MedPath

A clinical study to evaluate efficacy and safety of Tropicamide, Phenylephrine, Lidocaine intracameral injection in patientsundergoing cataract surgery.

Phase 4
Conditions
Health Condition 1: O- Medical and Surgical
Registration Number
CTRI/2021/11/037890
Lead Sponsor
Sunways India Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
0
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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