 2022005
- Status last verified
- May 2022
- First submitted
- 4 May 2022
- Last updated
- 9 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Treatment Zone Decentration on Axial Length Elongation After Orthokeratology
- ClinicalTrials.gov ID
- NCT05365373
- Acronym / sponsor ID
- 2022005
- Conditions
- Myopia, Orthokeratology
- Keywords
- Myopia, Orthokeratology, Axial length, Decentration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 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
- 9 May 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.
Orthokeratology lens is an effective method for myopia control. This study analyzed the effects of treatment zone decentration on axial length elongation in adolescents with orthokeratology lens.
Detailed description
Orthokeratology lens is an effective method for myopia control. This study aimed to investigate the effects of treatment zone decentration on axial length elongation in adolescents with orthokeratology lens in 1 year. Other factors that may affect axial growth were also analyzed.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- 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
- stop wearing for ≥7 days for any reason during the follow-up period
- keratoconjunctival complications, glare, diplopia, or any other symptoms during 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.
Primary outcome
The change of axial length
Time frame: The change of baseline、6 months and 12months
The axial length was measured by IOL-Master 500, its expressed in mm
1 secondary outcome
the decentration magnitudes of the treatment zone
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 9 May 2022.
- Individual participant dataSharing planned: No
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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 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 9 May 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、6 months and 12months). 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 9 May 2022.