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Comparison of Two Techniques for Epiretinal or Internal Limiting Membrane Peel

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ClinicalTrials.gov Identifier: NCT00892619
Recruitment Status : Unknown
Verified April 2009 by Michael E. DeBakey VA Medical Center.
Recruitment status was:  Recruiting
First Posted : May 4, 2009
Last Update Posted : May 4, 2009
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by:
Michael E. DeBakey VA Medical Center

Study Description
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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

Condition or disease Intervention/treatment Phase
Epiretinal Membrane Vitreomacular Traction Procedure: using ILM forceps alone Procedure: Breaking and peeling with end-grasping forceps Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Comparison of Two Techniques for Epiretinal or Internal Limiting Membrane Peel.
Study Start Date : December 2008
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : May 2010
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in visual acuity [ Time Frame: three months ]

Secondary Outcome Measures :
  1. Change in humphrey visual field [ Time Frame: three months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892619


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

Locations
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United States, Texas
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.         
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         
Sponsors and Collaborators
Michael E. DeBakey VA Medical Center
Baylor College of Medicine
Investigators
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Principal Investigator: Petros E Carvounis, B.M.B.Ch., F.R.C.S.C. Baylor College of Medicine, Michael Debakey VAMC
More Information
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Responsible Party: PETROS EUTHYMIOU CARVOUNIS, M.D., Baylor College of Medicine, Micheal Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00892619    
Other Study ID Numbers: h-22378
First Posted: May 4, 2009    Key Record Dates
Last Update Posted: May 4, 2009
Last Verified: April 2009
Keywords provided by Michael E. DeBakey VA Medical Center:
Epiretinal Membrane
Vitreomacular traction
MVR blade
 Tano brush
ILM forceps
surgical technique
Additional relevant MeSH terms:
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Epiretinal Membrane
Retinal Diseases
Eye Diseases