Health Condition 1: H251- Age-related nuclear cataract
Conditions
Interventions
Intervention1: OPTIFLEX GENESIS COMFORT NY intraocular lens: These IOLs are designed to be surgically implanted one time into the human eye as a replacement for the natural crystalline lens.
Frequency
Sponsors
Dr Abhay R Vasavada
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient aged 40 years or older 2. Clear Intraocular Media other than Cataract 3. Calculated IOL power is within the range of +5.0 to +30.0 D 4. Patient willing to participate and sign informed consent 5. Patient willing to come for all post-operative follow-up 6. 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) Pre-existing corneal astigmatism of more than 0.75 diopters
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual performance following in the bag implantation of the preloaded Optiflex Genesis Comfort NY IOLTimepoint: Patients will be followed-up for following schedule: 1 Pre-operative Visit/Screening Visit 2 Intra-operative/Surgery Visit 3 Post-operative 1 Day 4 Post-operative 1 Week ± 3 Days 5 Post-operative 1 Month ± 7 Days 6 Post-operative 3 Months ± 7 Days 7 Post-operative 6 Months ± 7 Days 8 Post-operative 12 Months ± 15 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative performance and postoperative complications following in the bag implantation of the preloaded Optiflex Genesis Comfort NY IOLTimepoint: Patients will be followed-up for following schedule: 1 Pre-operative Visit/Screening Visit 2 Intra-operative/Surgery Visit 3 Post-operative 1 Day 4 Post-operative 1 Week ± 3 Days 5 Post-operative 1 Month ± 7 Days 6 Post-operative 3 Months ± 7 Days 7 Post-operative 6 Months ± 7 Days 8 Post-operative 12 Months ± 15 Days | — |
Countries
India
Contacts
Public ContactAbhay R Vasavada
Raghudeep Eye Hospital
Outcome results
None listed