A Phase IV, Multicentre, Open Label Clinical Study to Evaluate The Safety and Efficacy of Intracameral Phenocaine Plus Injection for Anaesthesia and Mydriasis in Cataract Surgery.

Entod Pharmaceuticals Ltd0 sites0 target enrollmentTBD

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Health Condition 1: H28- Cataract in diseases classified elsewhere
Sponsor: Entod Pharmaceuticals Ltd
Status: Completed
Last Updated: 3 years ago

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

3 years ago

Study Type

Pms

Sponsor

Entod Pharmaceuticals Ltd

•1\.Male or female subjects of age between 18 to 75 years (both inclusive).
•2\.Subjects having grade 2 to 3 Cataract shall be included.
•3\.Subjects scheduled to undergo surgery for cataract.
•4\.Endothelial cell count \> 2000 cell/mm2\.
•5\.Pupil diameter \>\= 7 mm at screening.
•6\.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures

•1\.Corrected visual acuity \< 0\.5\.
•2\.Refractive Error with a spherical equivalent \> \+6 or smaller \- 6 D.
•3\.Elevated intraocular pressure (higher than 22 mmHg).
•4\.Current or history within two months prior to baseline of significant ocular disease, e.g., corneal denervation, corneal epithelial defects, dry eye syndrome, ocular trauma to the operative eye, corneal edema, proliferative diabetic retinopathy in the operative eye or ocular infection.
•5\.In the operative eye, history of chronic or recurrent inflammatory disease, e.g., iritis, scleritis, uveitis, iridocyclitis or rubeosis iritis, lens pseudoexfoliation syndrome with glaucoma or zonular compromise of. Congenital ocular anomaly, e.g., aniridia or congenital cataract.
•6\.Iris atrophy in the operative eye.
•7\.Combined surgery
•8\.Clinically significant ocular endothelial dysfunction.
•9\.History of eye surgery apart from laser trabeculoplasty less than three months previously or extraocular surgery such as strabismus surgery.
•10\.Topical ocular medication influencing IOP (intraocular pressure) or pupil size within 3 months prior to study\-start.

Not specified