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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2026-02-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Eye Disease Conjunctivitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients who need ophthalmic surgery

Patients with a history of recurrent conjunctivitis who are scheduled for minor or major ocular surgery.

Conjunctival Swab

Intervention Type DIAGNOSTIC_TEST

CFU/ml by bacterial species before and after prophylaxis.

Interventions

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Conjunctival Swab

CFU/ml by bacterial species before and after prophylaxis.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.