MyopiaMYOPASNCT02893592
Efficiency, Predictability and Security of the Trans-epithelial Photorefractive Keratectomy
An observational study of Myopia, run by Centre Hospitalier Régional Metz-Thionville.
Trial summary
The photorefractive keratectomy was the first correction mode refractive laser. It's a photo-ablation of a predetermined thickness of anterior corneal stroma. Debridement of epithelium can be done either mechanically (m-PRK) or by laser (trans-PRK). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Mar 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Were included patients with myopia up to -4D (dioptries) and cylinders up to -3D.
Who may be able to join
- patients with stable refractive error (more than 2 years)
- Myopia up to -4.00 diopters and astigmatism up to -3.00 diopters
Who cannot join
- Phototherapeutic keratectomy (PTK)
About this study
Official title: Efficiency, Predictability and Security of the Trans-epithelial Photorefractive Keratectomy (Trans-PRK) for Low and Medium Myopia and Astigmatism: Retrospective Study About 118 Eyes
The photorefractive keratectomy was the first correction mode refractive laser. It's a photo-ablation of a predetermined thickness of anterior corneal stroma. Debridement of epithelium can be done either mechanically (m-PRK) or by laser (trans-PRK). Trans-PRK has a lot of interests: facility and speed of procedure as well as suppression of human variable. Very good results are obtained by m-PRK. The aim of this study is to show equivalence or non inferiority of trans-PRK over conventional m-PRK in terms of safety and refractive efficiency
- Conditions
- Myopia
- Medical subject headings
- Myopia
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
LogMar
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startOct 2015
- Primary completionNov 2015
- Study completionMar 2016
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893592
- Sponsor's protocol ID
- 2015-11Obs-CHRMT
- Acronym
- MYOPAS
- Status last verified
- Aug 2016
- First submitted
- 30 Aug 2016
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency, Predictability and Security of the Trans-epithelial Photorefractive Keratectomy (Trans-PRK) for Low and Medium Myopia and Astigmatism: Retrospective Study About 118 Eyes
- ClinicalTrials.gov ID
- NCT02893592
- Acronym / sponsor ID
- MYOPAS / 2015-11Obs-CHRMT
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 Sep 2016 (estimated)
- 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.
The photorefractive keratectomy was the first correction mode refractive laser. It's a photo-ablation of a predetermined thickness of anterior corneal stroma. Debridement of epithelium can be done either mechanically (m-PRK) or by laser (trans-PRK). Trans-PRK has a lot of interests: facility and speed of procedure as well as suppression of human variable. Very good results are obtained by m-PRK. The aim of this study is to show equivalence or non inferiority of trans-PRK over conventional m-PRK in terms of safety and refractive efficiency
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Were included patients with myopia up to -4D (dioptries) and cylinders up to -3D.
Key inclusion criteria (2 listed)
- patients with stable refractive error (more than 2 years)
- Myopia up to -4.00 diopters and astigmatism up to -3.00 diopters
Key exclusion criteria (1 listed)
- Phototherapeutic keratectomy (PTK)
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
visual acuity
Time frame: Month 2
LogMar
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 15 Sep 2016.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Centre Hospitalier Régional Metz-Thionville.
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 2 inclusion and 1 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 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
visual acuity (time frame: Month 2). 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 15 Sep 2016.