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

NCT04623684 | Completed Phase 4

• 1 other identifier: 170/10-03-2020
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retinopathy of Prematurity

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Mydriatic efficacy: mm of pupil diameter (left and right eye)

  45 minutes after the first drop instillation

• Mydriatic efficacy: mm of pupil diameter (left and right eye)

  90 minutes after the first drop instillation

Secondary Outcomes (14)

• Mydriatic efficacy: mm of pupil diameter (left and right eye)

  120 minutes after the first drop instillation

• Systemic side effects: measurements of Heart Rate (bpm)

  45 minutes after the first drop instillation

• Systemic side effects: measurements of Heart Rate (bpm)

  90 minutes after the first drop instillation

• Systemic side effects: measurements of Heart Rate (bpm)

  120 minutes after the first drop instillation

• Systemic side effects: measurements of oxygen saturation (SpO2) (%)

  45 minutes after the first drop instillation

Study Arms (2)

Study Group

EXPERIMENTAL

Mydriasis with microdrops

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

Control Group

ACTIVE COMPARATOR

Mydriasis with standard drops

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

Interventions

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

1 drop (6-7 μL) for 3 doses, 5 minutes' intervals

Study Group

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

1 drop (28-34 μL) for 3 doses, 5 minutes' intervals

Control Group

Eligibility Criteria

• Age: 30 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

"Papageorgiou" General Hospital

Thessaloniki, 56429, Greece

Location

Related Publications (4)

• 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, Talimtzi P, Georgiou E, Diamanti E, Ziakas N, Haidich AB, Mataftsi A. Efficacy and safety of mydriatic microdrops for retinopathy of prematurity screening: an external pilot crossover randomized controlled trial. J Perinatol. 2022 Mar;42(3):371-377. doi: 10.1038/s41372-021-01229-w. Epub 2021 Oct 15.

  PMID: 34654903 RESULT

MeSH Terms

Conditions

Retinopathy of Prematurity; Mydriasis

Interventions

Phenylephrine; Tropicamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: October 31, 2020
• First Posted: November 10, 2020
• Study Start: March 24, 2020
• Primary Completion: September 22, 2020
• Study Completion: September 29, 2020
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)