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NCT Number: NCT05043077

Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening

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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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Mydriasis Pupil Disorders Retinal Diseases

Age range

30 week–36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Papageorgiou General Hospital

Thessaloniki, 56429, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microdrop administration of phenylephrine 1.67% and tropicamide 0.33%

Drug

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

Standard drop administration of phenylephrine 1.67% and tropicamide 0.33%

Drug

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

Primary outcomes

  1. Mydriatic efficacy: millimeters of horizontal pupil diameter.

    Time frame: 45 minutes after the first drop instillation.

Secondary outcomes

  1. Mydriasis sustainability: millimeters of horizontal pupil diameter.

    Time frame: 90 minutes after the first drop instillation.

  2. Mydriasis sustainability: millimeters of horizontal pupil diameter.

    Time frame: 120 minutes after the first drop instillation.

  3. Pharmacokinetic profile of phenylephrine: area under the whole blood concentration versus time curve (AUC).

    Time frame: Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.

    Each participant will be sampled once (random allocation to one time-point). Blood sampling will be combined with peripheral blood collection for routine examinations.

  4. Pharmacokinetic profile of phenylephrine: maximum (peak) whole blood concentration (Cmax).

    Time frame: Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.

    Each participant will be sampled once (random allocation to one time-point). Blood sampling will be combined with peripheral blood collection for routine examinations.

  5. Pharmacokinetic profile of phenylephrine: time to reach maximum (peak) whole blood concentration (Tmax).

    Time frame: Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.

    Each participant will be sampled once (random allocation to one time-point). Blood sampling will be combined with peripheral blood collection for routine examinations.

  6. Pharmacokinetic profile of phenylephrine: elimination half-life (T1/2).

    Time frame: Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.

    Each participant will be sampled once (random allocation to one time-point). Blood sampling will be combined with peripheral blood collection for routine examinations.

  7. Heart rate values (beats per minute).

    Time frame: 45, 90 and 120 minutes after the first drop instillation.

  8. Oxygen saturation (SpO2) values (%).

    Time frame: 45, 90 and 120 minutes after the first drop instillation.

  9. Systolic, diastolic, and mean blood pressure values (mmHg).

    Time frame: 45, 90 and 120 minutes after the first drop instillation. Hourly blood pressure measurements for the first 24 hours after mydriasis.

  10. Number of participants with systemic adverse events.

    Time frame: During the 48 hours after mydriasis.

    Apnea, increased gastric residuals, inhibited duodenal motor activity, delayed gastric emptying, feeding intolerance, abdominal distension, vomiting, paralytic ileus, acute gastric dilatation, necrotizing enterocolitis (NEC).

  11. Number of participants with local adverse events.

    Time frame: 45 minutes after the first drop instillation.

    Periorbital pallor, eyelid swelling, flushing.

  12. Adequacy of judging the presence or absence of treatment-requiring ROP.

    Time frame: At the end of the eye examination (fundoscopy).

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • National and Kapodistrian University of Athens

Registry information

Official study title

Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening: a Non-inferiority Crossover Randomized Controlled Trial (MyMiROPS Trial)

Acronym: MyMiROPS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2021
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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