Epiretinal MembraneNCT00892619
Comparison of Two Techniques for Epiretinal or Internal Limiting Membrane Peel
A study testing using ILM forceps alone and Breaking and peeling with end-grasping forceps in people with Epiretinal Membrane and Vitreomacular Traction, run by Michael E. DeBakey VA Medical Center at 2 sites in United States.
Trial summary
Epiretinal membranes (ERM) are cellular membranes on the surface of the retina that result in distortion of the vision (metamorphopsia), and decreased best-corrected visual acuity. They are most frequently found in patients over the age of 50 and have a reported prevalence of 7-12%. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epiretinal Membrane, Vitreomacular Traction
- What is being tested?
- using ILM forceps alone and Breaking and peeling with end-grasping forceps
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Dec 2008to May 2010
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Epiretinal membrane with associated macular thickening or cystoid macular edema present;
- ETDRS best corrected visual acuity 20/50 or worse attributed to the effects of the epiretinal membrane;
- Pars plana vitrectomy/membrane peel planned for treatment of the epiretinal membrane;
- Patients older than 19 years of age;
- No co-existent retina pathology or optic neuropathy that may influence the visual field.
Who cannot join
- Patient unwilling or unable to provide informed consent;
- Co-existing retina pathology (proliferative diabetic retinopathy, central retinal vein occlusion, branch retinal vein occlusion, central/branch retinal artery occlusion, ERM secondary to trauma, prior surgery for ERM);
- Co-existing lenticular opacity;
- Optic neuropathy causing a pre-existing visual field defect involving the central 10 degrees of vision.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Anita Austin, 713-798-5756, aaustin@bcm.edu
Petros E Carvounis, B.M.B.Ch., F.R.C.S.C.
- Recruiting
Michael Debakey VAMC
Houston, Texas, 77030
Anita Austin, 713-798-5756, aaustin@bcm.edu
Petros E Carvounis, B.M.B.Ch., F.R.C.S.C.
About this study
Official title: Comparison of Two Techniques for Epiretinal or Internal Limiting Membrane Peel.
Epiretinal membranes (ERM) are cellular membranes on the surface of the retina that result in distortion of the vision (metamorphopsia), and decreased best-corrected visual acuity. They are most frequently found in patients over the age of 50 and have a reported prevalence of 7-12%. [1,2] Epiretinal membranes are caused by posterior vitreous separation, retinal detachment, proliferative vitreoretinopathy, cataract surgery, trauma, inflammation, retinal vascular disease, and idiopathic. [1-4] Epiretinal membrane removal by pars plana vitrectomy combined with internal limiting membrane peeling leads to improved vision, decreased metamorphopsia, and improved quality of life after surgery. [2] Internal limiting membrane (ILM) peel has been associated with decreased rates of epiretinal membrane recurrence and is also performed during vitrectomy for repair of macular holes or vitreomacular traction. [5,6] Internal limiting membrane peeling can be performed by using an instrument to make a break in the membrane followed by peeling with forceps, or by utilizing ILM forceps alone to pinch and peel an unviolated ILM. No study exists comparing different intraoperative techniques used for ILM peeling on visual outcomes and operating time. The investigators hypothesize that using a "pinch and peel" technique will equal outcomes with shorter operating time than other techniques.
- McDonald HR, Johnson RN, Ai E, Jumper JM, Fu AD. Macular epiretinal membranes. Retina, 4th edition, editor Ryan SJ, Wilkinson CP, 2006, p 2509-2525.
- Ghazi-Nouri SM, Tranos PG, Rubin GS, Adams ZC, Charteris DG. Vitrectomy and epiretinal membrane peel surgery visual function and quality of life following. 2006;90;559-562; Br. J. Ophthalmol
- Haritoglu C, Gandorfer A, Gass CA, Schaumberger M, Ulbig MW, Kampik A. The Effect of Indocyanine-Green on Functional Outcome of Macular Pucker Surgery. AM. J. Ophthal. VOL. 135,NO.3, 328-337, Mar 2003
- Hiscott PS, Grierson I, McLeod D. Retinal pigment epithelial cells in epiretinal membranes: an immunohistochemical study. Br. J. Ophthalmol, 1984, 68, 708-715
- Park DW, Dugel PU, Garda J, Sipperley JO, Thach A, Sneed SR, Blaisdell J. Macular Pucker Removal with and without Internal Limiting Membrane Peeling: Pilot Study. Ophthalmology Volume 110, 1, Jan 2003
- Kwok AK, Lai TY, Yuen KS. Epiretinal membrane surgery with or without internal limiting membrane peeling. Clinical and Experimental Ophthalmology, 2005, 33:379-385
- Conditions
- Epiretinal Membrane, Vitreomacular Traction
- Being tested
- using ILM forceps alone, Breaking and peeling with end-grasping forceps
- Keywords
- Epiretinal Membrane, Vitreomacular traction, MVR blade, Tano brush, ILM forceps, surgical technique
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using ILM forceps aloneProcedure or surgery
Using ILM forceps to initiate and complete ILM peel
Breaking and peeling with end-grasping forcepsProcedure or surgery
Using an instrument to create a break in the ILM followed by peeling of the membrane with end-grasping forceps
| Study group | Role | What they receive |
|---|---|---|
| ILM forceps | Experimental | Using ILM forceps to initiate and complete peel Receives: Procedure: using ILM forceps alone |
| Other | Active comparator | Using an instrument to create a break in the ILM followed by peeling of the membrane with end-grasping forceps Receives: Procedure: Breaking and peeling with end-grasping forceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual acuity
Measured: three months
Secondary outcomes (1)
Change in humphrey visual field
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2010 (estimated)
- Study completionMay 2010 (estimated)
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
Sponsor and investigators
- Lead sponsor
- Michael E. DeBakey VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Baylor College of Medicine
- Investigators
- Petros E Carvounis, B.M.B.Ch., F.R.C.S.C., Principal investigator, Baylor College of Medicine, Michael Debakey VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892619
- Sponsor's protocol ID
- h-22378
- Status last verified
- Apr 2009
- First submitted
- 30 Apr 2009
- Last updated
- 4 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Techniques for Epiretinal or Internal Limiting Membrane Peel.
