Comparison of Two Techniques for Epiretinal or Internal Limiting Membrane Peel

NCT00892619 | Unknown

• 1 other identifier: h-22378
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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. 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. 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. 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. 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. 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. 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

Keywords

Epiretinal Membrane; Vitreomacular traction; MVR blade; Tano brush; ILM forceps; surgical technique

Outcome Measures

Primary Outcomes (1)

• Change in visual acuity

  three months

Secondary Outcomes (1)

• Change in humphrey visual field

  three months

Study Arms (2)

ILM forceps

EXPERIMENTAL

Using ILM forceps to initiate and complete peel

Procedure: using ILM forceps alone

Other

ACTIVE COMPARATOR

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

Interventions

using ILM forceps alone PROCEDURE

Using ILM forceps to initiate and complete ILM peel

ILM forceps

Breaking and peeling with end-grasping forceps PROCEDURE

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

Other

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael E. DeBakey VA Medical Center: lead
• Baylor College of Medicine: collaborator

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Michael Debakey VAMC

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Epiretinal Membrane

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

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

  Baylor College of Medicine, Michael Debakey VAMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan L Heffez, MD

CONTACT

713-798-3880; heffez@bcm.edu

Anita Austin

CONTACT

713-798-5756; aaustin@bcm.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 4, 2009
• Study Start: December 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 4, 2009

Record last verified: 2009-04

Locations

US (2)