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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Age < 18 years;

Refusal to give informed consent.

Trial population

Saranno inclusi nello studio i pazienti che devono eseguire qualsiasi intervento di chirurgia oftalmica minore o maggiore con anamnesi positiva di congiuntiviti ricorrenti, secondo pratica clinica e che necessitano di profilassi chirurgica antisettica.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Conjunctival Swab

    Diagnostic test

    CFU/ml by bacterial species before and after prophylaxis.

Treatment groups

56 Participants
are divided into 1 treatment group
Group A: Patients who need ophthalmic surgery1 intervention

Trial outcomes

Primary outcomes

1

Bacterial species before and after prophylaxis.

CFU/ml by bacterial species before and after prophylaxis.

Time frame
4 days before prophylaxis, the day of surgery before and after povidone-iodine

Secondary outcomes

Other outcomes

Sponsors and contacts

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