Conditions: Cataract
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 609
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the efficacy and safety assessment of T2380 for mydriasis and anaesthesia in phacoemulsification cataract surgery versus reference group (topical mydriatics and anaesthetic) 2X246 patients.

Detailed description:
In order to perform pupil size measurements and ocular discomfort assessments at specific times, the surgical procedure was divided into 5 time periods according to the following time points: T1 (just before first incision), T2 (just before viscoelastic injection), T3 (just before capsulorhexis), T4 (just before intraocular lens injection), and T5 (just before cefuroxime injection).

Arms:
arm 1: Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery.

At the beginning of surgery, 200 μL of T2380 were administrated intracamerally. arm 2: Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery.

Topical Mydriatic treatments were instilled three times before surgery.

Interventions: intervention 1: T2380 intervention 2: Mydriatics intervention 3: Tetracaine
Intervention descriptions: intervention 1: 200 microlitres of T2380 will be administrated intracamerally intervention 2: 3 drops of tropicamide and phenylephrine were instilled 30 minutes before surgery. The second and the third instillation of both phenylephrine and tropicamide will be realised respectively within 20 and 10 minutes before surgery. intervention 3: Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery

Protocol document: