Health Condition 1: H259- Unspecified age-related cataract
Conditions
Interventions
Intervention1: EYECRYL PLUS (ASHFY600) intraocular lens: Total duration of study is 24
months, visit schedule is
Pre-operative Visit/Screening Visit
Surgery Visit
Post-operative 1 to 2 Days
Post-ope
Sponsors
Biotech vision care pvt ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Age 18 year or greater 2 Cataract 3 Calculated IOL power is within the range of the investigational IOL. 4 Given consent to use device related data for scientific purpose 5 Clear intraocular media other than cataract 6 Patient willing to participate and sign informed consent to participate in study and to use device related data for scientific purpose 7 Patient willing to come for all post-operative follow-up
Exclusion criteria
Exclusion criteria: 1 Previous intraocular or corneal surgery 2 Traumatic cataract 3 Pregnancy or lactation 4 Concurrent participation or participation in the last 30 days in any other clinical trial 5 Irregular astigmatism 6 Instability of keratometry or biometry measurements 7 Vulnerable subject. 8 Patients receiving chloroquine treatment. 9 Patient having Microphthalmia. 10 Patient having Chronic Uveitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subject achieving distance corrected visual acuity of 0.3 logMAR or better at 12 months post operatively.Timepoint: 12 Month Post operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of best-case subjects achieving best corrected distance visual acuity of 0.3 logMAR or better at 12 months post operatively.Timepoint: 12 Month Post operatively | — |
Countries
India
Contacts
Public ContactMR BHARGAV JOSHI
BIOTECH VISION CARE PVT LTD
Outcome results
None listed