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.

Phase 3

Not yet recruiting

• Conditions: Unspecified age-related cataract,

• Registration Number: CTRI/2020/01/022874
• Lead Sponsor: Dr DINKAR BERI

Brief Summary

This study is a randomized, open label, parallel group, single centered, trial comparing the efficacy and safety of prednisolone acetate 1%, loteprednol etabonate 0.5%, dexamethasone 0.1% and difluprednate 0.05% eye drops in post-operative ocular inflammation following cataract surgery for six weeks in 140 patients randomized into 4 groups at department of ophthalmology, KIMS Hospital, VV Puram, Bangalore 560004, India. The primary outcome measures will be **Efficacy parameters :**Anterior chamber cell and flare grading as per standardization of uveitis nomenclature (SUN), Ocular pain assessed by Visual Analogue Scale (VAS).

at six weeks.

The secondary outcome measures will be

**Safety and tolerability parameters :**Intraocular Pressure measured with applanation tonometry, Adverse drug event monitoring.

at six weeks.

Even though there are many studies which have established the efficacy of the commonly used topical corticosteroids, there have been few systematic studies conducted to assess the efficacy and safety of these drugs in postoperative ocular inflammation following cataract surgery in Indian population. Hence, this present study is proposed to be taken up.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-01-16
• Study Start: 2020-01-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• 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.

Exclusion Criteria

• 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:	6 weeks.
2.Ocular pain assessed by Visual Analogue Scale (VAS).	6 weeks.
1.Anterior chamber cell and flare grading as per standardization of uveitis nomenclature (SUN).	6 weeks.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability parameters:	1.Intraocular Pressure measured with tonometry.

Trial Locations

Locations (1)

KIMS HOSPITAL; 🇮🇳 Bangalore, KARNATAKA, India

KIMS HOSPITAL

🇮🇳Bangalore, KARNATAKA, India

Dr DINKAR BERI

Principal investigator

8427466335

dinkarberi85@gmail.com