Effectiveness of Liposomial Ozonized-Oil for Cataract Surgery

• Status: Completed
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of the antimicrobial efficacy of a liposomal ozone-based solution (OZODROP®) , vs placebo in 200 patients undergoing cataract surgery by phacoemulsification .

The clinical trial will last 3 days of treatment per patient. The conjunctival swab will be taken for each of the two eyes (in treatment and control) at T0 (before starting the treatment - 3 days before the cataract surgery) and at T3 (after 3 days of treatment - immediately before the cataract surgery). The last OZODROP instillation will take place 10 minutes before taking the sample.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Molise
• Collaborators: A.O.U. Città della Salute e della Scienza - Molinette Hospital; Azienda Ospedaliera Fatebenefratelli e Oftalmico; Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi; Azienda Ospedaliera Universitaria Mater Domini, Catanzaro; Azienda Ospedaliero-Universitaria Careggi; Azienda Ospedaliero-Universitaria Consorziale, Bari; Azienda Ospedaliero, Universitaria Pisana; Azienda Policlinico Umberto I; Azienda Policlinico Umberto I, Roma; Casa di cura GEPOS, Telese; Centro Medico Oculistico ALSO, Saronno; Centro oftalmologico LASERVISTA, Caserta; Clinica Mediterranea; Clinica Mediterranea, Napoli; Fondazione G.B. Bietti, IRCCS , Roma; Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; Ospedale Borgo Trento - Verona; Ospedale G. Panico, Tricase; Ospedale generale regionale F. Miulli, Acquaviva delle Fonti; Ospedale Oftalmico, Torino; Ospedale Policlinico Casilino, Roma; Ospedale Policlinico San Martino; Ospedale San Carlo di Nancy, Roma; Ospedale Santa Croce-Carle Cuneo; Policlinico San Matteo Pavia Fondazione IRCCS; S.Eugenio Hospital; Studio oculistico Franchini; Studio oculistico Laborante; U.C.O Ospedali Civico di Cristina Benfratelli; Università degli Studi del Molise, Clinica Oculistica; University of Chieti

Criteria

Inclusion Criteria:

1. Age over 18 years

2. Patients eligible for cataract surgery

3. Willingness to participate in the study following the indications

Exclusion Criteria:

1. Use of topical and / or systemic antibiotics and other topical antiseptics during the study

2. Presence of topical ocular therapies that cannot be suspended for the entire duration of the study

3. Ongoing ocular or systemic inflammatory or infectious processes

4. Hypersensitivity to the constituents of the preparation in study