Using Zamidine eye drops to prevent infections during eye surgery
THE ROLE OF HEXAMIDINE DIISETHIONATE (ZAMIDINE®) 1MG/ML 0.6ML EYE DROPS IN THE PROPHYLAXIS OF SURGERY OFTALMIC
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 |
|---|---|
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06771908 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of recurrent conjunctivitis who require ophthalmic surgery.
Not a fit: Patients under 18 years of age or those who refuse to provide informed consent will not benefit from this study.
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 performed: While similar studies have explored antiseptic prophylaxis in ophthalmic surgery, the specific use of Zamidine® in this context is novel.
Eligibility criteria
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 this trial is running
Rome
- Prof. Stanislao Rizzo — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Stanislao Rizzo, MD, Prof
- Email: oculistica@policlinicogemelli.it
- Phone: 0630151
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.