Health Condition 1: H251- Age-related nuclear cataract
Conditions
Interventions
Intervention1: Swiss Phob Toric Hydrophobic IOLs (Pre-loaded): UV and Blue light filtering Yellow Chromophore Hydrophobic acrylic IOL with square edge design.
OPTIC CHARACTERISTICS:
Optic Diameter:
Sponsors
Prof D Lional Raj
Eligibility
Inclusion criteria
Inclusion criteria: 1. Cataractous lens changes as demonstrated by best corrected visual acuity of 20/40 or worse either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract-related visual symptoms; 2. Best corrected visual acuity to be better than 20/30 after cataract removal and IOL implantation as estimated by potential acuity meter (PAM) or surgeon estimation Have corneal thickness more than600 m by OCT 3. Less than or equal to 1.0 D of preoperative keratometric astigmatism 4. Clear intraocular media other than cataract 5. Given written informed consent by subject. 6. Subjects are willing and able to comply with schedule for follow up visits 7. Subjects should be 22 years or older
Exclusion criteria
Exclusion criteria: 1. Systemic disease that could increase the operative risk or confound the outcome; 2. Systemic medications that may confound the outcome or increase the risk to the subject in the opinion of the investigator [tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome)]; 3. Ocular condition that may predispose for future complications 4. Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject 5. Pregnant, lactating during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes; 6. Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity loss to 20/30 or worse 7. Subjects with conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the lens; 8. If preclinical testing or risk analysis indicates potential for substantially increased light scatter over a monofocal lens, then exclude subjects who are expected to require retinal laser treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Best Corrected distance visual acuity (BCDVA) @ 6 m (20 Foot) 2. Distance Corrected Intermediate visual acuity (DCIVA) @ 66 cm 3.Corrected Near Visual Acuity (CNVA) @ 40 cm Timepoint: BCDVA: Preoperative and Post-Operative: Day 1, Week 1, Month 1,3 & 12. DCIVA & CNVA - Post-Operative: Month 1,3 & 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient satisfaction and quality of vision, using McAlindens & subjective feed back questionnaire. Anterior Capsule Contraction Syndrome.Timepoint: Post-Operative: Month 1, Month 3 & Month 12 | — |
Countries
India
Contacts
Public ContactProf A Heber
Dr. Agarwals Eye Hospital
Outcome results
None listed