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Loteprednol etabonate gel 0.5% vs prednisolone acetate suspension 1% for the treatment of inflammation after cataract surgery in children
- Source :
- Journal of cataract and refractive surgery. 46(8)
- Publication Year :
- 2020
-
Abstract
- Purpose To compare loteprednol etabonate (LE) gel 0.5% with prednisolone acetate suspension (PA) 1% for the treatment of inflammation after cataract surgery in children. Setting Eleven sites in the United States. Design Randomized, double-masked, parallel-group, noninferiority study. Methods Eligible patients were aged 11 years or younger and candidates for routine, uncomplicated cataract surgery. Patients were randomized to a 4-week postsurgical regimen with LE gel 0.5% or PA 1%, twice on the day of surgery, 4 times daily for 2 weeks, twice daily for 1 week, and once daily for 1 week. Assessments included anterior chamber (AC) cells/flare, anterior chamber inflammation (ACI), synechiae, precipitates on the intraocular lens/cornea, visual acuity, and intraocular pressure. Results The intent-to-treat population comprised 105 patients (LE gel, n = 53; PA 1%, n = 52) including 52 patients aged 3 years or younger. Patients achieved a similar mean ACI grade on postoperative day 14 (primary efficacy endpoint) whether treated with LE gel 0.5% or PA 1% (difference = 0.006, 2-sided 95% CI, -0.281 to 0.292). Similar ACI outcomes additionally were observed in patients aged 3 years or younger. LE gel 0.5% and PA 1% also appeared equally effective in resolving inflammation at all visits (days 7, 14, and 28 postsurgery), based on categorical distributions of ACI, AC cells, and AC flare scores/grades (P ≥ .06). Synechiae and corneal/IOL precipitates occurred infrequently with no significant differences between groups. No safety or tolerability concerns were identified, including no treatment-related IOP increases. Conclusions LE gel 0.5% was safe and effective in treating pediatric postcataract surgical inflammation, with similar outcomes as PA 1%.
- Subjects :
- Intraocular pressure
medicine.medical_specialty
Visual acuity
medicine.medical_treatment
Prednisolone
Population
Intraocular lens
Cataract
03 medical and health sciences
0302 clinical medicine
Postoperative Complications
Double-Blind Method
Cornea
Medicine
Humans
education
Child
Intraocular Pressure
Inflammation
education.field_of_study
business.industry
Loteprednol Etabonate
Cataract surgery
Sensory Systems
Surgery
Androstadienes
Ophthalmology
Regimen
medicine.anatomical_structure
Tolerability
030221 ophthalmology & optometry
medicine.symptom
Ophthalmic Solutions
business
030217 neurology & neurosurgery
Subjects
Details
- ISSN :
- 18734502
- Volume :
- 46
- Issue :
- 8
- Database :
- OpenAIRE
- Journal :
- Journal of cataract and refractive surgery
- Accession number :
- edsair.doi.dedup.....8894253a25aef08c062e3fb9937da54e