Efficacy and safety assessment of intracameral T2380 (Fixed combination of lidocaïne, phenylephrine and tropicamide) to obtain mydriasis in patients with small pupils for cataract surgery by phacoemulsificatio

• Conditions: The primary aim of this study is to evaluate mydriasis obtained with T2380 (Fixed combination of lidocaïne, phenylephrine and tropicamide) in patients with small pupils; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2012-005576-33-FR
• Lead Sponsor: aboratoires Théa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-10
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Signed and dated informed consent
•Male or female aged over 40 years old of age
•Scheduled to undergo cataract surgery by phacoemulsification (Under topical anesthesia and through clear corneal incision with placement in the bag of an foldable IOL)
•Dilatation of the pupil from 5mm = Pupil diameter < 7mm after the following dilatation protocol at the selection visit: 3 combined instillations of TROPICAMIDE 0.5%® + NEOSYNEPHRINE 10%® at 10 minutes intervals

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Ophthalmic exclusion criteria

•Surgical conditions in the eye to be operated:
-Combined surgery
-Previous intraocular surgery
•Non-surgical conditions in the eye to be operated:
-Iatrogenic or traumatic or congenital cataract.
-Deformed pupil and /or iris synechiae
-Very dark iris impeding slit lamp or video measures of pupil dilatation
-Eye movement disorder (Nystagmus,..)
-Dacryocystitis and all others pathologies of tears drainage system
-History of Inflammatory ocular disease (uveitis, herpetic keratitis,…)
-Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis)
-History of ocular traumatism, infection or inflammation within the last 3 months
•Ophthalmic conditions in the contra lateral eye:
-Best corrected visual acuity < 1/10
-Patient already included in the study for phakoexeresis
-History of ophthalmic surgical complication

Other exclusion criteria are defined in this protocol (Systemic/non ophthalmic exclusion criteria, Specific exclusion criteria for women, Exclusion criteria related to general conditions, Exclusion criteria related to concomitant medications).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified