Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery
NCT ID: NCT02101359
Last Updated: 2014-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
609 participants
INTERVENTIONAL
2011-06-30
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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T2380
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.
T2380
200 microlitres of T2380 will be administrated intracamerally
Tetracaine
Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery
Mydriatics and anesthetic
Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery.
Topical Mydriatic treatments were instilled three times before surgery.
Mydriatics
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.
Tetracaine
Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery
Interventions
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T2380
200 microlitres of T2380 will be administrated intracamerally
Mydriatics
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.
Tetracaine
Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female aged from 40 to 88 years old
* Scheduled to undergo unilateral cataract surgery
Exclusion Criteria
* Previous intraocular surgery
40 Years
88 Years
ALL
No
Sponsors
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Laboratoires Thea
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph COLIN
Role: PRINCIPAL_INVESTIGATOR
Marc LABETOULLE
Role: PRINCIPAL_INVESTIGATOR
Locations
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Laboratoires Thea
Clermont-Ferrand, , France
Countries
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References
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Labetoulle M, Behndig A, Tassignon MJ, Nuijts R, Mencucci R, Guell JL, Pleyer U, Szaflik J, Rosen P, Berard A, Chiambaretta F, Cochener-Lamard B; Intracameral Mydrane (ICMA), Ethics Group. Safety and efficacy of a standardized intracameral combination of mydriatics and anesthetic for cataract surgery in type-2 diabetic patients. BMC Ophthalmol. 2020 Mar 3;20(1):81. doi: 10.1186/s12886-020-01343-x.
Labetoulle M, Findl O, Malecaze F, Alio J, Cochener B, Lobo C, Lazreg S, Hartani D, Colin J, Tassignon MJ, Behndig A; Intracameral Mydrane Study 2 Group. Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery. Br J Ophthalmol. 2016 Jul;100(7):976-985. doi: 10.1136/bjophthalmol-2015-307587. Epub 2015 Nov 3.
Other Identifiers
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LT2380-PIII-05/10
Identifier Type: -
Identifier Source: org_study_id