Evaluation of efficacy, safety and anaesthetic effect of esolution administered during cataract surgery.

• Conditions: subjects with cataract; MedDRA version: 14.1Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2010-021188-34-IT
• Lead Sponsor: ABORATORIES THEA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-27
• Last Update Posted: 16 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 492

Inclusion Criteria

Signed and dated informed consent;Male or female aged from 40 to 88 years old; Scheduled to undergo unilateral cataract surgery (Under topical anesthesia and using clear corneal self sealing incisions - phacoemulsification – foldable intra-ocular lens surgery with injector); Pupil diameter = 7 mm at selection visit [after the following dilatation protocol: 1 tropicamide 0.5% + 1 drop phenylephrine 10%; with a maximum of 3 combined instillations with interval of 10 mn, i.e. T 0mn, + T 10mn and + T 20mn if necessary]
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

Ophthalmic non-inclusion 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. - Pupillary abnormalities (irregular,..) - Very dark iris - Iris synechiae - Eye movement disorder (Nystagmus,..) - Dacryocystitis and all others pathologies of tears drainage system - History of Inflammatory ocular disease (Iritis, 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 - Pseudoexfoliation, exfoliative syndrome, ? 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 (cystoid macular oedema,..) ? Presence of glaucoma and/or ocular hypertension history in either eye Systemic/non ophthalmic non-inclusion criteria None of the following criteria ? General history: - Diabetes not controlled - Insulin-dependent diabetes - Surdity - Excessive anxiety - 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 arterial hypertension etc...) and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study ? Allergic history: - Known hypersensitivity to one of the components of the study medications or to test products - Allergic rhinitis Specific non-inclusion criteria for women - Pregnancy, lactation - Women without an effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) OR - Women not hysterectomised, menopaused or surgically sterilized Non-inclusion criteria related to general conditions - Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent - Non compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance) - Participation in another clinical study - Already included once in this study - Ward of court - Patient not covered by the Social Security scheme (For France)

Study & Design

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