An observational study in Eye Disease and Conjunctivitis, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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).
To determine if Zamidine® reduces ocular surface bacterial flora in surgical prophylaxis.
Secondary goals. To quantify and qualitatively evaluate ocular surface bacterial flora,
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 before operation day's recovery room (T1).
Follow-up data at 24 and 30 days after surgery (day 34 +- 7 days) will be collected from the medical record.
85 studies on the registry are indexed under Conjunctivitis; 5 are open to participants now.
This study's planned enrollment of 56 is below the median of 254 across 18 observational studies indexed under Conjunctivitis.
Browse Conjunctivitis studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Compared within Conjunctivitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Eye Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with a history of recurrent conjunctivitis who are scheduled for minor or major ocular surgery.
Diagnostic Test: Conjunctival Swab
CFU/ml by bacterial species before and after prophylaxis.
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
Plan to share: No
Start is estimated for Feb 2025; primary completion for Feb 2026, 12 months later.
How these figures are worked out, and which studies are left out of them.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS →