A study to test effectiveness and safety of a solution which expands patients eyes pupils during manual operation for cataract
Phase 3
Completed
- Conditions
- Health Condition 1: null- Cataract
- Registration Number
- CTRI/2016/06/007036
- Lead Sponsor
- M S Ramaiah Hospital medical college
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 118
Inclusion Criteria
Patients scheduled for elective MSICS, after screening for exclusion criteria, and after obtaining their informed consent
Exclusion Criteria
Pregnancy/breast feeding, uveitis, intake of alpha blockers, use of topical or systemic NSAIDs/prostaglandins/ miotics, presence of corneal opacities, pupillary deformities, pseudoexfoliation, past history of surgery in same eye and hypersensitivity to any component of medicines used.
Any eye not dilating to at least 6 mm preoperatively, and eyes where intraoperative complications such as iris trauma or vitreous loss are encountered, will be excluded from the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of pupil diametersTimepoint: 1)Just before injecting local anaesthesia <br/ ><br>2)Just before incision into anterior chamber <br/ ><br>3)One minute after entry into anterior chamber <br/ ><br>4)Just after extracting nucleus from anterior chamber to exterior <br/ ><br>5)Just before implanting Intraocular lens <br/ ><br>6)Just before removing eye speculum
- Secondary Outcome Measures
Name Time Method Assessment of the postoperative inflammation and evaluation of patient satisfaction with the surgery through a feedback form, on first postoperative dayTimepoint: Twenty-four hours after surgery