To compare the visual outcomes between EYECRYL lens and RAYNER EMV/HOYA IOL in cataract surgery patients
- Conditions
- Health Condition 1: O- Medical and SurgicalHealth Condition 2: H259- Unspecified age-related cataract
- Registration Number
- CTRI/2024/06/068297
- Lead Sponsor
- BIOTECH VISION CARE PVT LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method