Health Condition 1: H259- Unspecified age-related cataract
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 year or greater 2. Cataract 3. Calculated IOL power is within the range of the Study IOL. 4. Clear intraocular media other than cataract 5. Patient willing to participate and sign informed consent to participate in study and to use device related data for scientific purpose 6. Patient willing to come for all post-operative follow-up 7. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study
Exclusion criteria
Exclusion criteria: 1. Previous intraocular or corneal surgery 2. Traumatic cataract 3. Pregnancy 4. Concurrent participation or participation in the last 30 days in any other clinical trial 5. Subjects who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than YAG capsulotomy) 6. Gonioscopic abnormalities 7. Irregular astigmatism. 8. Instability of keratometry or biometry measurements. 9. History of intraocular inflammation. 10. Vulnerable subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subject achieving distance uncorrected visual acuity within (0.2 logMAR or better) at 180 days post operatively.Timepoint: Post operative 1 day, 7 day, 1 month and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subject achieving distance Best spectacle corrected visual acuity within (0.2 logMAR or better) at 180 days post operatively.Timepoint: Post operative 7 day, 1 month | — |
Countries
India
Contacts
BIOTECH VISION CARE PVT LTD