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Intraoperative Utility of Brilliant Blue g (Bbg) and Indocyanine Green (Icg) Assisted Chromovitrectomy

This study is currently recruiting participants.
Verified February 2013 by University Hospital, Basel, Switzerland
Sponsor:
Collaborators:
Clinical Trial Unit, University Hospital Basel, Switzerland
University of Pittsburgh
Ludwig-Maximilians - University of Munich
General Hospital Linz
Medical University of Graz
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01485575
First received: November 28, 2011
Last updated: February 18, 2013
Last verified: February 2013
History of Changes
  Purpose

Intravitreal dyes are intended to make the surgical extraction of the Internal limiting membrane (ILM) safer and more complete. However, the search for an adequate vitaly dye is ongoing. The most commonly used vital dye is Indocyanine green (ICG), although it is not approved for intravitreal use and has been associated with ocular toxicity. The reason for its continued popularity seems to be that it stains the ILM better than the approved and less toxic alternative substances Brilliant Blue G (BBG) and Trypan blue (TB). According to anecdotal reports from surgeons, another reason for ICGs popularity may be the fact that it seems to make ILM removal easier. Ultimately, the intention of the investigators research is to identify possible modifications to existing dyes to reach improved intraoperative dye utility combined with a favorable safety profile.


Condition Intervention
Macular Edema
 Procedure: Use of intraoperative filters in vitrectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intraoperative Utility of Brilliant Blue g (Bbg) and Indocyanine Green (Icg) Assisted Chromovitrectomy

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • ILM thickness, stiffness and roughness [ Time Frame: No further patient contact is requried after surgery. Analysis of the specimens may take up to one year ] [ Designated as safety issue: No ]
    Measurements under the Atomic force microscope will show wether the use of ICG or BBG influences material properties of the ILM (for example, an increased stiffness may explain a better "grip").


Secondary Outcome Measures:
  • Contrast between the stained ILM and the underlying tissue [ Time Frame: No further patient contact is requried after surgery. Analysis of the video frames may take up to one year ] [ Designated as safety issue: No ]
    Intraoperative videos will be analysed to understand under which circumstances vital dyes produce the best contrast visible to the human eye


Biospecimen Retention:   Samples Without DNA

Internal limiting membrane as removed during routine surgery.


Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Filter use during vitrectomy Procedure: Use of intraoperative filters in vitrectomy
During vitrectomy with xenon endoillumination, an orange, green and a yellow filter are applied sequentially to determine which one produces the best contrast behavior of vital dyes
Other Name: Stellaris PC surgical (Bausch&Lomb surgical,Aliso Viejo,CA)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive patients treated with Chromovitrectomy at 3 tertiary care hospitals.

Criteria

Inclusion Criteria:

  • Over 18 Years of age
  • No other chromovitrectomy in previous 6 months
  • Only one of three vitaly dyes used intraoperatively (BBG, ICG or TB)

Exclusion Criteria:

  • Previous chromovitrectomy during last 6 months
  • Pregnant patients
  • Patients under 18 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485575

Contacts
Contact: Paul B. Henrich, MD +41 61 265 2525 henrichp@uhbs.ch

Locations
Austria
General Hospital Linz Recruiting
Linz, Austria, 4010
Contact: Rupert W Strauss, MD     +43 732 7806 - 73425     rupert.strauss@akh.linz.at    
Switzerland
Universtiy of Basel Recruiting
Basel, BS, Switzerland, 4056
Contact: Paul B Henrich, MD     +41 265 2525     henrichp@uhbs.ch    
St. Gallen Hospital Recruiting
St. Gallen, SG, Switzerland, 9007
Contact: Christophe Valmaggia, MD     +41 71 494 11 11     Christophe.Valmaggia@kssg.ch    
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Clinical Trial Unit, University Hospital Basel, Switzerland
University of Pittsburgh
Ludwig-Maximilians - University of Munich
General Hospital Linz
Medical University of Graz
Investigators
Principal Investigator: Paul B Henrich, MD University of Basel, Department of Ophthalmology, Basel Switzerland
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01485575     History of Changes
Other Study ID Numbers: ILM-AMF2
Study First Received: November 28, 2011
Last Updated: February 18, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
Chromovitrectomy
Indocyanine green
ICG
Brilliant Blue G
BBG
 Trypan blue
TB
Internal limiting membrane
ILM

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013