Health Condition 1: H259- Unspecified age-related cataract
Conditions
Interventions
Intervention1: EYECRYL PLUS (600) 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-operative
Sponsors
Biotech vision care pvt ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Adult patient, 18 years old or older will be enrolled in the study 2 Patient with cataract 3 Calculated IOL power is within the range of the study IOL 4 Patients must sign and be given a copy of the written Informed Consent form 5 Clear intraocular media other than cataract 6 Patient willing to undergo the investigations and comply with the follow-up schedule
Exclusion criteria
Exclusion criteria: 1 Previous intraocular or corneal surgery 2 Pregnancy or lactation 3 Concurrent participation or participation in the last 30 days in any other clinical trial 4 Irregular astigmatism 5 instability of keratometry or biometry measurements 6 Vulnerable subjects 7 Patients receiving chloroquine treatment
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 months 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 months post operatively. | — |
Countries
India
Contacts
Public ContactMR BHARGAV JOSHI
BIOTECH VISION CARE PVT LTD
Outcome results
None listed