CTRI/2019/12/022318
Not yet recruiting
Phase 4
A prospective, comparative, randomized clinical study to compare and evaluate the safety, efficacy and refractive outcome of three different Hydrophilic Monofocal Intraocular Lens implanted to cataract patients. - BTVCPL-HFIOL-2019-02
Biotech Vision Care Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: H259- Unspecified age-related cataract
- Sponsor
- Biotech Vision Care Pvt Ltd
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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