Comparison of Two Techniques for Epiretinal or Internal Limiting Membrane Peel

NCT ID: NCT00892619

Last Updated: 2009-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-05-31

Brief 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%. [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.

1. 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.

2. 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

3. 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

4. Hiscott PS, Grierson I, McLeod D. Retinal pigment epithelial cells in epiretinal membranes: an immunohistochemical study. Br. J. Ophthalmol, 1984, 68, 708-715

5. 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

6. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

ILM forceps

Using ILM forceps to initiate and complete peel

Group Type: EXPERIMENTAL

using ILM forceps alone

Intervention Type: PROCEDURE

Using ILM forceps to initiate and complete ILM peel

Other

Using an instrument to create a break in the ILM followed by peeling of the membrane with end-grasping forceps

Group Type: ACTIVE_COMPARATOR

Breaking and peeling with end-grasping forceps

Intervention Type: PROCEDURE

Using an instrument to create a break in the ILM followed by peeling of the membrane with end-grasping forceps

Interventions

using ILM forceps alone

Using ILM forceps to initiate and complete ILM peel

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

Michael E. DeBakey VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Baylor College of Medicine, Micheal Debakey Veterans Affairs Medical Center

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine, Michael Debakey VAMC

Locations

Baylor College of Medicine

Houston, Texas, United States

Site Status: RECRUITING

Michael Debakey VAMC

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jordan L Heffez, MD

Role: CONTACT

heffez@bcm.edu

713-798-3880

Anita Austin

Role: CONTACT

aaustin@bcm.tmc.edu

713-798-5756

Facility Contacts

Anita Austin

Role: primary

aaustin@bcm.edu

713-798-5756

Anita Austin

Role: primary

aaustin@bcm.edu

713-798-5756

Other Identifiers

h-22378

Identifier Type: -

Identifier Source: org_study_id