RecruitingNCT06771908

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


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

56 participants

Start Date

Feb 1, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria4

  • Age 18 years or older, male and female;
  • 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®)
  • Positive history of recurrent conjunctivitis in the eye requiring surgery.
  • Written informed consent.

Exclusion Criteria2

  • Age < 18 years;
  • Refusal to give informed consent.

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Interventions

DIAGNOSTIC_TESTConjunctival Swab

CFU/ml by bacterial species before and after prophylaxis.


Locations(1)

Prof. Stanislao Rizzo

Rome, Italy

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NCT06771908


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