Actively Recruiting

Age: 18Years - 90Years
All Genders
ID06771908

The Role of Hexamidine Diisethionate (Zamidineae) 1mg/ml Eye Drops in Preventing Infection During Eye Surgery

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

56

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Researchers are studying patients with recurrent conjunctivitis who are scheduled for various eye surgeries, such as intravitreal injections, glaucoma surgery, cataract surgery, vitrectomy, combined cataract and vitrectomy, or corneal transplantation. The trial aims to evaluate whether using Zamidineae eye drops can reduce the bacterial flora on the eye surface before surgery. This observational study will collect data from medical records while following routine clinical practices for these eye conditions. Participants will have conjunctival swabs taken at several time points: four days before surgery to check for unusual bacteria, on the day of surgery before entering the recovery room, and after three minutes of applying 5% iodopovidone to the eye. Data on bacterial species and load will be analyzed before and after surgery. Follow-up information will be gathered from medical records 24 and 30 days after surgery to assess outcomes. During the study, researchers will collect data using pseudonyms to protect patient identity. They will monitor bacterial species present on the eye surface before and after antiseptic treatment and surgery. The primary measurement is the bacterial species found at these different times. The total study participation spans from before surgery through about one month of follow-up after the procedure, with no additional interventions beyond standard care and swab collections.

CONDITIONS

Brief 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
  • Patient scheduled for ophthalmic surgery such as intravitreal injections, glaucoma surgery, cataract surgery, vitrectomy, combined cataract and vitrectomy, or corneal transplantation
  • History of recurrent conjunctivitis in the eye needing surgery
  • Written informed consent provided
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Refusal to provide informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - From 4 days before surgery to the day of surgery

Participants undergo conjunctival swabs to detect and quantify bacterial species before and after prophylaxis around the time of surgery.

3 visits (4 days before surgery, before surgery, after povidone-iodine on surgery day)

Long-term Monitoring

Duration - Approximately 1 month after surgery

Participants are monitored through medical record data collected 24 and 30 days after surgery to observe outcomes and infection incidence.

Data collected from medical records at 2 timepoints

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