Actively Recruiting

Age: 18Years +
All Genders
ID01485575

Mechanical Properties of the Internal Limiting Membrane and Intraoperative Utility of Brilliant Blue G and Indocyanine Green Assisted Chromovitrectomy

Led by University Hospital, Basel, Switzerland · Updated on 2025-02-13

50

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University Hospital, Basel, Switzerland

Lead Sponsor

U

University of the Italian Switzerland

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research focuses on improving the surgical removal of the Internal Limiting Membrane (ILM), a thin layer in the retina vital for vision, especially in patients with macular edema. The study evaluates the properties and safety of different dyes used during eye surgery to make ILM removal safer and easier. The commonly used dye Indocyanine Green (ICG) stains well but may have toxic effects, while alternatives like Brilliant Blue G (BBG) are safer but less popular. Researchers aim to find or modify dyes for better staining and safer use during surgery. The study observes the use of vital dyes, including a new "Heavy BBG" (BBG with Deuterium Oxide) and the impact of intraoperative light filters like orange, green, and yellow filters during vitrectomy with xenon endoillumination. It examines how these dyes and filters affect the visibility and handling of the ILM. New dye preparations and protocols are tested to improve staining and grip without increasing toxicity. The study involves no additional patient treatment beyond standard surgery. Participants undergo vitrectomy using one of the three dyes (BBG, ICG, or Trypan Blue) combined with sequential use of light filters to determine the best contrast. Researchers analyze removed ILM tissue samples for thickness, stiffness, and surface features, as well as video recordings to assess dye contrast. No follow-up patient contact is required after surgery, and analyses may take up to a year. The study focuses on careful measurement of tissue properties and dye effects to guide safer and more effective surgical techniques.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Over 18 years of age
  • No chromovitrectomy surgery in the past 6 months
  • Only one of three vital dyes (Brilliant Blue G, Indocyanine Green, or Trypan Blue) used during surgery
Not Eligible

You will not qualify if you...

  • Chromovitrectomy surgery in the last 6 months
  • Pregnant patients
  • Patients under 18 years of age

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate post-operative period

Participants undergo vitrectomy surgery during which different intraoperative light filters are applied sequentially to assess their effect on the contrast behavior of vital dyes used for staining the internal limiting membrane (ILM).

1 surgery visit

Post-operative Follow-up

Duration - Follow-up duration as per routine clinical care

Participants are monitored after surgery to assess recovery and collect data related to surgical outcomes. No further patient contact is required after surgery for analysis of ILM properties and contrast assessments.

Follow-up visits as per routine care

Trial Site Locations

Total: 3 locations

1

General Hospital Linz

Linz, Austria, 4010

Actively Recruiting

2

St. Gallen Hospital

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

Actively Recruiting

3

Oftacentro

Paradiso, Canton Ticino, Switzerland, 6900

Actively Recruiting

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Research Team

P

Paul B. Henrich, MD, Ph.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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