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

Comparison of Preservative-free Non-Steroidal Anti-Inflammatory Drug and Preservative-free Corticosteroid after Uncomplicated Cataract Surgery : A multicenter, Randomized, Evaluator-blinded, Between-two-eye Clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003340

Enrollment

123

Registered

2018-11-13

Start date

2018-11-07

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : On randomization plan, one eye is allocated to preservative-free NSAID(non-steroidal anti-inflammatory drug) treated eye while the opposite eye is to preservative-free steroid treated eye -. Pr

ophthalmic solution(Single Unit Dose), 1 drop/time, 4 times/day, 4 weeks, ophthalmic

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
anterior chamber inflammation grade(flare grade+cell number grade)	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Korea, Republic of

Contacts

Public ContactHyun-Seung Kim

The Catholic University of Korea, Yeouido St. Mary's Hospital

Outcome results