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Recruiting NCT06771908

NCT06771908 THE ROLE OF HEXAMIDINE DIISETHIONATE (ZAMIDINE®) 1MG/ML 0.6ML EYE DROPS IN THE PROPHYLAXIS OF SURGERY OFTALMIC

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Clinical Trial Summary
NCT ID NCT06771908
Status Recruiting
Phase —
Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Condition Eye Disease
Study Type OBSERVATIONAL
Enrollment 56 participants
Start Date 2025-02-01
Primary Completion 2026-02-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 90 Years
Study Type OBSERVATIONAL
Interventions
Conjunctival Swab

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 56 participants in total. It began in 2025-02-01 with a primary completion date of 2026-02-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Data will be gathered from patients who report having any kind of recurrent conjunctivitis and who, in accordance with clinical practice, are scheduled to have intravitreal injections, glaucoma surgery, cataract surgery, vitrectomy, combined cataract and vitrectomy, or corneal transplantation. The data will be obtained using pseudonyms from the patients' medical records and will include the outcomes of swabs and surgeries performed in accordance with clinical practice for the patient's condition. The following swabs will be taken into consideration for data analysis: Four days before to surgery, a conjunctival swab is used to check for the presence and load of species that do not make up the typical conjunctival flora (Baseline-T0). On the day of operation, a conjunctival swab is taken before to entering the recovery room (T1). Following three minutes of 5% iodopovidone instillation in the eye to be operated on, a conjunctival swab (T2) was used. Additionally, we will gather follow-up data from the medical record 24 and 30 hours after surgery (at day 34 +/- 7 days).

Eligibility 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.

Contact & Investigator

Central Contact

Stanislao Rizzo, MD, Prof

✉ oculistica@policlinicogemelli.it

📞 0630151

Frequently Asked Questions

Who can join the NCT06771908 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Eye Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06771908 currently recruiting?

Yes, NCT06771908 is actively recruiting participants. Contact the research team at oculistica@policlinicogemelli.it for enrollment information.

Where is the NCT06771908 trial being conducted?

This trial is being conducted at Rome, Italy.

Who is sponsoring the NCT06771908 clinical trial?

NCT06771908 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 56 participants.

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