Evaluating dyes for safer eye surgery
Mechanical Properties of the Internal Limiting Membrane and Intraoperative Utility of Brilliant Blue g (Bbg) and Indocyanine Green (Icg) Assisted Chromovitrectomy
This study is testing two dyes used during eye surgery to see if they can make the procedure safer and more effective for patients with conditions like macular edema.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 3 sites (Linz and 2 other locations) |
| Trial ID | NCT01485575 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the mechanical properties of the internal limiting membrane (ILM) and the effectiveness of intraoperative dyes, specifically Brilliant Blue G (BBG) and Indocyanine Green (ICG), during chromovitrectomy procedures. The research aims to enhance the safety and efficacy of ILM removal, which is crucial for treating conditions like macular edema. By analyzing the performance of these dyes, the study seeks to identify modifications that could improve their utility while minimizing ocular toxicity. The study involves patients undergoing vitrectomy and utilizes data from deceased donor membranes for additional insights.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have not undergone chromovitrectomy in the past six months.
Not a fit: Patients who have had a chromovitrectomy in the last six months or are under 18 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective surgical techniques for patients with macular edema.
How similar studies have performed: Other studies have explored the use of intraoperative dyes in vitrectomy, but the specific combination and modifications being tested in this study are novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over 18 Years of age * No other chromovitrectomy in previous 6 months * Only one of three vitaly dyes used intraoperatively (BBG, ICG or TB) Exclusion Criteria: * Previous chromovitrectomy during last 6 months * Pregnant patients * Patients under 18 years of age
Where this trial is running
Linz and 2 other locations
- General Hospital Linz — Linz, Austria (Recruiting)
- St. Gallen Hospital — Sankt Gallen, Canton of St. Gallen, Switzerland (Recruiting)
- Oftacentro — Paradiso, Canton Ticino, Switzerland (Recruiting)
Study contacts
- Principal investigator: Paul B Henrich, MD — Oftacentro, Lugano-Paradiso, Switzerland
- Study coordinator: Paul B. Henrich, MD, Ph.D.
- Email: henrich.oftacentro@hin.ch
- Phone: +41 91 9932727
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.