Epiretinal MembraneNCT01771939
Phacoemulsification and 25 Gauge (25G) Vitrectomy Versus Phacoemulsification Only in Idiopathic Epiretinal Membranes
A study testing 25-G vitrectomy and phacoemulsification and phacoemulsification (cataract surgery) in people with Epiretinal Membrane, run by University of Turin, Italy at 1 site in Italy.
Trial summary
The purpose of the study is to evaluate the difference in Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, oct retinal thickness and microperimetry in 2 groups of 30 eyes each affected by idiopathic epiretinal membranes that underwent phacoemulsification and 25G pars-plana vitrectomy with internal… Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Epiretinal Membrane
- What is being tested?
- 25-G vitrectomy and phacoemulsification and phacoemulsification (cataract surgery)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2006to Jul 2012
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Idiopathic epiretinal membranes symptomatic
Who cannot join
- Absence of ocular symptoms, previous retinal interventions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Morphologic and Functional Results After Phacoemulsification and 25 Gauge Vitrectomy Versus Phacoemulsification Only in Eyes Affected by Idiopathic Epiretinal Membranes
The purpose of the study is to evaluate the difference in Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, oct retinal thickness and microperimetry in 2 groups of 30 eyes each affected by idiopathic epiretinal membranes that underwent phacoemulsification and 25G pars-plana vitrectomy with internal limiting membrane (ILM) peeling (Group 1) versus phacoemulsification only (Group 2), with a follow-up length up to 5 years.
Read the detailed description
Idiopathic epiretinal membranes represent a common cause of visual loss in elderly population. Vitrectomy with membrane peeling is nowadays considered the gold standard in the management of such pathology, with very good results either at short-time or at long-time follow up. In case of mild visual impairment due to epiretinal membrane and associated cataract, it is reasonable to treat only the lens pathology (with phacoemulsification and intra-ocular lens (IOL) implantation). In case of symptoms or ophthalmoscopic finding worsening it is always possible to submit patients who only underwent cataract surgery to vitrectomy with membrane peeling. There are, by now, no comparative studies between these two different approaches in medical literature.
- Conditions
- Epiretinal Membrane
- Being tested
- 25-G vitrectomy and phacoemulsification, phacoemulsification (cataract surgery)
- Keywords
- Idiopathic epiretinal membranes, 25-G surgery in idiopathic epiretinal membranes
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25-G vitrectomy and phacoemulsificationProcedure or surgery
25-G vitrectomy with Internal Limiting Membrane peeling and phacoemulsification (cataract intervention)
phacoemulsification (cataract surgery)Procedure or surgery
lens extraction after phacoemulsification and intra-ocular artificial lens implantation
| Study group | Role | What they receive |
|---|---|---|
| idiopathic epiretinal membranes | Experimental | Patients in first arm, with worse visual condition, treated with 25-G Vitrectomy and phacoemulsification (cataract intervention) Receives: Procedure: 25-G vitrectomy and phacoemulsification |
| idiopathic epiretinal membrane | Active comparator | Patient in second arm, with better pre-operative condition, treated with phacoemulsification (cataract intervention) only Receives: Procedure: phacoemulsification (cataract surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity (using LogMar scale) changes from baseline to pre-defined periods after surgery
We observed how did the visual acuity (using LogMar scale) increase after the two different surgical approaches described.
Measured: within 90,180,360,1360 days after surgery
Secondary outcomes (1)
Microperimetry parameters and average macular thickness changes
We evaluated average sensitivity (SM) and local defect (DL) using microperimetry. We also evaluated the average macular thickness using optical coherence tomography technology.
Measured: within 90,180,360,1360 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startOct 2006
- Primary completionNov 2006
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Dal Vecchio, University of Turin, Italy
- Investigators
- Marco Dal Vecchio, MD, Principal investigator, Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy 10100Antonio M. Fea, MD, PhD, Study chair, Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, ItalyCarlo A Lavia, MD, Principal investigator, Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771939
- Sponsor's protocol ID
- VTCMER2
- Status last verified
- Jan 2013
- First submitted
- 13 Dec 2012
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphologic and Functional Results After Phacoemulsification and 25 Gauge Vitrectomy Versus Phacoemulsification Only in Eyes Affected by Idiopathic Epiretinal Membranes
- ClinicalTrials.gov ID
- NCT01771939
- Acronym / sponsor ID
- VTCMER2
- Conditions
- Epiretinal Membrane
- Keywords
- Idiopathic epiretinal membranes, 25-G surgery in idiopathic epiretinal membranes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 18 Jan 2013 (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 the study is to evaluate the difference in Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, oct retinal thickness and microperimetry in 2 groups of 30 eyes each affected by idiopathic epiretinal membranes that underwent phacoemulsification and 25G pars-plana vitrectomy with internal limiting membrane (ILM) peeling (Group 1) versus phacoemulsification only (Group 2), with a follow-up length up to 5 years.
Detailed description
Idiopathic epiretinal membranes represent a common cause of visual loss in elderly population. Vitrectomy with membrane peeling is nowadays considered the gold standard in the management of such pathology, with very good results either at short-time or at long-time follow up. In case of mild visual impairment due to epiretinal membrane and associated cataract, it is reasonable to treat only the lens pathology (with phacoemulsification and intra-ocular lens (IOL) implantation). In case of symptoms or ophthalmoscopic finding worsening it is always possible to submit patients who only underwent cataract surgery to vitrectomy with membrane peeling. There are, by now, no comparative studies between these two different approaches in medical literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| idiopathic epiretinal membranes | Experimental | Procedure: 25-G vitrectomy and phacoemulsificationPatients in first arm, with worse visual condition, treated with 25-G Vitrectomy and phacoemulsification (cataract intervention) |
| idiopathic epiretinal membrane | Active comparator | Procedure: phacoemulsification (cataract surgery)Patient in second arm, with better pre-operative condition, treated with phacoemulsification (cataract intervention) only |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Idiopathic epiretinal membranes symptomatic
Key exclusion criteria (1 listed)
- Absence of ocular symptoms, previous retinal interventions
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 |
|---|---|---|
| 25-G vitrectomy and phacoemulsification25-G vitrectomy with Internal Limiting Membrane peeling and phacoemulsification (cataract intervention) | Procedure or surgery | idiopathic epiretinal membranes |
| phacoemulsification (cataract surgery)lens extraction after phacoemulsification and intra-ocular artificial lens implantation | Procedure or surgery | idiopathic epiretinal membrane |
Primary outcome
Visual acuity (using LogMar scale) changes from baseline to pre-defined periods after surgery
Time frame: within 90,180,360,1360 days after surgery
We observed how did the visual acuity (using LogMar scale) increase after the two different surgical approaches described.
1 secondary outcome
Microperimetry parameters and average macular thickness changes
Time frame: within 90,180,360,1360 days 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 18 Jan 2013.
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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.
Marco Dal Vecchio, MD principal investigator
Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy 10100
Antonio M. Fea, MD, PhD study chair
Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy
Carlo A Lavia, MD principal investigator
Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25-G vitrectomy and phacoemulsification and phacoemulsification (cataract surgery) in people with Epiretinal Membrane, run by University of Turin, Italy at 1 site in Italy.
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 18 Jan 2013. 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 Italy. 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?
Visual acuity (using LogMar scale) changes from baseline to pre-defined periods after surgery (time frame: within 90,180,360,1360 days 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 18 Jan 2013.