Indocyanine Green or Trypan Blue for Delamination of the Internal Limiting Membrane in Macular Hole Surgery
Primary Purpose
Idiopathic Macular Hole
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Delamination of the Internal limiting membrane
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Macular Hole focused on measuring macular hole surgery, indocyanine green, trypan blue, internal limiting membrane
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Eye Clinic, University Schleswig-Holstein, Campus Lübeck
Outcomes
Primary Outcome Measures
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 Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00419185
Brief Title
Indocyanine Green or Trypan Blue for Delamination of the Internal Limiting Membrane in Macular Hole Surgery
Official Title
Internal Limiting Membrane (ILM)- Peeling With Indocyanine Green or Trypan Blue in Macular Hole Surgery: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Luebeck
4. Oversight
5. Study Description
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.
Detailed Description
In several clinical trials the positive effect of inner limiting membrane peeling (ILM) on anatomical and functional outcome in macular hole surgery has been reported. Controversies, however, exist regarding the application and possible toxicity of dyes, facilitating the surgical procedure. Since dyes were introduced for ILM peeling several authors reported on the use of indocyanine green and trypan blue (TB) for membrane peeling or ILM removal. Recent experimental and clinical reports raise concern about the safety of ICG-assisted membrane peeling. Morphological and functional damage was described in an animal model, in human donor eyes, in cultured human pigment epithelial cells and in clinical studies using ICG in macular surgery. The intraocular tolerance of TB has been demonstrated in rabbit eyes and in retinal pigment epithelium cell viability studies. Higher concentrations of TB (0.6 or 4 mg/ml) lead to toxicity on cultured RPE cells, but the application of lower clinically relevant levels did not show any significant effect. A recent retrospective comparative analysis indicates that TB may be the safer dye. They found better anatomical and functional results than with the use of ICG.
Therefore, the aim of this study was to compare the anatomical and functional outcome after dye-assisted peeling of the ILM in patients with idiopathic macular holes using ICG or TB in a prospective and randomized trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Macular Hole
Keywords
macular hole surgery, indocyanine green, trypan blue, internal limiting membrane
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Delamination of the Internal limiting membrane
Primary Outcome Measure Information:
Title
Primary outcome was ETDRS visual acuity (VA: snellen equivalent) at two meters 3 months after surgery.
Title
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 Outcome Measure Information:
Title
Secondary outcome measures were successful hole closure defined only as complete closure of the inner retinal dehiscence determined by OCT,
Title
cystoid macular edema as revealed by fluorescein angiography (FLA) and
Title
postoperative scotoma shown by SLO-microperimetry.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans M Hoerauf, Prof.
Organizational Affiliation
Eye Clinic, University Schleswig Holstein, Campus Lübeck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Clinic, University Schleswig-Holstein, Campus Lübeck
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
10922208
Citation
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.
Results Reference
background
PubMed Identifier
11013203
Citation
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.
Results Reference
background
PubMed Identifier
12429240
Citation
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.
Results Reference
background
PubMed Identifier
11772571
Citation
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.
Results Reference
background
PubMed Identifier
11054324
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. doi: 10.1016/s0161-6420(00)00375-4.
Results Reference
background
PubMed Identifier
12543755
Citation
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.
Results Reference
background
PubMed Identifier
11935278
Citation
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.
Results Reference
background
PubMed Identifier
12506091
Citation
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.
Results Reference
background
PubMed Identifier
11530072
Citation
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.
Results Reference
background
PubMed Identifier
12140045
Citation
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.
Results Reference
background
PubMed Identifier
11755843
Citation
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.
Results Reference
background
PubMed Identifier
12736727
Citation
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.
Results Reference
background
PubMed Identifier
15592868
Citation
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.
Results Reference
background
PubMed Identifier
12920526
Citation
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.
Results Reference
background
PubMed Identifier
15548818
Citation
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.
Results Reference
background
PubMed Identifier
15774917
Citation
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.
Results Reference
background
PubMed Identifier
15249363
Citation
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.
Results Reference
background
PubMed Identifier
11425673
Citation
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.
Results Reference
background
PubMed Identifier
14641152
Citation
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.
Results Reference
background
PubMed Identifier
15059697
Citation
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.
Results Reference
background
PubMed Identifier
14752502
Citation
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.
Results Reference
background
PubMed Identifier
15069433
Citation
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.
Results Reference
background
PubMed Identifier
11530049
Citation
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.
Results Reference
background
PubMed Identifier
12617707
Citation
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.
Results Reference
background
PubMed Identifier
16226539
Citation
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.
Results Reference
background
PubMed Identifier
12766079
Citation
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.
Results Reference
background
PubMed Identifier
15364242
Citation
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.
Results Reference
background
PubMed Identifier
15277504
Citation
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.
Results Reference
background
PubMed Identifier
15234283
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. doi: 10.1016/j.ajo.2004.02.061.
Results Reference
background
PubMed Identifier
12888042
Citation
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.
Results Reference
background
PubMed Identifier
17353402
Citation
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.
Results Reference
derived
Learn more about this trial
Indocyanine Green or Trypan Blue for Delamination of the Internal Limiting Membrane in Macular Hole Surgery
We'll reach out to this number within 24 hrs