Health Condition 1: H259- Unspecified age-related cataract
Conditions
Interventions
Intervention1: Tropicamideâ??Phenylephrine-Lidocaine (Phenocaine Plus) injection: Phenocaine Plus Injection is
intended for rapid and stable mydriasis and sustained intraocular anesthesia during
surge
Sponsors
Entod Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients having cataract and willing to sign informed consent. Patients between the age 18 to 75 years. Patients must be able to communicate effectively with study personnel. Patients having grade 2 to 3 Cataracts shall be included. Patients scheduled to or taking surgery for cataract.
Exclusion criteria
Exclusion criteria: Ophthalmological criteria: 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) Relevant anisocoria or pupil deformation 5) History of eye surgery apart from laser trabeculoplasty less than three months previously or extraocular surgery such as strabismus surgery 6) Topical ocular medication influencing IOP (intraocular pressure) or pupil size within 3 months prior to study-start 7) Combined surgery Non-surgical conditions in the eye to be operated 8) Iatrogenic or traumatic or congenital cataract 9) Pupillary abnormalities (irregular) 10) Very dark iris - Iris synechiae 11) Eye movement disorder (Nystagmus) 12) Dacryocystitis and all others pathologies of tears drainage system 13) History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis) 14) Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis 15)s - Pseudoexfoliation, exfoliative syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Variables: 1. Observing any side effects or adverse events during and post surgery. 2. Questioning about any number of supplementary drops or injection necessary to maintain mydriasis and/or anesthesia. 3. Details of any rescue treatment required to be provided to subject during surgery. 4. Assessment of surgeonâ??s satisfaction and patient discomfort at each stage of surgery.Timepoint: post op surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Any adverse event observed after the surgeryTimepoint: Follow-up visit after surgery on 1 day, 1 week, 1 month | — |
Countries
India
Contacts
Public ContactDr Namrata Sharma
AIIMS
Outcome results
None listed