A study to compare the effectiveness, benefits and risks of four eye drops prednisolone acetate 1%, dexamethasone 0.1%, loteprednol etabonate 0.5% and difluprednate 0.05% in patients with red, swollen, painful eyes after cataract surgery.
- Conditions
- Health Condition 1: H259- Unspecified age-related cataract
- Registration Number
- CTRI/2020/01/022874
- Lead Sponsor
- Dr DINKAR BERI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Subjects with senile cataract with an indication for cataract extraction.
2.Subjects willing to give informed consent and be available for regular follow up.
1.Subjects with congenital and traumatic cataract.
2.Subjects with recurrent infectious and/or inflammatory eye diseases.
3.Subjects with uncontrolled diabetes or associated with complications.
4.Subjects with history of auto-immune diseases.
5.Subjects who are immunocompromised or having tuberculosis, human immunodeficiency virus (HIV) infection.
6.Subjects who develop intra-operative complications during surgery.
7.Subjects with history of hypersensitivity to study drugs.
8.Subjects with history of steroid use 14 days prior to surgery.
9.Subjects with active ocular and/or ENT infections.
10.Subjects with uncontrolled glaucoma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy parameters: <br/ ><br>1.Anterior chamber cell and flare grading as per standardization of uveitis nomenclature (SUN). <br/ ><br>2.Ocular pain assessed by Visual Analogue Scale (VAS). <br/ ><br>Timepoint: 6 weeks.
- Secondary Outcome Measures
Name Time Method Safety and tolerability parameters: <br/ ><br>1.Intraocular Pressure measured with tonometry. <br/ ><br>2.Adverse drug event monitoring. <br/ ><br>Timepoint: 6 weeks