Comparison of Two Techniques for Epiretinal or Internal Limiting Membrane Peel

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Michael Debakey Veterans Affairs Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by:
Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00892619
First received: April 30, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  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.

  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

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

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

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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: PETROS EUTHYMIOU CARVOUNIS, M.D., Baylor College of Medicine, Micheal Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00892619     History of Changes
Other Study ID Numbers: h-22378
Study First Received: April 30, 2009
Last Updated: April 30, 2009
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:
Epiretinal Membrane
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 21, 2014