A PROSPECTIVE,COMPARATIVE RANDOMISED CLINICAL STUDY TO EVALUATE THE SAFETY,EFFICACY AND REFRACTIVE OUTCOME OF TWO DIFFERENT TORIC IOLS IMPLANTED INTO PATIENTS WITH CATARACT AND CORNEAL ASTIGMATISM - REFRACTIVE COMPARISION OF TWO TORIC IOLS

BIOTECH VISION CARE PVT LTD0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1Unilateral
•2Adult patient
•3Best corrected visual acuity projected to be 0.2 logMAR or lower
•4Calculated IOL power is within the range of the investigational IOL
•5Stability of the cornea has been demonstrated by keratometry
•6Expected dilated pupil size at least large enough to visualize the axis markings
•7Corneal cylindrical error within the range defined in the clinical investigation plan
•8Patient must have preoperative regular corneal astigmatism from 0.5 to 4.50 D as per corneal topography or keratometry
•9Patients who have and will attend all follow-up appointments
•10Patients must sign and be given a copy of the written Informed Consent form

•1Preoperative ocular pathology
•2Presence of irregular corneal astigmatism
•3Ocular co-morbidities affecting visual outcome
•4Previous intra ocular or corneal surgery
•5Traumatic cataract
•6Corneal Opacities
•7Ophthalmic diseases such as pseudoexfoliation, glaucoma, traumatic cataract corneal scars and other co-morbidity that could affect capsule bag stability
•8Pre-existing corneal astigmatism lesser than 0.75 D
•9Pre-existing retinal disease
•10Pregnant & Lactating women
•11Concurrent participation in another drug or device investigation

发起方

BIOTECH VISION CARE PVT LTD