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

Aristotle University Of Thessaloniki

Status and phase: Completed; Phase 4

Conditions: Retinopathy of Prematurity

Treatments: Drug: Microdrop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 6-7 μL)]; Drug: Standard drop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 28-34 μL)]

Study type: Interventional

Funder types: Other

Identifiers

NCT04623684

170/10-03-2020

Details and patient eligibility

About

The purpose is to assess whether the use of microdrop instillation of phenylephrine 1.67% and tropicamide 0.33% maintains mydriatic efficacy while presents an improved safety profile compared with standard drops of phenylephrine 1.67% and tropicamide 0.33%, which is routine care for pupil dilation during retinopathy of prematurity (ROP) screening in our neonatal intensive care unit.

Full description

A pilot prospective randomized crossover clinical trial is conducted for assessing the mydriatic efficacy and safety of microdrops (6-7 μL) compared with standard drops (28-34 μL) for retinopathy of prematurity screening. A random number table was used to allocate participants into either a) receiving standard drop on their first and microdrop on their second screening examination a week later, or b) receiving microdrop first and standard drop a week later. The mydriatic agent contains phenylephrine 1.67% and tropicamide 0.33%, which derives from compounding the commercial phenylephrine 5% with the commercial tropicamide 0.5% in volume ratio 1:2.

Enrollment: 25 patients

Sex: All

Ages: 30 to 37 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

Preterm infants undergoing screening for ROP, i.e.

• with gestational age (GA) < 32 weeks and/or birth weight (BW) < 1501 grams
• infants of greater GA and BW with increased comorbidity, e.g. sepsis, prolonged need for oxygen supplementation etc.

Exclusion criteria

• Unstable clinical condition
• Suspicion of cardiovascular disease
• Severe congenital anomalies
• Clinical syndromes
• Traumatic apoptosis of the corneal epithelium
• Corneal ulcer
• Anatomical variations of the anterior segment

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups

Study Group

Experimental group

Description:

Mydriasis with microdrops

Treatment:

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

Control Group

Active Comparator group

Description:

Mydriasis with standard drops

Treatment:

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