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

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ClinicalTrials.gov Identifier: NCT01485575
Recruitment Status : Recruiting
First Posted : December 5, 2011
Last Update Posted : April 30, 2018
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

Brief Summary:

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.

Protocol was amended and approved concerning additional use of basal membrane of deceased donors.


Condition or disease Intervention/treatment
Macular Edema Procedure: Use of intraoperative filters in vitrectomy

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intraoperative Utility of Brilliant Blue g (Bbg) and Indocyanine Green (Icg) Assisted Chromovitrectomy
Study Start Date : November 2011
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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)



Primary Outcome Measures :
  1. ILM thickness, stiffness and roughness [ Time Frame: No further patient contact is required after surgery. Analysis of the specimens may take up to one year ]
    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 :
  1. Contrast between the stained ILM and the underlying tissue [ Time Frame: No further patient contact is required after surgery. Analysis of the video frames may take up to one year ]
    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.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485575


Contacts
Contact: Paul B. Henrich, MD +41 52 266 28 95 bernhard.henrich@ksw.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
St. Gallen Hospital Recruiting
St. Gallen, SG, Switzerland, 9007
Contact: Christophe Valmaggia, MD    +41 71 494 11 11    Christophe.Valmaggia@kssg.ch   
Kantonsspital Winterthur, Eye Clinic Recruiting
Winterthur, Switzerland, 8401
Contact: Paul B Henrich, MD    +41 52 266 28 95    bernhard.henrich@ksw.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 Kantonsspital Winterthur, Winterthur, Switzerland

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01485575     History of Changes
Other Study ID Numbers: ILM-AMF2
First Posted: December 5, 2011    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases