Comparison of Preservative-free Non-Steroidal Anti-Inflammatory Drug and Preservative-free Corticosteroid after Cataract Surgery

Not Applicable

Completed

• Conditions: Diseases of the eye and adnexa

• Registration Number: KCT0003340
• Lead Sponsor: The Catholic University of Korea, Yeouido St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

1. bilateral senile cataract (=50 years old) with nuclear opalescence/color 3~4 and no posterior subcapsular cataract according to the Lens Opacities Classification System III scale
2. scheduled to get cataract surgeries for both eyes with less than 7day interval between the two
3. corneal endothelial density =1,500 cells/? for both eyes
4. volentary agreement with signed informed consent

Exclusion Criteria

1. current or history of ocular disorders possibly affecting the study results(ocular surgery, malformation or diseases)
1) eye trauma, corneal transplantation
2) congenital cataract, aniridia, iris atrophy
3) visual acquity affecting retinal disease like diabetic retinopathy, epiretinal membrane, retinal edema etc
4) pseudoexfoliation syndrome
5) other inappropriate conditions by ophthalmologist's judge
2. medical condition to be treated with topical agents besides artifical tear within 2 weeks from cataract surgery and during the study period
1) chronic or recurrent ocular inflammatory diseases lik uveitis, scleritis etc
2) glaucoma, ocular allergy, dry eye to be treated with drops
3. systemic diseases affecting the study results
1) uncontrolled diabetes or hypertension
2) conditions to take systemic steroid or NSAID(non-steroidal anti-inflammatory drug) within 2 weeks(45 days for delayed releasing formulation) from cataract surgery and during the study period
4. investigator's judge to be treated with intensive anti-inflammatory therapy after surgery (surgery complication like posterior capsular rupture, vitreous loss etc)
5. known hypersensitivity to study medications
6. clinical study participants within 6 months
7. pregnancy or lactation
8. investigator's judge of inappropiation

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
anterior chamber inflammation grade(flare grade+cell number grade)

Secondary Outcome Measures

Name	Time	Method
anterior chamber inflammation grade(flare grade+cell number grade);% of patients with no anterior chamber inflammation;corrected distance visual acuity in logMAR(minimal angle of resolution);corneoconjunctival signs (corneal edema, central corneal thickness change, bulbar redness, corneoconjunctival staining score, tear break-up time);patient evaluations (postoperative ocular discomfort, postoperative visual discomfort, instillation tolerability);foveal thickness change;PCO(posterior capsular opacification);postoperative ocular pain;IOP(intraocular pressure) change;% of patients drop-outed for intensive inflammatory therapy;adverse event during study drug treatment (including study drug related adverse event during follow-up period)