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

NCT ID: NCT04623684

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-24
• Study Completion Date: 2020-09-29

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.

Detailed Description

A pilot prospective randomized crossover clinical trial is conducted for assessing the mydriatic efficacy and safety of microdrops (6-7 μL) compared with standard drops (28-34 μL) for retinopathy of prematurity screening. A random number table was used to allocate participants into either a) receiving standard drop on their first and microdrop on their second screening examination a week later, or b) receiving microdrop first and standard drop a week later. The mydriatic agent contains phenylephrine 1.67% and tropicamide 0.33%, which derives from compounding the commercial phenylephrine 5% with the commercial tropicamide 0.5% in volume ratio 1:2.

Conditions

Retinopathy of Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: QUADRUPLE

Study Groups

Study Group

Mydriasis with microdrops

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Control Group

Mydriasis with standard drops

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

Asimina Mataftsi

Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

"Papageorgiou" General Hospital

Thessaloniki, , Greece

Countries

Greece

References

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.

Reference Type: BACKGROUND

PMID: 3662909 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9197568 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32772218 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34654903 (View on PubMed)

Other Identifiers

170/10-03-2020

Identifier Type: -

Identifier Source: org_study_id