Indocyanine Green or Trypan Blue for Delamination of the Internal Limiting Membrane in Macular Hole Surgery

NCT00419185 | Completed

• 1 other identifier: UKSH
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the anatomical and visual outcomes after vitrectomy and internal limiting membrane (ILM) peeling with indocyanine green (ICG) or trypan blue (TB) for idiopathic macular hole repair in a prospective randomized trial.

Conditions

Idiopathic Macular Hole

Keywords

macular hole surgery; indocyanine green; trypan blue; internal limiting membrane

Outcome Measures

Primary Outcomes (2)

• Primary outcome was ETDRS visual acuity (VA: snellen equivalent) at two meters 3 months after surgery.

• Assignment to ICG or TB dye was performed by the Institute of Medical Biometry and Statistics of the University Luebeck per telephone immediately before surgery. Allocation to treatment arms was done with a permuted block randomization with block size 20

Secondary Outcomes (3)

• Secondary outcome measures were successful hole closure defined only as complete closure of the inner retinal dehiscence determined by OCT,

• cystoid macular edema as revealed by fluorescein angiography (FLA) and

• postoperative scotoma shown by SLO-microperimetry.

Interventions

Delamination of the Internal limiting membrane PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with idiopathic macular holes stage II-IV according to the classification proposed by Gass and a visual acuity of at least 20/200 entered this study.

You may not qualify if:

• Patients with secondary macular holes, previous intraocular surgery, except for uneventful cataract extraction and patients with ocular disorders that might interfere with vision such as severe cataract, exudative age-related macular degeneration or diabetic retinopathy.

Sponsors & Collaborators

• University of Luebeck: lead

Study Sites (1)

Eye Clinic, University Schleswig-Holstein, Campus Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Related Publications (31)

• Kadonosono K, Itoh N, Uchio E, Nakamura S, Ohno S. Staining of internal limiting membrane in macular hole surgery. Arch Ophthalmol. 2000 Aug;118(8):1116-8. doi: 10.1001/archopht.118.8.1116.

  PMID: 10922208 BACKGROUND

• Brooks HL Jr. Macular hole surgery with and without internal limiting membrane peeling. Ophthalmology. 2000 Oct;107(10):1939-48; discussion 1948-9. doi: 10.1016/s0161-6420(00)00331-6.

  PMID: 11013203 BACKGROUND

• Haritoglou C, Gass CA, Schaumberger M, Gandorfer A, Ulbig MW, Kampik A. Long-term follow-up after macular hole surgery with internal limiting membrane peeling. Am J Ophthalmol. 2002 Nov;134(5):661-6. doi: 10.1016/s0002-9394(02)01751-8.

  PMID: 12429240 BACKGROUND

• Kuhn F. Point: to peel or not to peel, that is the question. Ophthalmology. 2002 Jan;109(1):9-11. doi: 10.1016/s0161-6420(01)00992-7. No abstract available.

  PMID: 11772571 BACKGROUND

• 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. doi: 10.1016/s0161-6420(00)00375-4.

  PMID: 11054324 BACKGROUND

• Li K, Wong D, Hiscott P, Stanga P, Groenewald C, McGalliard J. Trypan blue staining of internal limiting membrane and epiretinal membrane during vitrectomy: visual results and histopathological findings. Br J Ophthalmol. 2003 Feb;87(2):216-9. doi: 10.1136/bjo.87.2.216.

  PMID: 12543755 BACKGROUND

• Enaida H, Sakamoto T, Hisatomi T, Goto Y, Ishibashi T. Morphological and functional damage of the retina caused by intravitreous indocyanine green in rat eyes. Graefes Arch Clin Exp Ophthalmol. 2002 Mar;240(3):209-13. doi: 10.1007/s00417-002-0433-7. Epub 2002 Feb 15.

  PMID: 11935278 BACKGROUND

• Gandorfer A, Haritoglou C, Gandorfer A, Kampik A. Retinal damage from indocyanine green in experimental macular surgery. Invest Ophthalmol Vis Sci. 2003 Jan;44(1):316-23. doi: 10.1167/iovs.02-0545.

