CTRI/2023/11/060182
Not yet recruiting
Phase 4
A prospective, open-label, single-arm clinical study to evaluate the performance & safety of Eyevisc 2.4% OVD in patient undergoing cataract surgery - NI
Biotech Ophthalmics Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: H251- Age-related nuclear cataract
- Sponsor
- Biotech Ophthalmics Pvt Ltd
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Unilateral/Bilateral
- •2\) Age \= 45 year or greater.
- •3\) Cataract for which phacoemulsification extraction and posterior
- •chamber IOL implantation was planned in at least one eye of the
- •patient. 4\) Clear intraocular media other than cataract.
- •5\) Signed informed consent. 6\) Patient who are willing to attend all the regular follow\-up
- •examinations as per the study schedule.
- •7\) Patients with Grade I to III cataract and used OVDs
- •8\) Patients that have healthy eyes excluding the formation of cataract.
- •9\) Given consent to use device related data for scientific purpose.
Exclusion Criteria
- •1\) Concurrent participation or participation in the last 30 days in any
- •other clinical trial.
- •2\) History of previous steroid \- induced IOP
- •3\) Patient with pigment dispersion syndrome
- •4\) Taking medications that may affect vision, IOP, or ease of cataract
- •surgery (e.g., Flomax, glaucoma medications, etc.)
- •5\) Acute or chronic disease or illness that would increase risk or
- •confound study results (e.g., diabetes mellitus,
- •immunocompromised, etc.).
- •6\) Uncontrolled systemic or ocular disease.
Outcomes
Primary Outcomes
Not specified
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