Macular HoleNCT01069029
Combined Versus Successive Macular Hole and Cataract Surgery
An observational study of Macular Hole and Visual Acuity, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The purpose of this study is to compare functional and anatomical results of a combined surgery and two time surgery for macular hole and cataract extraction in one hundred and twenty patients (120 eyes) with idiopathic Macular Hole (MH) and cataract in two academic centers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Macular Hole, Visual Acuity
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2006to Dec 2007
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with symptomatic visual loss and needed vitrectomy for Macular Hole treatment.
Who may be able to join
- Macular Hole Stage 2,3,and 4
- Visual loss
- At least 18 years of age
Who cannot join
- Stage of Macular Hole Stage 1
- Macular hole post traumatism or associated with retinal detachment
- Diabetic retinopathy
- Glaucoma
- Age-related macular degeneration
- Myopia > 6 diopters
- Preoperative pseudophakia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Macular Hole and Cataract Extraction: Combined Surgery Versus Two Times Surgery
The purpose of this study is to compare functional and anatomical results of a combined surgery and two time surgery for macular hole and cataract extraction in one hundred and twenty patients (120 eyes) with idiopathic Macular Hole (MH) and cataract in two academic centers.
Read the detailed description
Main outcome measures were the assessment of visual acuity at 6 and 12 months,and the rate of closure of MH by OCT (optical coherence tomography).
- Conditions
- Macular Hole, Visual Acuity
- Keywords
- Macular Hole, Cataract surgery, Vitreoretinal surgery, Combined surgery, Idiopathic
- Medical subject headings
- Retinal Perforations
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 |
|---|---|---|
| Combined surgery | Patient which underwent combined surgery of MH and cataract extraction | |
| Successive surgery | Patients which underwent the two successive procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post surgical procedure assessment of Visual acuity
Measured: 6 and 12 months post surgery
Secondary outcomes (1)
Rate of closure of macular hole by OCT
Measured: at 6 and 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startJan 2006
- Primary completionDec 2007
- Study completionDec 2007
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 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
- 120 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
- NCT01069029
- Sponsor's protocol ID
- Aurore 1
- Status last verified
- Jan 2006
- First submitted
- 16 Feb 2010
- Last updated
- 17 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Muselier A, Dugas B, Burelle X, Passemard M, Hubert I, Mathieu B, Berrod JP, Bron AM, Creuzot-Garcher C. Macular hole surgery and cataract extraction: combined vs consecutive surgery. Am J Ophthalmol. 2010 Sep;150(3):387-91. doi: 10.1016/j.ajo.2010.04.008. Epub 2010 Jul 7.
PubMed 20615492
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Hole and Cataract Extraction: Combined Surgery Versus Two Times Surgery
- ClinicalTrials.gov ID
- NCT01069029
- Acronym / sponsor ID
- Aurore 1
- Conditions
- Macular Hole, Visual Acuity
- Keywords
- Macular Hole, Cataract surgery, Vitreoretinal surgery, Combined surgery, Idiopathic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 17 Feb 2010 (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 compare functional and anatomical results of a combined surgery and two time surgery for macular hole and cataract extraction in one hundred and twenty patients (120 eyes) with idiopathic Macular Hole (MH) and cataract in two academic centers.
Detailed description
Main outcome measures were the assessment of visual acuity at 6 and 12 months,and the rate of closure of MH by OCT (optical coherence tomography).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined surgery | – | –Patient which underwent combined surgery of MH and cataract extraction |
| Successive surgery | – | –Patients which underwent the two successive procedures |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with symptomatic visual loss and needed vitrectomy for Macular Hole treatment.
Key inclusion criteria (3 listed)
- Macular Hole Stage 2,3,and 4
- Visual loss
- At least 18 years of age
Key exclusion criteria (7 listed)
- Stage of Macular Hole Stage 1
- Macular hole post traumatism or associated with retinal detachment
- Diabetic retinopathy
- Glaucoma
- Age-related macular degeneration
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
Post surgical procedure assessment of Visual acuity
Time frame: 6 and 12 months post surgery
1 secondary outcome
Rate of closure of macular hole by OCT
Time frame: at 6 and 12 months post 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 17 Feb 2010.
- Derived from this study: PubMed 20615492Muselier A, Dugas B, Burelle X, Passemard M, Hubert I, Mathieu B, Berrod JP, Bron AM, Creuzot-Garcher C. Macular hole surgery and cataract extraction: combined vs consecutive surgery. Am J Ophthalmol. 2010 Sep;150(3):387-91. doi: 10.1016/j.ajo.2010.04.008. Epub 2010 Jul 7.
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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 Macular Hole and Visual Acuity, 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 3 inclusion and 7 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 Feb 2010. 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?
Post surgical procedure assessment of Visual acuity (time frame: 6 and 12 months post surgery). 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 NCT01069029, 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 Feb 2010.