Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Tropicamide 0.2mg/ml, Phenylephrine HCl 3.1mg/ml, Lidocaine HCl 10mg/ml: Single dose of study product injected into the anterior chamber of
eye at the beginning of the cataract surgery
Sponsors
Sunways India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Signed informed consent prior to any study-mandated procedure. 2.Male or female aged 18 years and 65 years (both inclusive). 3.Cataract of any grade and type requiring cataract surgery indiscretion of Study Investigator. 4.No secondary procedure planned (i.e. trabeculectomy,keratectomy,corneal transplant,vitreoretinal procedure etc.) 5.Systemic condition capable of undergoing topical anesthesia 6.No previous intraocular surgery
Exclusion criteria
Exclusion criteria: 1.Any iris pathology including but not limited to posterior synechia,iridocorneal endothelial syndrome,corectopia,traumatic mydriasis,Horners syndrome,Adies pupil,cyclodialysis,iridodialysis 2.Corneal pathology affecting pupil magnification or measurement (keratoconus, peripheral thinning,sclerocornea,scarring) 3.Known hypersensitivity to any of the individual formulation of Investigational product. 4.Uncontrolled Hypertension as judged by investigator 5.Pregnant and/ or Lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pupil sizeTimepoint: Time Frame: At beginning, post Investigational product administration, every 5 minutes till next 30 minutes and completion of cataract surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Intraoperative pain 2.Assessment of Clinical Global Impression scale change from baseline 3.Clinical Adverse events throughout the studyTimepoint: 1. Time Frame: 1 hour post surgery | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
CliniExperts Research Services Private Limited
Outcome results
None listed