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RecruitingNCT06771908ZAMI-PROUpdated Jan 13, 2025

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

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
56
Ages
18 Years to 90 Years
Sex
All
01

Study 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).

Read the detailed description

To determine if Zamidine® reduces ocular surface bacterial flora in surgical prophylaxis.

Secondary goals. To quantify and qualitatively evaluate ocular surface bacterial flora,

  • Compare bacterial load before and after surgery with 5% iodopovidone.
  • Determine sample endophthalmitis incidence. The study will include patients who are scheduled for intravitreal injections, glaucoma surgery, cataract surgery, vitrectomy, combined cataract and vitrectomy, corneal transplantation, and any type of recurrent conjunctivitis.

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 four days before surgery to detect and quantify non-native organisms.

A conjunctival swab before operation day's recovery room (T1).

  • a conjunctival swab (T2) after 3 minutes of 5% iodopovidone in the operative eye.

Follow-up data at 24 and 30 days after surgery (day 34 +- 7 days) will be collected from the medical record.

02

Conditions studied

  • Eye Disease
  • Conjunctivitis

Keywords

  • Ophthalmic prophylaxis
  • Surgery
  • Ophthalmic Swab
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Sampling method
Probability sample

Study 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.

Inclusion criteria

  1. Age 18 years or older, male and female;
  2. 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®)
  3. Positive history of recurrent conjunctivitis in the eye requiring surgery.
  4. Written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Age \< 18 years;
  2. Refusal to give informed consent.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
56 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients who need ophthalmic surgery

    Patients with a history of recurrent conjunctivitis who are scheduled for minor or major ocular surgery.

    Diagnostic Test: Conjunctival Swab

Interventions

  • Diagnostic testConjunctival Swab

    CFU/ml by bacterial species before and after prophylaxis.

05

What researchers measure

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

06

Study locations

1 of 1 sites recruiting
  • Prof. Stanislao Rizzo
    Rome, 00168, Italy
    • Stanislao Rizzo, MD,PhD · Contact
    Recruiting
07

References and documents

Publications

  • Merani R, Hunyor AP. Endophthalmitis following intravitreal anti-vascular endothelial growth factor (VEGF) injection: a comprehensive review. Int J Retina Vitreous. 2015 Jul 21;1:9. doi: 10.1186/s40942-015-0010-y. eCollection 2015. PubMed 27847602 ↗
  • Speaker MG, Milch FA, Shah MK, Eisner W, Kreiswirth BN. Role of external bacterial flora in the pathogenesis of acute postoperative endophthalmitis. Ophthalmology. 1991 May;98(5):639-49; discussion 650. doi: 10.1016/s0161-6420(91)32239-5. PubMed 2062496 ↗
  • Peyman A, Hosseini M, Narimani T. 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. Adv Biomed Res. 2020 Apr 22;9:15. doi: 10.4103/abr.abr_155_19. eCollection 2020. PubMed 32775308 ↗
  • Aragona P, Baudouin C, Benitez Del Castillo JM, Messmer E, Barabino S, Merayo-Lloves J, Brignole-Baudouin F, Inferrera L, Rolando M, Mencucci R, Rescigno M, Bonini S, Labetoulle M. The ocular microbiome and microbiota and their effects on ocular surface pathophysiology and disorders. Surv Ophthalmol. 2021 Nov-Dec;66(6):907-925. doi: 10.1016/j.survophthal.2021.03.010. Epub 2021 Apr 2. PubMed 33819460 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06771908
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
RIZZO STANISLAO (Director, Prof, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Jan 13, 2025
Start date
Feb 1, 2025 (estimated)
Primary completion
Feb 1, 2026 (estimated)
Completion
Feb 1, 2026 (estimated)
Last update
Jan 13, 2025

Study contacts

Stanislao Rizzo, MD, Prof
Contact
oculistica@policlinicogemelli.it
0630151
Valentina Cestrone, Dr
Contact
valentina.cestrone@guest.policlinicogemelli.it
0630154528

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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