Efficacy and Safety Assessment of Azyter® (T1225) in Peri-Operative Antibio-Prophylaxis (ocular surface decontamination) for Cataract Surgery

Completed

• Conditions: Cataract surgery; Surgery; Other cataract

• Registration Number: ISRCTN41154297
• Lead Sponsor: aboratoires Thea (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-01
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Signed and dated informed consent
2. Male or female aged from 18 to 80 years old
3. Uncomplicated cataract
4. Scheduled to undergo cataract surgery (phacoemulsification ? foldable intra-ocular lens surgery with injector ? clear corneal incision)

Exclusion Criteria

Patients with the following ophthalmic conditions will be excluded:
1. Surgical conditions in the eye to be operated:
1.1. Combined surgery.
1.2. Other cataract aetiologies than senile or pre-senile cataract.
2. Non-surgical conditions in the eye to be operated:
2.1. Dacryocystitis and all others pathologies of tears drainage system.
2.2. Inflammatory ocular disease (uveitis, herpetic keratitis).
2.3. Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis).
2.4. History of ocular traumatism, infection or inflammation within the last 3 months.
3. Ophthalmic condition in the contra lateral eye:
3.1. Best corrected visual acuity < 1/10.
3.2. Patient already included in the study for phakoexeresis.
3.3. History of surgical complication (notably endophthalmitis)
4. Ophthalmic condition in either eye:
4.1. Presence of glaucoma and/or ocular hypertension history.
4.2. Presence of any other ocular pathology such as dry-eye syndrome, allergy in either eye likely to require a topical treatment from Day-15 to Day 5 conjunctival sampling.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of positive cultures on the day of surgery in the three study groups.

Secondary Outcome Measures

Name	Time	Method
1. Proportion of positive cultures at endpoint (day of surgery) depending on the sampling site.<br>2. Proportion of positive cultures at Day 5 after surgery.<br>3. Numeration of germ and of species, on Day -2, Day 0 and Day 5.