Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening

NCT05043077 | Completed Phase 4

• 1 other identifier: 23265/14-07-2021
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retinopathy of Prematurity

Keywords

microdrops; mydriasis; dilating drops; phenylephrine; tropicamide; retinopathy of prematurity; ROP; screening

Outcome Measures

Primary Outcomes (1)

• Mydriatic efficacy: millimeters of horizontal pupil diameter.

  45 minutes after the first drop instillation.

Secondary Outcomes (12)

• Mydriasis sustainability: millimeters of horizontal pupil diameter.

  90 minutes after the first drop instillation.

• Mydriasis sustainability: millimeters of horizontal pupil diameter.

  120 minutes after the first drop instillation.

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

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

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

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

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

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

Study Arms (2)

Study Group

EXPERIMENTAL

Mydriasis with microdrops

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

Control Group

ACTIVE COMPARATOR

Mydriasis with standard drops

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

Interventions

Microdrop administration of phenylephrine 1.67% and tropicamide 0.33% DRUG

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

Study Group

Standard drop administration of phenylephrine 1.67% and tropicamide 0.33% DRUG

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

Control Group

Eligibility Criteria

• Age: 30 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

Papageorgiou General Hospital

Thessaloniki, 56429, Greece

Location

Related Publications (5)

• Lynch MG, Brown RH, Goode SM, Schoenwald RD, Chien DS. Reduction of phenylephrine drop size in infants achieves equal dilation with decreased systemic absorption. Arch Ophthalmol. 1987 Oct;105(10):1364-5. doi: 10.1001/archopht.1987.01060100066027.

  PMID: 3662909 BACKGROUND

• Elibol O, Alcelik T, Yuksel N, Caglar Y. The influence of drop size of cyclopentolate, phenylephrine and tropicamide on pupil dilatation and systemic side effects in infants. Acta Ophthalmol Scand. 1997 Apr;75(2):178-80. doi: 10.1111/j.1600-0420.1997.tb00119.x.

  PMID: 9197568 BACKGROUND

• Seliniotaki AK, Prousali E, Lithoxopoulou M, Kokkali S, Ziakas N, Soubasi V, Mataftsi A. Alternative mydriasis techniques for retinopathy of prematurity screening. Int Ophthalmol. 2020 Dec;40(12):3613-3619. doi: 10.1007/s10792-020-01542-x. Epub 2020 Aug 9.

  PMID: 32772218 BACKGROUND

• Seliniotaki AK, Lithoxopoulou M, Virgiliou C, Gika H, Dokoumetzidis A, Bougioukas KI, Raikos N, Diamanti E, Ziakas N, Haidich AB, Mataftsi A. Efficacy and Safety of Mydriatic Microdrops for Retinopathy of Prematurity Screening: The MyMiROPS Randomized Clinical Trial. JAMA Ophthalmol. 2025 Feb 1;143(2):110-116. doi: 10.1001/jamaophthalmol.2024.5462.

  PMID: 39724200 RESULT

• Seliniotaki AK, Haidich AB, Lithoxopoulou M, Gika H, Boutou E, Virgiliou C, Nikolaidou M, Dokoumetzidis A, Raikos N, Diamanti E, Ziakas N, Mataftsi A. Efficacy and safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening (MyMiROPS): study protocol for a non-inferiority crossover randomized controlled trial. Trials. 2022 Apr 15;23(1):322. doi: 10.1186/s13063-022-06243-7.

  PMID: 35428316 DERIVED

MeSH Terms

Conditions

Retinopathy of Prematurity; Mydriasis

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pupil Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 13, 2021
• Study Start: September 7, 2021
• Primary Completion: January 20, 2023
• Study Completion: January 23, 2023
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)