Myopic Traction MaculopathyNCT04278079
Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy
A study testing Pars Plana Vitrectomy with Internal Limiting Membrane peel in people with Myopic Traction Maculopathy and Pars Plana Vitrectomy, run by Tanta University.
Trial summary
Investigate the effectiveness and safety of pars plans vitrectomy, with internal limiting membrane peeling for cases of myopic traction maculopathy Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Myopic Traction Maculopathy, Pars Plana Vitrectomy, Internal Limiting Membrane Peeling
- What is being tested?
- Pars Plana Vitrectomy with Internal Limiting Membrane peel
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Feb 2020
- Phase
- Interventional
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Highly myopic patients, having a refractive errors (spherical equivalent) of more than - 8 Diopter, or an axial length more than 26.5 mm.
- Best Corrected Visual Acuity less than 0.1
- Spectral Domain Optical Coherence Tomography showed; staphylomatous changes, with either: Macular retinoschisis, foveal retinal detachment, full thickness macular hole (with or without macualr hole retinal detachment), or lamellar macular hole, with epiretinal membrane
- At least 6 months follow-up
Who cannot join
- Eyes with diffuse chorioretinal macular atrophy
- Concomitant presence of a choroidal neovascular membrane
- Young patients less than 21 years old.
- History of trauma
- Dense media opacity (corneal/ lenticular)
About this study
Official title: Evaluation of Pars Plana Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy
Investigate the effectiveness and safety of pars plans vitrectomy, with internal limiting membrane peeling for cases of myopic traction maculopathy
Read the detailed description
Performing pars plana vitrectomy for highly myopic patients with decreased visual acuity is the standard of care for patients with myopic traction. A variety of findings are seen by Optical Coherence Tomography. Epiretinal membranes, retinoschisis, lamellar macular holes, and full thickness macular holes are seen. Undergoing vitrectomy, with or without tamponade, in our center, is retrospectively evaluated. Visual acuity change, as well as improvement of the retinal structure by OCT will be examined.
- Being tested
- Pars Plana Vitrectomy with Internal Limiting Membrane peel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars Plana Vitrectomy with Internal Limiting Membrane peelProcedure or surgery
Pars plana vitrectomy with staining and peeling of internal limiting membrane
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of best corrected visual acuity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study startJan 2015
- Primary completionDec 2019
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopic Traction MaculopathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharif Yousef El Emam, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278079
- Sponsor's protocol ID
- TUORU001
- Status last verified
- Feb 2020
- First submitted
- 12 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- 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 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pars Plana Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy
- ClinicalTrials.gov ID
- NCT04278079
- Acronym / sponsor ID
- TUORU001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 20 Feb 2020 (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.
Investigate the effectiveness and safety of pars plans vitrectomy, with internal limiting membrane peeling for cases of myopic traction maculopathy
Detailed description
Performing pars plana vitrectomy for highly myopic patients with decreased visual acuity is the standard of care for patients with myopic traction. A variety of findings are seen by Optical Coherence Tomography. Epiretinal membranes, retinoschisis, lamellar macular holes, and full thickness macular holes are seen. Undergoing vitrectomy, with or without tamponade, in our center, is retrospectively evaluated. Visual acuity change, as well as improvement of the retinal structure by OCT will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Highly myopic patients, having a refractive errors (spherical equivalent) of more than - 8 Diopter, or an axial length more than 26.5 mm.
- Best Corrected Visual Acuity less than 0.1
- Spectral Domain Optical Coherence Tomography showed; staphylomatous changes, with either: Macular retinoschisis, foveal retinal detachment, full thickness macular hole (with or without macualr hole retinal detachment), or lamellar macular hole, with epiretinal membrane
- At least 6 months follow-up
Key exclusion criteria (5 listed)
- Eyes with diffuse chorioretinal macular atrophy
- Concomitant presence of a choroidal neovascular membrane
- Young patients less than 21 years old.
- History of trauma
- Dense media opacity (corneal/ lenticular)
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 |
|---|---|---|
| Pars Plana Vitrectomy with Internal Limiting Membrane peelPars plana vitrectomy with staining and peeling of internal limiting membrane | Procedure or surgery | – |
Primary outcome
Improvement of best corrected visual acuity
Time frame: 6 months
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 20 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Myopic Traction Maculopathy
Recruiting
Predictors of Vitrectomy Outcomes in Myopic Foveoschisis
Myopic Traction Maculopathy
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?
A study testing Pars Plana Vitrectomy with Internal Limiting Membrane peel in people with Myopic Traction Maculopathy and Pars Plana Vitrectomy, run by Tanta University.
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 4 inclusion and 5 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 20 Feb 2020. 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?
Improvement of best corrected visual acuity (time frame: 6 months). 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 20 Feb 2020.