Conditions: Unilateral Cataract Extraction Congenital Cataract
Keywords: Cataract Lens replacement pediatric
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 78
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when administered in irrigation solution during cataract extraction on intraoperative pupil diameter, acute postoperative pain, and safety in children birth through 3 years.

Detailed description:
This study is a randomized, parallel-group, double-masked, phenylephrine-controlled study of OMS302 in young children ages birth through three years undergoing unilateral cataract extraction with or without lens replacement. Administration of test irrigation solutions will take place in a double-masked fashion.

Intraoperative pupil size will be determined by measurement of pupil diameter from still photos captured from video recordings of the procedure. Pupil diameter measurements will be performed immediately prior to the initial incision and at one-minute intervals until the end of the procedure (wound closure). Pain will be assessed by the Alder Hey Triage Pain Score.

Arms:
arm 1: OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution arm 2: Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution

Interventions: intervention 1: OMS302 intervention 2: Phenylephrine HCl
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: