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

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 design

Treatments tested in this trial

  • Use of intraoperative filters in vitrectomy

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

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