- ClinicalTrials.gov ID
- NCT00892619
- Acronym / sponsor ID
- h-22378
- Conditions
- Epiretinal Membrane, Vitreomacular Traction
- Keywords
- Epiretinal Membrane, Vitreomacular traction, MVR blade, Tano brush, ILM forceps, surgical technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Michael E. DeBakey VA Medical CenterUS federal agency
- Collaborators
- Baylor College of Medicine
- Study start
- Dec 2008
- Primary completion
- Mar 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 4 May 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.
Epiretinal membranes (ERM) are cellular membranes on the surface of the retina that result in distortion of the vision (metamorphopsia), and decreased best-corrected visual acuity. They are most frequently found in patients over the age of 50 and have a reported prevalence of 7-12%. [1,2] Epiretinal membranes are caused by posterior vitreous separation, retinal detachment, proliferative vitreoretinopathy, cataract surgery, trauma, inflammation, retinal vascular disease, and idiopathic. [1-4] Epiretinal membrane removal by pars plana vitrectomy combined with internal limiting membrane peeling leads to improved vision, decreased metamorphopsia, and improved quality of life after surgery. [2] Internal limiting membrane (ILM) peel has been associated with decreased rates of epiretinal membrane recurrence and is also performed during vitrectomy for repair of macular holes or vitreomacular traction. [5,6] Internal limiting membrane peeling can be performed by using an instrument to make a break in the membrane followed by peeling with forceps, or by utilizing ILM forceps alone to pinch and peel an unviolated ILM. No study exists comparing different intraoperative techniques used for ILM peeling on visual outcomes and operating time. The investigators hypothesize that using a "pinch and peel" technique will equal outcomes with shorter operating time than other techniques.
- McDonald HR, Johnson RN, Ai E, Jumper JM, Fu AD. Macular epiretinal membranes. Retina, 4th edition, editor Ryan SJ, Wilkinson CP, 2006, p 2509-2525.
- Ghazi-Nouri SM, Tranos PG, Rubin GS, Adams ZC, Charteris DG. Vitrectomy and epiretinal membrane peel surgery visual function and quality of life following. 2006;90;559-562; Br. J. Ophthalmol
- Haritoglu C, Gandorfer A, Gass CA, Schaumberger M, Ulbig MW, Kampik A. The Effect of Indocyanine-Green on Functional Outcome of Macular Pucker Surgery. AM. J. Ophthal. VOL. 135,NO.3, 328-337, Mar 2003
- Hiscott PS, Grierson I, McLeod D. Retinal pigment epithelial cells in epiretinal membranes: an immunohistochemical study. Br. J. Ophthalmol, 1984, 68, 708-715
- Park DW, Dugel PU, Garda J, Sipperley JO, Thach A, Sneed SR, Blaisdell J. Macular Pucker Removal with and without Internal Limiting Membrane Peeling: Pilot Study. Ophthalmology Volume 110, 1, Jan 2003
- Kwok AK, Lai TY, Yuen KS. Epiretinal membrane surgery with or without internal limiting membrane peeling. Clinical and Experimental Ophthalmology, 2005, 33:379-385
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ILM forceps | Experimental | Procedure: using ILM forceps aloneUsing ILM forceps to initiate and complete peel |
| Other | Active comparator | Procedure: Breaking and peeling with end-grasping forcepsUsing an instrument to create a break in the ILM followed by peeling of the membrane with end-grasping forceps |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Epiretinal membrane with associated macular thickening or cystoid macular edema present;
- ETDRS best corrected visual acuity 20/50 or worse attributed to the effects of the epiretinal membrane;
- Pars plana vitrectomy/membrane peel planned for treatment of the epiretinal membrane;
- Patients older than 19 years of age;
- No co-existent retina pathology or optic neuropathy that may influence the visual field.
Key exclusion criteria (4 listed)
- Patient unwilling or unable to provide informed consent;
- Co-existing retina pathology (proliferative diabetic retinopathy, central retinal vein occlusion, branch retinal vein occlusion, central/branch retinal artery occlusion, ERM secondary to trauma, prior surgery for ERM);
- Co-existing lenticular opacity;
- Optic neuropathy causing a pre-existing visual field defect involving the central 10 degrees of vision.
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 |
|---|---|---|
| using ILM forceps aloneUsing ILM forceps to initiate and complete ILM peel | Procedure or surgery | ILM forceps |
| Breaking and peeling with end-grasping forcepsUsing an instrument to create a break in the ILM followed by peeling of the membrane with end-grasping forceps | Procedure or surgery | Other |
Primary outcome
Change in visual acuity
Time frame: three months
1 secondary outcome
Change in humphrey visual field
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 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.
Petros E Carvounis, B.M.B.Ch., F.R.C.S.C. principal investigator
Baylor College of Medicine, Michael Debakey VAMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing using ILM forceps alone and Breaking and peeling with end-grasping forceps in people with Epiretinal Membrane and Vitreomacular Traction, run by Michael E. DeBakey VA Medical Center at 2 sites in United States.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordan L Heffez, MD (713-798-3880, heffez@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual acuity (time frame: three months). 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 May 2009.