Health TrialsbyHealthPanel

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

ConditionMacular Edema
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Over 18 Years of age

No other chromovitrectomy in previous 6 months

Only one of three vitaly dyes used intraoperatively (BBG, ICG or TB)

Disqualifiers

Previous chromovitrectomy during last 6 months

Pregnant patients

Patients under 18 years of age

Trial population

Consecutive patients treated with Chromovitrectomy at 3 tertiary care hospitals.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Use of intraoperative filters in vitrectomy

    Procedure/Surgery

    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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Filter use during vitrectomy1 intervention

Trial outcomes

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").

Time frame
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

Intraoperative videos will be analysed to understand under which circumstances vital dyes produce the best contrast visible to the human eye

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Basel, Switzerland

Lead sponsor

University of the Italian Switzerland

Collaborator

Clinical Trial Unit, University Hospital Basel, Switzerland

Collaborator

General Hospital Linz

Collaborator

Oftacentro SA

Collaborator

Source ClinicalTrials.gov
Apply now