Health Condition 1: H259- Unspecified age-related cataract
Conditions
Interventions
Intervention1: Preloaded Hydrophobic EDOF Toric Lens: Total duration is 12 months
Preloaded Hydrophobic EDOF Toric Lens are single piece posterior chamber IOLs. The overall diameter of the lens is 13
Sponsors
Biotech vision care pvt ltd
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 3. 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 woman 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 |
|---|---|
| Binocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm).Timepoint: ï??Pre-operative Visit/Screening Visit ï??Surgery Visit/Intra-operative Visit ï??Day 1 (1 - 2 days post-operative) ï??Week 1 (7 - 14 days post-operative) ï??Month 1 (30 - 60 days post-operative) ï??Month 6 (120 - 180 days post-operative) ï??Month 12 (330 - 420 days post-operative) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Uncorrected distance visual acuity (UCDVA) [photopic] 2) Uncorrected intermediate visual acuity (UCIVA) [photopic] 3) Best corrected distance visual acuity (BCDVA) [photopic] 4) Uncorrected Near visual acuity (UCNVA) [photopic] 5) Distance corrected Near visual acuity (DCNVA) [photopic] 6) Distance-corrected intermediate visual acuity (DCIVA) [photopic] 7) Low Contrast (10%) Distance Corrected Intermediate Visual Acuity [photopic] 8) Low Contrast (10%) Best Corrected Intermediate Visual Acuity [photopic] 9) Defocus curves monocular and binocular 10) Manifest refraction 11) Subject questionnaire 12) Subject ocular and visual symptoms (non-directed questions) 13) Rotational stability 14) Spherical equivalent Timepoint: ï?? Pre-operative Visit/Screening Visit ï?? Surgery Visit/Intra-operative Visit ï?? Day 1 (1 - 2 days post-operative) ï?? Week 1 (7 - 14 days post-operative) ï?? Month 1 (30 - 60 days post-operative) ï?? Month 6 (120 - 180 days post-operative) ï?? Month 12 (330 - 420 days post-operative) | — |
Countries
India
Contacts
Public ContactMr. Bhargav Joshi
Narayana Nethralaya Banglore
Outcome results
None listed