  PMID: 12506091 BACKGROUND

• Sippy BD, Engelbrecht NE, Hubbard GB, Moriarty SE, Jiang S, Aaberg TM Jr, Aaberg TM Sr, Grossniklaus HE, Sternberg P Jr. Indocyanine green effect on cultured human retinal pigment epithelial cells: implication for macular hole surgery. Am J Ophthalmol. 2001 Sep;132(3):433-5. doi: 10.1016/s0002-9394(01)01061-3.

  PMID: 11530072 BACKGROUND

• Stalmans P, Van Aken EH, Veckeneer M, Feron EJ, Stalmans I. Toxic effect of indocyanine green on retinal pigment epithelium related to osmotic effects of the solvent. Am J Ophthalmol. 2002 Aug;134(2):282-5. doi: 10.1016/s0002-9394(02)01468-x.

  PMID: 12140045 BACKGROUND

• Engelbrecht NE, Freeman J, Sternberg P Jr, Aaberg TM Sr, Aaberg TM Jr, Martin DF, Sippy BD. Retinal pigment epithelial changes after macular hole surgery with indocyanine green-assisted internal limiting membrane peeling. Am J Ophthalmol. 2002 Jan;133(1):89-94. doi: 10.1016/s0002-9394(01)01293-4.

  PMID: 11755843 BACKGROUND

• Wolf S, Reichel MB, Wiedemann P, Schnurrbusch UEK. Clinical findings in macular hole surgery with indocyanine green-assisted peeling of the internal limiting membrane. Graefes Arch Clin Exp Ophthalmol. 2003 Jul;241(7):589-592. doi: 10.1007/s00417-003-0673-1. Epub 2003 May 8.

  PMID: 12736727 BACKGROUND

• Ando F, Yasui O, Hirose H, Ohba N. Optic nerve atrophy after vitrectomy with indocyanine green-assisted internal limiting membrane peeling in diffuse diabetic macular edema. Adverse effect of ICG-assisted ILM peeling. Graefes Arch Clin Exp Ophthalmol. 2004 Dec;242(12):995-9. doi: 10.1007/s00417-004-0864-4. Epub 2004 Jul 17.

  PMID: 15592868 BACKGROUND

• Gass CA, Haritoglou C, Schaumberger M, Kampik A. Functional outcome of macular hole surgery with and without indocyanine green-assisted peeling of the internal limiting membrane. Graefes Arch Clin Exp Ophthalmol. 2003 Sep;241(9):716-20. doi: 10.1007/s00417-003-0710-0. Epub 2003 Aug 13.

  PMID: 12920526 BACKGROUND

• Kwok AK, Yeung CK, Lai TY, Chan KP, Pang CP. Effects of trypan blue on cell viability and gene expression in human retinal pigment epithelial cells. Br J Ophthalmol. 2004 Dec;88(12):1590-4. doi: 10.1136/bjo.2004.044537.

  PMID: 15548818 BACKGROUND

• Lee KL, Dean S, Guest S. A comparison of outcomes after indocyanine green and trypan blue assisted internal limiting membrane peeling during macular hole surgery. Br J Ophthalmol. 2005 Apr;89(4):420-4. doi: 10.1136/bjo.2004.049684.

  PMID: 15774917 BACKGROUND

• Horio N, Horiguchi M. Effect on visual outcome after macular hole surgery when staining the internal limiting membrane with indocyanine green dye. Arch Ophthalmol. 2004 Jul;122(7):992-6. doi: 10.1001/archopht.122.7.992.

  PMID: 15249363 BACKGROUND

• Da Mata AP, Burk SE, Riemann CD, Rosa RH Jr, Snyder ME, Petersen MR, Foster RE. Indocyanine green-assisted peeling of the retinal internal limiting membrane during vitrectomy surgery for macular hole repair. Ophthalmology. 2001 Jul;108(7):1187-92. doi: 10.1016/s0161-6420(01)00593-0.

  PMID: 11425673 BACKGROUND

• Kwok AK, Lai TY, Yuen KS, Tam BS, Wong VW. Macular hole surgery with or without indocyanine green stained internal limiting membrane peeling. Clin Exp Ophthalmol. 2003 Dec;31(6):470-5. doi: 10.1046/j.1442-9071.2003.00709.x.

