Mechanical Properties of the Internal Limiting Membrane and Intraoperative Utility of Brilliant Blue g (Bbg) and Indocyanine Green (Icg) Assisted Chromovitrectomy

NCT01485575 | Recruiting

• 1 other identifier: ILM-AMF2
• Study Type: observational
• Target: 50
• Locations: 2 countries
• Sites: 3

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.

Conditions

Macular Edema

Keywords

Chromovitrectomy; Indocyanine green; ICG; Brilliant Blue G; BBG; Trypan blue; TB; Internal limiting membrane; ILM

Outcome Measures

Primary Outcomes (1)

• ILM thickness, stiffness and roughness

  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").

  No further patient contact is required after surgery. Analysis of the specimens may take up to one year

Secondary Outcomes (1)

• Contrast between the stained ILM and the underlying tissue

  No further patient contact is required after surgery. Analysis of the video frames may take up to one year

Study Arms (1)

Filter use during vitrectomy

Procedure: Use of intraoperative filters in vitrectomy

Interventions

Use of intraoperative filters in vitrectomy PROCEDURE

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

Also known as: Stellaris PC surgical (Bausch&Lomb surgical,Aliso Viejo,CA)

Filter use during vitrectomy

Eligibility Criteria

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

Study Population

Consecutive patients treated with Chromovitrectomy at 3 tertiary care hospitals.

You may qualify if:

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

You may not qualify if:

• Previous chromovitrectomy during last 6 months
• Pregnant patients
• Patients under 18 years of age

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University of the Italian Switzerland: collaborator
• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator
• General Hospital Linz: collaborator
• Oftacentro SA: collaborator

Study Sites (3)

General Hospital Linz

Linz, 4010, Austria

RECRUITING

St. Gallen Hospital

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

RECRUITING

Oftacentro

Paradiso, Canton Ticino, 6900, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Internal limiting membrane as removed during routine surgery.

MeSH Terms

Conditions

Macular Edema

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Paul B Henrich, MD

  Oftacentro, Lugano-Paradiso, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul B. Henrich, MD, Ph.D.

CONTACT

+41 91 9932727; henrich.oftacentro@hin.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: December 5, 2011
• Study Start: November 1, 2011
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

AU (1); CH (2)