Comparison of Two Techniques for Epiretinal or Internal Limiting Membrane Peel

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

Interventions

PROCEDURE

using ILM forceps alone

Using ILM forceps to initiate and complete ILM peel

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

Sponsors & Collaborators

• Baylor College of Medicine

  collaborator OTHER

• Michael E. DeBakey VA Medical Center

  lead FED

Principal Investigators

• Petros E Carvounis, B.M.B.Ch., F.R.C.S.C. · Baylor College of Medicine, Michael Debakey VAMC

Study Design

Allocation

RANDOMIZED

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-12-31

Primary Completion

2010-03-31

Completion

2010-05-31

Countries

• United States

Study Locations