Ignite Creation Date:
2024-05-05 @ 9:29 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00892619
Status:
UNKNOWN
Last Update Posted:
2009-05-04
First Post:
2009-04-30
Brief Title:
Comparison of Two Techniques for Epiretinal or Internal Limiting Membrane Peel
Sponsor:
Michael E DeBakey VA Medical Center
Organization:
Michael E DeBakey VA Medical Center
Study Overview
Official Title:
Comparison of Two Techniques for Epiretinal or Internal Limiting Membrane Peel
Status:
UNKNOWN
Status Verified Date:
2009-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 12 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 56 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 200690559-562 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 135NO3 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 33379-385
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 200690559-562 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 135NO3 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 33379-385
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None