Two different toric IOLs from 2 different companies will be implanted and their final visual outcomes will be compared.
Phase 4
- Conditions
- Health Condition 1: H259- Unspecified age-related cataract
- Registration Number
- CTRI/2024/03/064570
- Lead Sponsor
- Biotech vision care pvt ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Unilateral and Bilateral Implantation
BCVA to be 0.2 Log Mar or Lower
Power withing the range of Investigational IOL
Stability of the cornea
Patients who have and will attend all follow-up appointments
Patients must sign and be given a copy of the written Informed consent form.
Exclusion Criteria
1. Preoperative ocular pathology
2. Ocular co-morbidities affecting visual outcome
3. Previous intra ocular or corneal surgery
4. Traumatic cataract
5. Corneal Opacities
6. Irregular astigmatism
7. instability of keratometry or biometry measurements;
8. Ophthalmic diseases such as Pseudoexfoliation, glaucoma,
traumatic cataract corneal scars and other co-morbidity that
could affect capsule bag stability
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Rotational Stability, <br/ ><br>2. Corrected and Uncorrected Visual Acuity <br/ ><br>3. Refraction and Refractive Astigmatism <br/ ><br>4. Spherical Equivalence <br/ ><br>5. Introcular pressure <br/ ><br>6. Change in Endothelial Cell countTimepoint: ? Visit 1- Post-operative Day 1-2 <br/ ><br>? Visit 2- Post-operative Day 7-14 <br/ ><br>? Visit 3- Post-operative Day 30-60 <br/ ><br>? Visit 4- Post-operative Day 120 to 180 <br/ ><br>? Visit 5-Post-operative Day 330 to 42
- Secondary Outcome Measures
Name Time Method Secondary Surgery due to early onset of PCOTimepoint: 3, 6 & 12 Months post surgery