TWO DIFFERENT TORIC IOLS FROM 2 DIFFERENT COMPANIES (TECHNIS AND BIOTECH) WILL BE IMPLANTED AND THEIR FINAL VISUAL OUTCOME WILL BE COMPARED
- Conditions
- Health Condition 1: H259- Unspecified age-related cataract
- Registration Number
- CTRI/2019/04/018671
- Lead Sponsor
- BIOTECH VISION CARE PVT LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method