To compare and evaluate the safety, efficacy and refractive outcome of three different Hydrophilic Monofocal Intraocular Lens implanted to cataract patients.
- Conditions
- Health Condition 1: H259- Unspecified age-related cataract
- Registration Number
- CTRI/2019/12/022318
- 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.Unilateral/Bilateral Cataract
2.Patients with age > 50 years.
3.Patients with Grade I or Grade II cataract as per Lens Opacities Classification System III (LOCS-III).
4.Patients that have healthy eyes excluding the formation of senile cataract.
5.Patient who are ready to attended all the regular follow-up examinations as per the routine schedule.
1.Patients receiving Chloroquine treatment.
2.Preoperative corneal astigmatism > 1.
3.Baseline endothelial cell density < 1500 cells/mm2 in the operative eye.
4.Amblyopia, Microphthalmia, Glaucoma, Pseudoexfoliation Syndrome with Glaucoma, Iris atrophy, Proliferative diabetic retinopathy and all retinal pathologies.
5.A history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, Iridocyclitis, rubeosis iritis).
6.Previous intra-ocular or corneal surgery.
7.Pregnant or lactating mother.
8.Concurrent participation in another drug or device Study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) Visual Acuity <br/ ><br>(2) Refraction <br/ ><br>(3) Spherical EquivalentTimepoint: Pre-op, 15 days, 1, 3, 6 & 12 <br/ ><br>Months post-surgery
- Secondary Outcome Measures
Name Time Method (1) Intraocular Pressure <br/ ><br>(2) Change in Endothelial cell count <br/ ><br>(3) Fundus Visualization <br/ ><br>(4) PCO <br/ ><br>Timepoint: Pre-op, 15 days, 1, 3, 6 & 12 <br/ ><br>Months post-surgery