Actively Recruiting

Age: 18Years - 90Years
All Genders
ID06771908

Role of Hexamidine Diisethionate (Zamidine) 1mg/ml Eye Drops in Preventing Bacterial Flora Changes During Eye Surgery in Patients with Recurrent Conjunctivitis

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-01-13

56

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates the use of Hexamidine Diisethionate (Zamidine®) eye drops to reduce bacterial presence on the eye surface before ophthalmic surgeries. The study focuses on patients with any type of recurrent conjunctivitis who are scheduled for procedures such as intravitreal injections, glaucoma surgery, cataract surgery, vitrectomy, combined cataract and vitrectomy, or corneal transplantation. The goal is to evaluate bacterial changes related to surgical prophylaxis and to monitor for post-surgery infections like endophthalmitis. Participants will have conjunctival swabs taken at multiple times: four days before surgery to detect unusual bacteria, on the surgery day before entering the recovery room, and after three minutes of applying 5% iodopovidone to the operative eye. These samples will be analyzed to measure and compare bacterial load around the time of surgery. The study collects data from medical records in a pseudonymized manner and follows standard clinical practices for the patients' conditions. During the study, follow-up information will be gathered from medical records 24 and 30 days after surgery. Researchers will assess bacterial species and quantities before and after prophylaxis, as well as monitor surgical outcomes and any adverse events. This comprehensive data collection helps understand the role of Zamidine® in surgical antisepsis and infection prevention over a period extending slightly beyond a month after surgery.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, male and female
  • Scheduled for ophthalmic surgery requiring antiseptic prophylaxis such as Zamidine®
  • History of recurrent conjunctivitis in the eye to be operated on
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Younger than 18 years old
  • Declined to give informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Prof. Stanislao Rizzo

Rome, Italy, 00168

Actively Recruiting

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Research Team

S

Stanislao Rizzo, MD, Prof

V

Valentina Cestrone, Dr

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Comparison of the Effects of Povidone-Iodine 5%, Polyhexamethylene Biguanide, and Chlorhexidine as a Preoperative Antiseptic in Endophthalmitis Prophylaxis in Patients Undergoing Phacoemulsification Cataract Surgery.

Alireza Peyman, Mehran Hosseini, Tahmineh Narimani

https://pubmed.ncbi.nlm.nih.gov/32775308

The ocular microbiome and microbiota and their effects on ocular surface pathophysiology and disorders.

Pasquale Aragona, Christophe Baudouin, Jose M Benitez Del Castillo...

https://pubmed.ncbi.nlm.nih.gov/33819460