Health Condition 1: O- Medical and Surgical Health Condition 2: H259- Unspecified age-related cataract
Conditions
Interventions
Intervention1: EYECRYL Sert intraocular lens Intraocular Lens: Preloaded monofocal Hydrophobic Aspheric EDOF (Extended depth of focus) lens will be placed during cataract surgery and patients will be
Sponsors
BIOTECH VISION CARE PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients having cataract (2) Potential postoperative BCDVA of 0.2 logMAR (20/32 Snellen) or better in each eye based on Investigator’s medical opinion
Exclusion criteria
Exclusion criteria: (1) Systemic disease that could increase the operative risk or confound the outcome; (2) instability of keratometry or biometry measurements; and (3) irregular astigmatism. (4) 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)); (5) Ocular condition that may predispose for future complications (6) Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject; (7) Pregnant, lactating during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes; (8) 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 (9) 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; (10) 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; (11) Concurrent participation in another drug or device study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Distance Corrected Intermediate Monocular Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions (Mean Monocular DCIVA@66cmTimepoint: 180 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. In the study group, 50% of eyes achieving photopic monocular Distance Corrected Intermediate Visual Acuity (DCIVA) 0.2 logMAR or better @66 cmTimepoint: 120-180 days | — |
Countries
India
Contacts
Public ContactDr Namrata Sharma
AIIMS, New Delhi
Outcome results
None listed