Randomized Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Removal

Epiretinal Membrane Clinical Trial

Official title:

A Multicentre Randomized Clinical Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Peeling

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01532765
• Other study ID #: 422-2010
• Status: Terminated
• Phase: N/A
• Start date: September 2011
• Est. completion date: March 22, 2017

Study information

• Verified date: December 2015
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Macular epiretinal membrane (ERM) is a semitranslucent, avascular, fibrocellular membrane on the inner surface along the internal limiting membrane (ILM) of the retina. ERM may cause symptomatic visual disturbances and vision loss. Since the 1970s, pars plana vitrectomy has been performed to remove the membranes with few complications, and surgical results are generally good. Recurrence rates of 5-16% have been reported. Recently, ILM peeling in ERM surgery have been popularized by a number of retrospective studies and one prospective case series to minimize the rate of ERM recurrences (16% recurrence in ERM surgery with ILM peel compares to 0% recurrence in ERM surgery without ILM peel). Surgical removal of the friable and transparent ILM is difficult and increases the risk of trauma to the retina. In addition, indocyanine green (ICG), a dye commonly used intra-operatively to enhance ILM visualization, is costly and has been shown to be toxic to the retina. The investigators study will be the first randomized-controlled multi-centred clinical trial to compare the outcomes of ERM surgery with and without ILM peeling. The results will help guide and standardize the surgical treatment of macular ERM; to minimize unnecessary surgical risks, as well as to help economize healthcare cost.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: March 22, 2017
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 18 years or older

• ERM on clinical exam and/or macular OCT

• Visual acuity of 20/40 or worse (attributable to ERM)

Exclusion Criteria:

• Prior surgery for ERM in the "study eye"

• Macular edema secondary to arterial/venous occlusion(s)

• Central serous retinopathy

• Age related macular degeneration

• Diabetic cystoid macular edema

• Proliferative Diabetic Retinopathy

• Uveitis

Related Conditions & MeSH terms

• Epiretinal Membrane

Intervention

Procedure:
• Pars plana vitrectomy and epiretinal membrane peel
23 gauge pars plana vitrectomy with diluted intravitreal triamcinolone for visualization
• ILM peel assisted by ICG
Indocyanine green dye is prepared from 25mg powder vial from AKORN INC., 10 mL diluent provided in kit. This is further diluted to final concentration of 0.5mg/mL using 50% sterile dextrose solution
• CE-IOL
Cataract extraction by phacoemulsification and insertion foldable posterior chamber intraocular lens implant

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (28)

Appiah AP, Hirose T, Kado M. A review of 324 cases of idiopathic premacular gliosis. Am J Ophthalmol. 1988 Nov 15;106(5):533-5. — View Citation

Bellhorn MB, Friedman AH, Wise GN, Henkind P. Ultrastructure and clinicopathologic correlation of idiopathic preretinal macular fibrosis. Am J Ophthalmol. 1975 Mar;79(3):366-73. — View Citation

Bovey EH, Uffer S, Achache F. Surgery for epimacular membrane: impact of retinal internal limiting membrane removal on functional outcome. Retina. 2004 Oct;24(5):728-35. — View Citation

Burk SE, Da Mata AP, Snyder ME, Rosa RH Jr, Foster RE. Indocyanine green-assisted peeling of the retinal internal limiting membrane. Ophthalmology. 2000 Nov;107(11):2010-4. — View Citation

Clarkson JG, Green WR, Massof D. A histopathologic review of 168 cases of preretinal membrane. 1977. Retina. 2005 Jul-Aug;25(5 Suppl):1-17. — View Citation

Falkner-Radler CI, Glittenberg C, Hagen S, Benesch T, Binder S. Spectral-domain optical coherence tomography for monitoring epiretinal membrane surgery. Ophthalmology. 2010 Apr;117(4):798-805. doi: 10.1016/j.ophtha.2009.08.034. Epub 2010 Jan 4. — View Citation

Fraser-Bell S, Guzowski M, Rochtchina E, Wang JJ, Mitchell P. Five-year cumulative incidence and progression of epiretinal membranes: the Blue Mountains Eye Study. Ophthalmology. 2003 Jan;110(1):34-40. — View Citation

Fraser-Bell S, Ying-Lai M, Klein R, Varma R; Los Angeles Latino Eye Study. Prevalence and associations of epiretinal membranes in latinos: the Los Angeles Latino Eye Study. Invest Ophthalmol Vis Sci. 2004 Jun;45(6):1732-6. — View Citation

Gale JS, Proulx AA, Gonder JR, Mao AJ, Hutnik CM. Comparison of the in vitro toxicity of indocyanine green to that of trypan blue in human retinal pigment epithelium cell cultures. Am J Ophthalmol. 2004 Jul;138(1):64-9. — View Citation

Grewing R, Mester U. Results of surgery for epiretinal membranes and their recurrences. Br J Ophthalmol. 1996 Apr;80(4):323-6. — View Citation

Hirokawa H, Jalkh AE, Takahashi M, Takahashi M, Trempe CL, Schepens CL. Role of the vitreous in idiopathic preretinal macular fibrosis. Am J Ophthalmol. 1986 Feb 15;101(2):166-9. — View Citation

