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Idiopathic Macular HoleNCT00419185

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

A study testing Delamination of the Internal limiting membrane in people with Idiopathic Macular Hole, run by University of Luebeck at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Idiopathic Macular Hole
What is being tested?
Delamination of the Internal limiting membrane
Type of treatment
Surgery or procedure
How many people
40 participants
Where
1 siteGermany
Study dates
Apr 2003to Jan 2005
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Eye Clinic, University Schleswig-Holstein, Campus Lübeck

    Lübeck, Schleswig-Holstein, 23538

Other trials in Germany

About this study

Official title: Internal Limiting Membrane (ILM)- Peeling With Indocyanine Green or Trypan Blue in Macular Hole Surgery: A Prospective Randomized Trial

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.

Read the 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.

Being tested
Delamination of the Internal limiting membrane
Keywords
macular hole surgery, indocyanine green, trypan blue, internal limiting membrane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Delamination of the Internal limiting membraneProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

  2. 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)

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

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

  3. postoperative scotoma shown by SLO-microperimetry.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2007 (estimated)
  2. Study startApr 2003
  3. Study completionJan 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
40 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00419185
Sponsor's protocol ID
UKSH
Status last verified
Jan 2007
First submitted
5 Jan 2007
Last updated
8 Jan 2007
Results posted
No

Publications

  • 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.

    PubMed 10922208

  • 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.

    PubMed 11013203

  • 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.

    PubMed 12429240

  • 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.

    PubMed 11772571

  • 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.

    PubMed 11054324

  • 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.

    PubMed 12543755

  • 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.

    PubMed 11935278

  • 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.

    PubMed 12506091

  • 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.

    PubMed 11530072

  • 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.

    PubMed 12140045

  • 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.

    PubMed 11755843

  • 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.

    PubMed 12736727

  • 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.

    PubMed 15592868

  • 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.

    PubMed 12920526

  • 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.

    PubMed 15548818

Questions about this trial

What is this clinical trial studying?

A study testing Delamination of the Internal limiting membrane in people with Idiopathic Macular Hole, run by University of Luebeck at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary outcome was ETDRS visual acuity (VA: snellen equivalent) at two meters 3 months after surgery.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00419185, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2007.

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