Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-07

Study Completion Date

2023-01-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Retinopathy of Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Study Group

Mydriasis with microdrops

Group Type EXPERIMENTAL

Microdrop administration of phenylephrine 1.67% and tropicamide 0.33%

Intervention Type DRUG

1 drop (6.5 μL) for 3 doses with 5-minute intervals

Control Group

Mydriasis with standard drops

Group Type ACTIVE_COMPARATOR

Standard drop administration of phenylephrine 1.67% and tropicamide 0.33%

Intervention Type DRUG

1 drop (28-34 μL) for 3 doses with 5-minute intervals

Interventions

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Microdrop administration of phenylephrine 1.67% and tropicamide 0.33%

1 drop (6.5 μL) for 3 doses with 5-minute intervals

Intervention Type DRUG

Standard drop administration of phenylephrine 1.67% and tropicamide 0.33%

1 drop (28-34 μL) for 3 doses with 5-minute intervals

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No