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

Recruiting

• Conditions: Eye Disease; Conjunctivitis

• Registration Number: NCT06771908
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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).

Detailed Description

To determine if Zamidine® reduces ocular surface bacterial flora in surgical prophylaxis.

Secondary goals. To quantify and qualitatively evaluate ocular surface bacterial flora,

* Compare bacterial load before and after surgery with 5% iodopovidone.

* Determine sample endophthalmitis incidence. The study will include patients who are scheduled for intravitreal injections, glaucoma surgery, cataract surgery, vitrectomy, combined cataract and vitrectomy, corneal transplantation, and any type of recurrent conjunctivitis.

Data from patients' medical records will be pseudonymized and contain swabs and operation findings according to clinical practice for their condition.

Following swabs will be analyzed for data:

- a conjunctival swab four days before surgery to detect and quantify non-native organisms.

A conjunctival swab before operation day's recovery room (T1).

- a conjunctival swab (T2) after 3 minutes of 5% iodopovidone in the operative eye.

Follow-up data at 24 and 30 days after surgery (day 34 +- 7 days) will be collected from the medical record.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Study Start: 2025-02-01
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bacterial species before and after prophylaxis.	4 days before prophylaxis, the day of surgery before and after povidone-iodine	CFU/ml by bacterial species before and after prophylaxis.

Trial Locations

Locations (1)

Prof. Stanislao Rizzo; 🇮🇹 Rome, Italy