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

NCT06771908 | Recruiting DMC

• 1 other identifier: 7172
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Eye Disease; Conjunctivitis

Keywords

Ophthalmic prophylaxis; Surgery; Ophthalmic Swab

Outcome Measures

Primary Outcomes (1)

• Bacterial species before and after prophylaxis.

  CFU/ml by bacterial species before and after prophylaxis.

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

Study Arms (1)

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

Conjunctival Swab DIAGNOSTIC_TEST

CFU/ml by bacterial species before and after prophylaxis.

Patients who need ophthalmic surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Age \< 18 years;
• Refusal to give informed consent.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Prof. Stanislao Rizzo

Rome, 00168, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 27847602 BACKGROUND

• 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.

  PMID: 2062496 BACKGROUND

• 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.

  PMID: 32775308 BACKGROUND

• 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.

  PMID: 33819460 BACKGROUND

MeSH Terms

Conditions

Eye Diseases; Conjunctivitis

Condition Hierarchy (Ancestors)

Conjunctival Diseases

Central Study Contacts

Stanislao Rizzo, MD, Prof

CONTACT

0630151; oculistica@policlinicogemelli.it

Valentina Cestrone, Dr

CONTACT

0630154528; valentina.cestrone@guest.policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Prof

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)