Comparison of Two Techniques for Epiretinal or Internal Limiting Membrane Peel - Full Text View

Sponsor:	Michael Debakey Veterans Affairs Medical Center
Collaborator:	Baylor College of Medicine
Information provided by:	Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:	NCT00892619

Purpose

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.

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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

Condition	Intervention
Epiretinal Membrane Vitreomacular Traction	Procedure: using ILM forceps alone Procedure: Breaking and peeling with end-grasping forceps

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Subject), Parallel Assignment
Official Title:	Comparison of Two Techniques for Epiretinal or Internal Limiting Membrane Peel.

Resource links provided by NLM:

MedlinePlus related topics: Surgery

U.S. FDA Resources

Further study details as provided by Michael Debakey Veterans Affairs Medical Center:

Primary Outcome Measures:

Change in visual acuity [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in humphrey visual field [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Study Start Date:	December 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ILM forceps: Experimental Using ILM forceps to initiate and complete peel	Procedure: using ILM forceps alone Using ILM forceps to initiate and complete ILM peel
Other: Active Comparator Using an instrument to create a break in the ILM followed by peeling of the membrane with end-grasping forceps	Procedure: Breaking and peeling with end-grasping forceps Using an instrument to create a break in the ILM followed by peeling of the membrane with end-grasping forceps

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892619

Contacts

Contact: Jordan L Heffez, MD	713-798-3880	heffez@bcm.edu
Contact: Anita Austin	713-798-5756	aaustin@bcm.tmc.edu

Locations

United States, Texas
Michael Debakey VAMC	Recruiting
Houston, Texas, United States, 77030
Contact: Anita Austin 713-798-5756 aaustin@bcm.edu
Principal Investigator: Petros E Carvounis, B.M.B.Ch., F.R.C.S.C.
Sub-Investigator: Jordan L Heffez, MD
Sub-Investigator: Andrew J Barkmeier, MD
Baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Contact: Anita Austin 713-798-5756 aaustin@bcm.edu
Principal Investigator: Petros E Carvounis, B.M.B.Ch., F.R.C.S.C.

Sponsors and Collaborators

Michael Debakey Veterans Affairs Medical Center

Baylor College of Medicine

Investigators

Principal Investigator:

Petros E Carvounis, B.M.B.Ch., F.R.C.S.C.

Baylor College of Medicine, Michael Debakey VAMC

More Information

No publications provided

Responsible Party:	Baylor College of Medicine, Micheal Debakey Veterans Affairs Medical Center ( PETROS EUTHYMIOU CARVOUNIS, M.D. )
Study ID Numbers:	h-22378
Study First Received:	April 30, 2009
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00892619 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Michael Debakey Veterans Affairs Medical Center:

Epiretinal Membrane
Vitreomacular traction
MVR blade

Tano brush
ILM forceps
surgical technique

Additional relevant MeSH terms:

Eye Diseases
Epiretinal Membrane
Retinal Diseases

ClinicalTrials.gov processed this record on February 08, 2010