CTRI/2023/03/050394
Recruiting
Phase 4
A prospective, open-label clinical study to evaluate performance and safety of the Phacoemulsification Machine with Accessories.
Grewal Eye Institute0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: H259- Unspecified age-related cataract
- Sponsor
- Grewal Eye Institute
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Cataracts for which cataract extraction
- •and posterior chamber IOL implantation
- •have been planned \& possible
- •2\.Availability, willingness, ability and
- •sufficient cognitive awareness to comply
- •with study requirements, examination
- •procedures and visits
- •4\.Be willing to provide informed consent and
- •authorization to disclose protected health
- •information or equivalent documentation
Exclusion Criteria
- •1\. Preoperative ocular pathology that can affect visual acuity
- •2\. Corneal irregularities such as keratoconus, corneal dystrophy,
- •corneal opacities
- •3\. Previous intraocular or corneal surgery
- •4\. Other ocular surgery at the time of the cataract extraction
- •5\. Subject with acute and chronic disease or illness that would
- •increase the operative risk or confound the outcomes of the
- •6\. Subject with primary open angle or narrow angle glaucoma
- •7\. Patient with cardiac pacemaker
- •8\. Previous or pre\-existing ocular disease that would preclude post operative visual acuity of 20/60 or better subject with
Outcomes
Primary Outcomes
Not specified
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