Using Zamidine eye drops to prevent infections during eye surgery
Official title: THE ROLE OF HEXAMIDINE DIISETHIONATE (ZAMIDINE®) 1MG/ML 0.6ML EYE DROPS IN THE PROPHYLAXIS OF SURGERY OFTALMIC
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06771908 · Data updated 2026-11-12
This study is testing if Zamidine eye drops can help prevent infections in patients having eye surgery by reducing harmful bacteria on the eye's surface.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 56 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Status | Recruiting |
| Started | February 1, 2025 |
| Main results expected | February 1, 2026 |
| Study ends | February 1, 2026 |
| Registry record updated | January 13, 2025 |
| Trial ID | NCT06771908 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a history of recurrent conjunctivitis who require ophthalmic surgery.
✕Probably not a fit
Patients under 18 years of age or those who refuse to provide informed consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the effectiveness of Zamidine® eye drops in reducing ocular surface bacterial flora in patients scheduled for various ophthalmic surgeries, including cataract surgery and vitrectomy. Data will be collected from patients with a history of recurrent conjunctivitis, focusing on swabs taken before and after surgery to assess bacterial load. The study will analyze the incidence of endophthalmitis and compare the results with standard antiseptic procedures using iodopovidone. Patient medical records will be pseudonymized to ensure confidentiality while gathering relevant data.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of postoperative infections in patients undergoing eye surgery.
How similar studies have gone: While similar studies have explored antiseptic prophylaxis in ophthalmic surgery, the specific use of Zamidine® in this context is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years or older, male and female; 2. Patient requiring ophthalmic surgery (intravitreal injections, glaucoma surgery, cataract surgery, vitrectomy, combined cataract and vitrectomy, corneal transplantation) and in need of antiseptic surgical prophylaxis (e.g., Zamidine®) 3. Positive history of recurrent conjunctivitis in the eye requiring surgery. 4. Written informed consent. Exclusion Criteria: 1. Age \< 18 years; 2. Refusal to give informed consent.
Where it's running
-
Prof. Stanislao Rizzo
Rome, Italy Recruiting
Study contacts
- Study coordinator: Stanislao Rizzo, MD, Prof
- Email: oculistica@policlinicogemelli.it
- Phone: 0630151
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.