Health Condition 1: H00-H59- Diseases of the eye and adnexa
Conditions
Interventions
Intervention1: AcrySof IQ PanOptixToric IOL: To characterize the visual outcomes of PanOptixToric Multifocal IOL implanted to replace the natural lens in cataract patients
Control Intervention1: NOT A
Sponsors
NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL BANGALORE
Eligibility
Inclusion criteria
Inclusion criteria: 1. Regular corneal topography and corneal astigmatism from 0.75 D to 4.00 D. 2. Best Corrected Visual Acuity to be 0.2 LogMAR or lower 3. Clear intraocular media 4. Availability, willingness and sufficient cognitive awareness to comply with examination procedures
Exclusion criteria
Exclusion criteria: 1. Any active ocular disease 2. Diabetic retinopathy, retinal degenerative disorders, macular degeneration, glaucoma with field defects 3. Irregular corneal astigmatism( keratoconus/ PMD) 4. Previous intraocular and corneal refractive surgery 5. Pregnancy & Lactation 6. Traumatic , Intumescent and white Cataracts 7. Subject who have retinal pathologies or dystrophies and those who are expected to require retinal laser treatment 8. Concurrent participation in another drug or device study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: 3 Months post 2nd eye Surgery:- Corrected photopic distance visual acuity (CDVA, binocular) Timepoint: Pre-opertative/ intra-opera visits and post-operative days 1, 15, 90, 180, 365 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Uncorrected and corrected photopic distance, intermediate and near visual acuity 2. Improvement in Quality of Life (Quality of Life Questionnaire developed by Rasch Analysis) 3. Refractive astigmatism 4. Spherical Equivalent 5. Binocular Defocus CurveTimepoint: 3 Months post 2nd eye surgery Post-operative visits | — |
Countries
India
Contacts
Public ContactDR SRI GANESH
NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL, BANGALORE
Outcome results
None listed