Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening (MyMiROPS)

Aristotle University Of Thessaloniki

Status and phase: Completed; Phase 4

Conditions: Retinopathy of Prematurity

Treatments: Drug: Microdrop administration of phenylephrine 1.67% and tropicamide 0.33%; Drug: Standard drop administration of phenylephrine 1.67% and tropicamide 0.33%

Study type: Interventional

Funder types: Other

Identifiers

NCT05043077

23265/14-07-2021

Details and patient eligibility

About

The purpose is to test the hypothesis that microdrop instillation of combined phenylephrine 1.67% and tropicamide 0.33% eyedrops causes at least equal mydriasis compared with standard drop instillation of the same mydriatic regimen, which constitutes routine care for pupil dilation during retinopathy of prematurity (ROP) screening in our neonatal intensive care unit. Comparison, also, will be made to the subsequent adverse events and the drug concentration in peripheral blood samples.

Full description

A non-inferiority, crossover, randomized controlled trial will be conducted for this purpose. Participants will be randomly assigned to receive either a) microdrops on their first and standard drops on their second screening examination a week later (M/S group), or b) standard drops first and microdrops a week later (S/M group). Microdrops (6.5 μL) will be instilled using a calibrated micropipette, while standard drops (28-34 μL) will be instilled directly through the commercially available plastic multi-dose mydriatic dropper bottle.

Enrollment: 83 patients

Sex: All

Ages: 30 to 36 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

Preterm infants undergoing screening for ROP, i.e.

• infants with GA < 32 weeks and/or BW < 1501 grams
• infants of greater GA and BW with comorbidities, e.g. sepsis, prolonged need for oxygen supplementation etc., as recommended by the attending neonatologist

Exclusion criteria

• Unstable clinical condition
• Severe cardiovascular disease
• Congenital anomalies
• Clinical syndromes
• Inotropes' intake during the week prior to enrollment
• Traumatic apoptosis of the corneal epithelium
• Corneal ulcer
• Anatomical variations of the anterior segment
• Infants that are outpatients at the commencement of ROP screening

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

83 participants in 2 patient groups

Study Group

Experimental group

Description:

Mydriasis with microdrops

Treatment:

Drug: Microdrop administration of phenylephrine 1.67% and tropicamide 0.33%

Control Group

Active Comparator group

Description:

Mydriasis with standard drops

Treatment:

Drug: Standard drop administration of phenylephrine 1.67% and tropicamide 0.33%