Mechanical Properties of the Internal Limiting Membrane and Intraoperative Utility of Brilliant Blue g (Bbg) and Indocyanine Green (Icg) Assisted Chromovitrectomy
Recruiting now
Conditions studied: Macular Edema
In brief
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.
Key facts
- Study ID
- NCT01485575
- Run by
- University Hospital, Basel, Switzerland
- People needed
- 50
- Starts
- 2011-11-01
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2025-02-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- General Hospital Linz — Linz, Austria (enrolling)
- St. Gallen Hospital — Sankt Gallen, Canton of St. Gallen, Switzerland (enrolling)
- Oftacentro — Paradiso, Canton Ticino, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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