Kawasaki R, Wang JJ, Sato H, Mitchell P, Kato T, Kawata S, Kayama T, Yamashita H, Wong TY. Prevalence and associations of epiretinal membranes in an adult Japanese population: the Funagata study. Eye (Lond). 2009 May;23(5):1045-51. doi: 10.1038/eye.2008.238. Epub 2008 Aug 8. — View Citation

Klein R, Klein BE, Wang Q, Moss SE. The epidemiology of epiretinal membranes. Trans Am Ophthalmol Soc. 1994;92:403-25; discussion 425-30. — View Citation

Kwok AKh, Lai TY, Yuen KS. Epiretinal membrane surgery with or without internal limiting membrane peeling. Clin Exp Ophthalmol. 2005 Aug;33(4):379-85. — View Citation

Lee JW, Kim IT. Outcomes of idiopathic macular epiretinal membrane removal with and without internal limiting membrane peeling: a comparative study. Jpn J Ophthalmol. 2010 Mar;54(2):129-34. doi: 10.1007/s10384-009-0778-0. Epub 2010 Apr 18. — View Citation

Lim JW, Kim HK, Cho DY. Macular function and ultrastructure of the internal limiting membrane removed during surgery for idiopathic epiretinal membrane. Clin Exp Ophthalmol. 2011 Jan;39(1):9-14. doi: 10.1111/j.1442-9071.2010.02377.x. — View Citation

Michels RG. A clinical and histopathologic study of epiretinal membranes affecting the macula and removed by vitreous surgery. Trans Am Ophthalmol Soc. 1982;80:580-656. Review. — View Citation

Mitchell P, Smith W, Chey T, Wang JJ, Chang A. Prevalence and associations of epiretinal membranes. The Blue Mountains Eye Study, Australia. Ophthalmology. 1997 Jun;104(6):1033-40. — View Citation

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. 2003 Jan;110(1):62-4. — View Citation

Puliafito CA, Hee MR, Lin CP, Reichel E, Schuman JS, Duker JS, Izatt JA, Swanson EA, Fujimoto JG. Imaging of macular diseases with optical coherence tomography. Ophthalmology. 1995 Feb;102(2):217-29. — View Citation

Shimada H, Nakashizuka H, Hattori T, Mori R, Mizutani Y, Yuzawa M. Double staining with brilliant blue G and double peeling for epiretinal membranes. Ophthalmology. 2009 Jul;116(7):1370-6. doi: 10.1016/j.ophtha.2009.01.024. Epub 2009 May 8. — View Citation

Sidd RJ, Fine SL, Owens SL, Patz A. Idiopathic preretinal gliosis. Am J Ophthalmol. 1982 Jul;94(1):44-8. — View Citation

Smiddy WE, Maguire AM, Green WR, Michels RG, de la Cruz Z, Enger C, Jaeger M, Rice TA. Idiopathic epiretinal membranes. Ultrastructural characteristics and clinicopathologic correlation. Ophthalmology. 1989 Jun;96(6):811-20; discussion 821. — View Citation

Ting FS, Kwok AK. Treatment of epiretinal membrane: an update. Hong Kong Med J. 2005 Dec;11(6):496-502. Review. — View Citation

Wise GN. Preretinal macular fibrosis. (An analysis of 90 cases). Trans Ophthalmol Soc U K. 1972;92:131-40. — View Citation

Wise GN. Relationship of idiopathic preretinal macular fibrosis to posterior vitreous detachment. Am J Ophthalmol. 1975 Mar;79(3):358-62. — View Citation

Wiznia RA. Posterior vitreous detachment and idiopathic preretinal macular gliosis. Am J Ophthalmol. 1986 Aug 15;102(2):196-8. — View Citation

Yuen D, Gonder J, Proulx A, Liu H, Hutnik C. Comparison of the in vitro safety of intraocular dyes using two retinal cell lines: a focus on brilliant blue G and indocyanine green. Am J Ophthalmol. 2009 Feb;147(2):251-259.e2. doi: 10.1016/j.ajo.2008.08.031. Epub 2008 Nov 7. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in macular thickness on optical coherence tomography at 6 months post-surgery (intervention)		Comparing change at 6 months following surgery and baseline
Primary	Change from baseline in visual acuity at 6 months post-surgery (intervention)		Comparing change of visual acuity at 6 months following surgery and baseline
Secondary	Change from baseline in macular thickness on optical coherence tomography at 1 month post-surgery (intervention)		1 month following surgery
Secondary	Change from baseline in macular thickness on optical coherence tomography at 12 months post-surgery		12 months following surgery
Secondary	Change from baseline in visual acuity at 1 month post-surgery (intervention)		1 month following surgery (intervention)
Secondary	Change from baseline in visual acuity at 3 months post-surgery (intervention)		3 months following surgery (intervention)
Secondary	Change from baseline in visual acuity at 12 months post-surgery (intervention)		12 months following surgery (intervention)
Secondary	Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 1 month post-surgery (intervention)		1 month following surgery (intervention)
Secondary	Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 3 months post-surgery (intervention)		3 months following surgery
Secondary	Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 6 months post-surgery (intervention)		6 months following surgery
Secondary	Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 12 months post-surgery (intervention)		12 months following surgery