Comparison of Two Techniques for Epiretinal or Internal Limiting Membrane Peel

April 30, 2009 updated by: Michael E. DeBakey VA Medical Center

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.

  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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jordan L Heffez, MD
  • Phone Number: 713-798-3880
  • Email: heffez@bcm.edu

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
        • Principal Investigator:
          • Petros E Carvounis, B.M.B.Ch., F.R.C.S.C.
      • Houston, Texas, United States, 77030
        • Recruiting
        • Michael Debakey VAMC
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ILM forceps
Using ILM forceps to initiate and complete peel
Procedure: using ILM forceps alone
Using ILM forceps to initiate and complete ILM peel
Active Comparator: Other
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in visual acuity
Time Frame: three months
three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in humphrey visual field
Time Frame: three months
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael E. DeBakey VA Medical Center

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

April 30, 2009

First Submitted That Met QC Criteria

April 30, 2009

First Posted (Estimate)

May 4, 2009

Study Record Updates

Last Update Posted (Estimate)

May 4, 2009

Last Update Submitted That Met QC Criteria

April 30, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • h-22378

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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