This study is designed to assess how KPI-121 1% compares to prednisolone acetate in reducing inflammation after cataract surgery in young children. Approximately half the participants will receive KPI-121 1% eye drops and the other half will receive prednisolone acetate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2
eye drops
eye drops
Byers Eye Institute at Stanford University
Palo Alto, California, United States
Children's Eye Care, PC
Detroit, Michigan, United States
Pediatric Ophthalmology of Erie, Inc.
Erie, Pennsylvania, United States
Houston Eye Associates
The Woodlands, Texas, United States
Anterior Chamber Cell Grade
Anterior chamber cell grading is a way of quantifying the amount of inflammation in inflammatory eye processes. Higher values indicate greater inflammation. The anterior chamber cell grading uses whole numbers from 0 (no cells) to 4 (\> 30 cells) as follows: Anterior chamber cell grade 0 = no cells seen Anterior chamber cell grade 1 = 1 - 5 cells Anterior chamber cell grade 2 = 6 - 15 cells Anterior chamber cell grade 4 = greater than 30 cells
Time frame: Day 15
Modified Global Overall Assessment of Postoperative Inflammation
The Modified Global Overall Assessment is a way of quantifying the amount of post operative healing that has occurred. Lower values indicate greater healing.The Modified Global Assessment grading uses whole numbers from 0 (clear) to 2 (not improving or worsening) as follows: 0 = clear 1. = improving satisfactorily 2. = not improving or worsening
Time frame: Day 15
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