Idiopathic Macular HoleNCT00941291
Outcome of Idiopathic Macular Hole
An observational study of Idiopathic Macular Hole, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The purpose of this study is to evaluate the role of cataract surgery and cystoid macular edema (CME) on reopening of idiopathic macular holes (IMH). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Idiopathic Macular Hole
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2002to Jan 2005
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One hundred and thirty patients (135 eyes) with stage 2, 3, or 4 IMH were included after successful IMH repair
Who may be able to join
- Patients with with stage 2, 3, or 4 Idiopathic Macular Hole after successful Idiopathic Macular Hole repair
Who cannot join
- All patients without stage 2, 3, or 4 Idiopathic Macular Hole repair
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Outcome of Idiopathic Macular Hole Surgery
The purpose of this study is to evaluate the role of cataract surgery and cystoid macular edema (CME) on reopening of idiopathic macular holes (IMH).
- Conditions
- Idiopathic Macular Hole
- Keywords
- idiopathic macular hole, cataract, edema, Reopening
- Medical subject headings
- Cataract, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| vitrectomy in pseudophakic eyes | Not described | |
| vitrectomy and cataract:combined procedure | Not described | |
| vitrectomy followed by cataract extraction | Not described | |
| vitrectomy on phakic eyes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term outcome of idiopathic macular hole surgery
Measured: 37 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startJan 2002
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Macular HoleStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Investigators
- Catherine Creuzot-Gracher, MD, PhD, Principal investigator, Ophthalmology unit CHU Dijon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941291
- Sponsor's protocol ID
- Macular hole 1
- Status last verified
- Jul 2009
- First submitted
- 30 Mar 2009
- Last updated
- 17 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Passemard M, Yakoubi Y, Muselier A, Hubert I, Guillaubey A, Bron AM, Berrod JP, Creuzot-Garcher C. Long-term outcome of idiopathic macular hole surgery. Am J Ophthalmol. 2010 Jan;149(1):120-6. doi: 10.1016/j.ajo.2009.08.003. Epub 2009 Oct 20.
PubMed 19846059
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome of Idiopathic Macular Hole Surgery
- ClinicalTrials.gov ID
- NCT00941291
- Acronym / sponsor ID
- Macular hole 1
- Conditions
- Idiopathic Macular Hole
- Keywords
- idiopathic macular hole, cataract, edema, Reopening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- Jan 2005 (actual)
- First posted
- 17 Jul 2009 (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 purpose of this study is to evaluate the role of cataract surgery and cystoid macular edema (CME) on reopening of idiopathic macular holes (IMH).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| vitrectomy in pseudophakic eyes | – | – |
| vitrectomy and cataract:combined procedure | – | – |
| vitrectomy followed by cataract extraction | – | – |
| vitrectomy on phakic eyes | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred and thirty patients (135 eyes) with stage 2, 3, or 4 IMH were included after successful IMH repair
Key inclusion criteria (1 listed)
- Patients with with stage 2, 3, or 4 Idiopathic Macular Hole after successful Idiopathic Macular Hole repair
Key exclusion criteria (1 listed)
- All patients without stage 2, 3, or 4 Idiopathic Macular Hole repair
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
Long-term outcome of idiopathic macular hole surgery
Time frame: 37 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 17 Jul 2009.
- Derived from this study: PubMed 19846059Passemard M, Yakoubi Y, Muselier A, Hubert I, Guillaubey A, Bron AM, Berrod JP, Creuzot-Garcher C. Long-term outcome of idiopathic macular hole surgery. Am J Ophthalmol. 2010 Jan;149(1):120-6. doi: 10.1016/j.ajo.2009.08.003. Epub 2009 Oct 20.
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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.
Catherine Creuzot-Gracher, MD, PhD principal investigator
Ophthalmology unit CHU Dijon
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 Idiopathic Macular Hole, run by Centre Hospitalier Universitaire Dijon 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 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 17 Jul 2009. 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?
Long-term outcome of idiopathic macular hole surgery (time frame: 37 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00941291, which also lists 1 linked publication.
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 17 Jul 2009.