Efficacy and Safety of Mydriatic Microdrops Compared With Standard Drops for Retinopathy of Prematurity (ROP) Screening: a Pilot Randomized Clinical Trial

PHASE4CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

March 24, 2020

Primary Completion Date

September 22, 2020

Study Completion Date

September 29, 2020

Conditions
Retinopathy of Prematurity
Interventions
DRUG

Microdrop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 6-7 μL)]

1 drop (6-7 μL) for 3 doses, 5 minutes' intervals

DRUG

Standard drop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 28-34 μL)]

1 drop (28-34 μL) for 3 doses, 5 minutes' intervals

Trial Locations (1)

56429

"Papageorgiou General Hospital", Thessaloniki

All Listed Sponsors
lead

Aristotle University Of Thessaloniki

OTHER

NCT04623684 - Efficacy and Safety of Mydriatic Microdrops Compared With Standard Drops for Retinopathy of Prematurity (ROP) Screening: a Pilot Randomized Clinical Trial | Biotech Hunter | Biotech Hunter