Epiretinal Macular MembraneNCT00851760
Epiretinal Macular Membrane and Cataract Extraction
A study testing Consecutive surgery and Combined surgery in people with Epiretinal Macular Membrane and Cataract Extraction, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The investigators proposed to assess the functional and anatomical outcomes of cataract and idiopathic epiretinal macular membrane extraction in combined and consecutive surgeries. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Epiretinal Macular Membrane, Cataract Extraction
- What is being tested?
- Consecutive surgery and Combined surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2005to Sep 2007
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients had symptomatic visual loss and needed vitrectomy for ERM removal.
Who cannot join
- Patients suffering from ERM secondary to uveitis, trauma, or associated with a simultaneous RD were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Idiopathic Epiretinal Macular Membrane and Cataract Extraction : Combined vs Consecutive Surgery
The investigators proposed to assess the functional and anatomical outcomes of cataract and idiopathic epiretinal macular membrane extraction in combined and consecutive surgeries.
Read the detailed description
A retrospective nonrandomized clinical case series study collected 174 consecutive eyes of 174 patients undergoing macular surgery between January 2005 and December 2006. Patients suffering from epiretinal macular membranes (ERM) secondary to uveitis, trauma, or associated with a simultaneous retinal detachment (RD) were excluded. We treated 109 eyes with a combined procedure (group 1) and 65 eyes with a consecutive surgery (membrane surgery and cataract separately)(group 2).
- Conditions
- Epiretinal Macular Membrane, Cataract Extraction
- Being tested
- Consecutive surgery, Combined surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consecutive surgeryProcedure or surgery
Consecutive surgery for epiretinal macular membrane and cataract extraction
Combined surgeryProcedure or surgery
Combined surgery for epiretinal macular membrane and cataract extraction
| Study group | Role | What they receive |
|---|---|---|
| 1 Combined Surgery | Experimental | Not described Receives: Procedure: Combined surgery |
| 2 consecutive surgery | Active comparator | Not described Receives: Procedure: Consecutive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined and consecutive surgeries are effective procedures to treat idiopathic ERM. The functional and anatomical results are equivalent in both procedures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startJan 2005
- Primary completionDec 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal Macular MembraneStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851760
- Sponsor's protocol ID
- CHU Dijon OPH 01
- Status last verified
- Aug 2009
- First submitted
- 25 Feb 2009
- Last updated
- 4 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Epiretinal Macular Membrane and Cataract Extraction : Combined vs Consecutive Surgery
- ClinicalTrials.gov ID
- NCT00851760
- Acronym / sponsor ID
- CHU Dijon OPH 01
- Conditions
- Epiretinal Macular Membrane, Cataract Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 26 Feb 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 investigators proposed to assess the functional and anatomical outcomes of cataract and idiopathic epiretinal macular membrane extraction in combined and consecutive surgeries.
Detailed description
A retrospective nonrandomized clinical case series study collected 174 consecutive eyes of 174 patients undergoing macular surgery between January 2005 and December 2006. Patients suffering from epiretinal macular membranes (ERM) secondary to uveitis, trauma, or associated with a simultaneous retinal detachment (RD) were excluded. We treated 109 eyes with a combined procedure (group 1) and 65 eyes with a consecutive surgery (membrane surgery and cataract separately)(group 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Combined Surgery | Experimental | Procedure: Combined surgery |
| 2 consecutive surgery | Active comparator | Procedure: Consecutive surgery |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients had symptomatic visual loss and needed vitrectomy for ERM removal.
Key exclusion criteria (1 listed)
- Patients suffering from ERM secondary to uveitis, trauma, or associated with a simultaneous RD were excluded.
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 |
|---|---|---|
| Consecutive surgeryConsecutive surgery for epiretinal macular membrane and cataract extraction | Procedure or surgery | 2 consecutive surgery |
| Combined surgeryCombined surgery for epiretinal macular membrane and cataract extraction | Procedure or surgery | 1 Combined Surgery |
Primary outcome
Combined and consecutive surgeries are effective procedures to treat idiopathic ERM. The functional and anatomical results are equivalent in both procedures.
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 4 Aug 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consecutive surgery and Combined surgery in people with Epiretinal Macular Membrane and Cataract Extraction, 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 4 Aug 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?
Combined and consecutive surgeries are effective procedures to treat idiopathic ERM. The functional and anatomical results are equivalent in both procedures.. 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 4 Aug 2009; AzTrials last refreshed its copy on 31 Oct 2026.