Efficacy and safety assessment of intracameral T2380 (Fixed combination of lidocaïne, phenylephrine and tropicamide) for anaesthesia and mydriasis in phacoemulsification cataract surgery

• Conditions: The aim of the development was to develop a combination of active substances enabling to obtain at the same time a mydriasis and an anaesthesia during cataract surgery.; MedDRA version: 9.1Level: LLTClassification code 10002325Term: Anesthesia local; MedDRA version: 9.1Level: PTClassification code 10011719Term: Cycloplegia; MedDRA version: 9.1Level: LLTClassification code 10028521Term: Mydriasis

• Registration Number: EUCTR2008-003279-28-FR
• Lead Sponsor: aboratoires Théa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

[1.1]Signed and dated informed consent
[1.2]Male or female aged from 18 to 85 years old
[1.3]Senile or pre-senile cataract
[1.4]Scheduled to undergo cataract surgery (clear corneal self sealing incisions- phacoemulsification – foldable intra-ocular lens surgery with injector)
[1.5]Endothelial cell count > 2000 cell/mm2
[1.6]Pupil diameter = 7 mm

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Ophthalmic non-inclusion criteria (in either eye) [2.1]
[2.1.1]Surgical conditions in the eye to be operated:
[2.1.1.1]Combined surgery
[2.1.1.2] Previous intraocular surgery
[2.1.2]Non-surgical conditions in the eye to be operated:
[2.1.2.1]Pupillary abnormalities (irregular,..)
[2.1.2.2]Very dark iris
[2.1.2.3]Iris synechiae
[2.1.2.4]Eye movement disorder (Nystagmus,..)
[2.1.2.5]Dacryocystitis and all others pathologies of tears drainage system
[2.1.2.6]History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis)
[2.1.2.7]Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis)
[2.1.2.8]History of ocular traumatism, infection or inflammation within the last 3 months
[2.1.2.9]Pseudoexfoliation, exfoliative syndrom

[2.1.3]Ophthalmic conditions in the contra lateral eye:
[2.1.3.1]Best corrected visual acuity < 1/10
[2.1.3.2]Patient already included in the study for phakoexeresis
[2.1.3.3]History of ophthalmic surgical complication (cystoid macular oedema,..)

[2.1.4]Ophthalmic conditions in either eye:
[2.1.4.1]Presence of glaucoma and/or ocular hypertension history
Systemic/non ophthalmic non-inclusion criteria [2.2]
[2.2.1]General history:
[2.2.1.1]Diabetes mellitus
[2.2.1.2]Surdity
[2.2.1.3] Excessive anxiety
[2.2.1.4]Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasic, haematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities (such as unstable angina, uncontrolled hypertension: systolic blood pressure over 200 mmHG, diastolic blood pressure over 100 mmHg) etc... and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study
[2.2.2]Allergic history:
[2.2.2.1]Known hypersensitivity to one of the components of the study medications or to test products
[2.2.2.2]Allergic rhinitis

Study & Design

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