Health Condition 1: H251- Age-related nuclear cataract
Conditions
Interventions
Intervention1: Intensity Pentafocal IOL: The patient undergoing cataract surgery via phacoemulsification is implanted with a hydrophobic pentafocal intraocular lens.
Control Intervention1: PanOptix Tr
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 year or greater 2. Patients with bilateral age related cataracts, require bilateral cataract phacoemulsification combined Intraocular Lens implantation; 3. Patients with axial length of 22 - 24.5mm 4. Normal corneas with less than 1.00 D of regular corneal astigmatism 5. Post-operative best corrected visual acuity projected to be 0.3 log MAR or lower 6. Fundus visualization is possible 7. Absence of retinal or optic nerve diseases
Exclusion criteria
Exclusion criteria: 1. Previous intraocular or corneal surgery that may affect refraction accuracy or visual acuity 2. Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens 3. History or evidence of any ocular disease that may affect visual acuity 4. Rubella cataract 5. Amblyopia 6. Any other ocular condition that may predispose a subject to future complications or contraindicate implantation of the Intensity SL lens 7. Pupil abnormalities 8. Patients with pupil diameter greater than 4 mm in photopic conditions 9. Pregnant, lactating, or planning to become pregnant during the course of the trial 10. Allergy or intolerance to required study medications 11. Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days 12. Traumatic cataract 13. Irregular astigmatism 14. Instability of keratometry or biometry measurements 15. Patients receiving chloroquine treatment 16. Patient having Microphthalmia 17. Patient having Chronic Uveitis 18. Patient suffering from Corneal dystrophy or endothelial insufficiency. 19. Patient having active ocular diseases (active diabetic retinopathy, uncontrolled glaucoma)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Uncorrected Distance Visual Acuity (UDVA) @ 6 m (20 Foot) 2. Uncorrected Intermediate Visual Acuity (UIVA) @ 66 cm 3. Uncorrected Near Visual Acuity (UNVA) @ 40 cmTimepoint: Post-Operative: Month 1, Month 6 & Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient satisfaction and quality of vision between the two IOLs, using McAlindens. spherical aberration of intraocular lenses is measured using wavefront aberrometry. Visual performance by De-Focus curve.Timepoint: Post-Operative: Month 1, Month 6 & Month 12 | — |
Countries
India
Contacts
Public ContactProf A Heber
Dr. Agarwals Eye Hospital
Outcome results
None listed