Idiopathic Macular HoleTROMACNCT02895594
Outcome of Surgery for Idiopathic Macular Holes
An observational study of Idiopathic Macular Hole, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
Retrospective medical chart review of patients undergoing surgical repair of idiopathic macular hole Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Macular Hole
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to May 2015
- 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: Patients treated by retinal repair surgery for idiopathic macular hole
Who may be able to join
- Patient suffering from primary idiopathic macular hole and treated by retinal repair surgery
Who cannot join
- Presence of other retinal disease
About this study
Retrospective medical chart review of patients undergoing surgical repair of idiopathic macular hole
- Conditions
- Idiopathic Macular Hole
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary closure of macular hole after repair surgery
Measured: within six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJan 2012
- Primary completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Macular HoleStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895594
- Sponsor's protocol ID
- NI_YLR_2015_1
- Acronym
- TROMAC
- Status last verified
- Sep 2016
- First submitted
- 6 Sep 2016
- Last updated
- 12 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Surgery for Idiopathic Macular Holes
- ClinicalTrials.gov ID
- NCT02895594
- Acronym / sponsor ID
- TROMAC / NI_YLR_2015_1
- Conditions
- Idiopathic Macular Hole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Jan 2012
- Primary completion
- May 2015 (actual)
- First posted
- 9 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.
Retrospective medical chart review of patients undergoing surgical repair of idiopathic macular hole
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated by retinal repair surgery for idiopathic macular hole
Key inclusion criteria (1 listed)
- Patient suffering from primary idiopathic macular hole and treated by retinal repair surgery
Key exclusion criteria (1 listed)
- Presence of other retinal disease
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
Primary closure of macular hole after repair surgery
Time frame: within six months after surgery
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 12 Sep 2016.
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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 Idiopathic Macular Hole, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 1 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 12 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?
Primary closure of macular hole after repair surgery (time frame: within six months after surgery). 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 12 Sep 2016.