  PMID: 14641152 BACKGROUND

• Ando F, Sasano K, Ohba N, Hirose H, Yasui O. Anatomic and visual outcomes after indocyanine green-assisted peeling of the retinal internal limiting membrane in idiopathic macular hole surgery. Am J Ophthalmol. 2004 Apr;137(4):609-14. doi: 10.1016/j.ajo.2003.08.038.

  PMID: 15059697 BACKGROUND

• Lochhead J, Jones E, Chui D, Lake S, Karia N, Patel CK, Rosen P. Outcome of ICG-assisted ILM peel in macular hole surgery. Eye (Lond). 2004 Aug;18(8):804-8. doi: 10.1038/sj.eye.6701328.

  PMID: 14752502 BACKGROUND

• Slaughter K, Lee IL. Macular hole surgery with and without indocyanine green assistance. Eye (Lond). 2004 Apr;18(4):376-8. doi: 10.1038/sj.eye.6700666.

  PMID: 15069433 BACKGROUND

• Haritoglou C, Gass CA, Schaumberger M, Ehrt O, Gandorfer A, Kampik A. Macular changes after peeling of the internal limiting membrane in macular hole surgery. Am J Ophthalmol. 2001 Sep;132(3):363-8. doi: 10.1016/s0002-9394(01)01093-5.

  PMID: 11530049 BACKGROUND

• Paques M, Genevois O, Regnier A, Tadayoni R, Sercombe R, Gaudric A, Vicaut E. Axon-tracing properties of indocyanine green. Arch Ophthalmol. 2003 Mar;121(3):367-70. doi: 10.1001/archopht.121.3.367.

  PMID: 12617707 BACKGROUND

• Uemoto R, Yamamoto S, Takeuchi S. Changes in retinal pigment epithelium after indocyanine green-assisted internal limiting lamina peeling during macular hole surgery. Am J Ophthalmol. 2005 Oct;140(4):752-5. doi: 10.1016/j.ajo.2005.04.035.

  PMID: 16226539 BACKGROUND

• Haritoglou C, Gandorfer A, Schaumberger M, Tadayoni R, Gandorfer A, Kampik A. Light-absorbing properties and osmolarity of indocyanine-green depending on concentration and solvent medium. Invest Ophthalmol Vis Sci. 2003 Jun;44(6):2722-9. doi: 10.1167/iovs.02-1283.

  PMID: 12766079 BACKGROUND

• Rezai KA, Farrokh-Siar L, Gasyna EM, Ernest JT. Trypan blue induces apoptosis in human retinal pigment epithelial cells. Am J Ophthalmol. 2004 Sep;138(3):492-5. doi: 10.1016/j.ajo.2004.03.033.

  PMID: 15364242 BACKGROUND

• Jackson TL, Hillenkamp J, Knight BC, Zhang JJ, Thomas D, Stanford MR, Marshall J. Safety testing of indocyanine green and trypan blue using retinal pigment epithelium and glial cell cultures. Invest Ophthalmol Vis Sci. 2004 Aug;45(8):2778-85. doi: 10.1167/iovs.04-0320.

  PMID: 15277504 BACKGROUND

• 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. doi: 10.1016/j.ajo.2004.02.061.

  PMID: 15234283 BACKGROUND

• Kwok AK, Lai TY, Yew DT, Li WW. Internal limiting membrane staining with various concentrations of indocyanine green dye under air in macular surgeries. Am J Ophthalmol. 2003 Aug;136(2):223-30. doi: 10.1016/s0002-9394(02)02144-x.

  PMID: 12888042 BACKGROUND

• Beutel J, Dahmen G, Ziegler A, Hoerauf H. Internal limiting membrane peeling with indocyanine green or trypan blue in macular hole surgery: a randomized trial. Arch Ophthalmol. 2007 Mar;125(3):326-32. doi: 10.1001/archopht.125.3.326.

  PMID: 17353402 DERIVED

Study Officials

• Hans M Hoerauf, Prof.

  Eye Clinic, University Schleswig Holstein, Campus Lübeck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2007
• First Posted: January 8, 2007
• Study Start: April 1, 2003
• Study Completion: January 1, 2005
• Last Updated: January 8, 2007

Record last verified: 2007-01

Locations

DE (1)