Clinical trial NCT04623684: Efficacy and Safety of Mydriatic Microdrops Compared With Standard Drops for Retinopathy of Prematurity (ROP) Screening: a Pilot Randomized Clinical Trial
Official title: Efficacy and Safety of Mydriatic Microdrops Compared With Standard Drops for Retinopathy of Prematurity (ROP) Screening: a Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Retinopathy of Prematurity
Keywords: microdrops
mydriasis
dilating drops
retinopathy of prematurity
ROP
screening
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Mydriatic efficacy: mm of pupil diameter (left and right eye)
timeFrame: 45 minutes after the first drop instillation
measure: Mydriatic efficacy: mm of pupil diameter (left and right eye)
timeFrame: 90 minutes after the first drop instillation
Secondary outcomes:
measure: Mydriatic efficacy: mm of pupil diameter (left and right eye)
timeFrame: 120 minutes after the first drop instillation
measure: Systemic side effects: measurements of Heart Rate (bpm)
timeFrame: 45 minutes after the first drop instillation
measure: Systemic side effects: measurements of Heart Rate (bpm)
timeFrame: 90 minutes after the first drop instillation
measure: Systemic side effects: measurements of Heart Rate (bpm)
timeFrame: 120 minutes after the first drop instillation
measure: Systemic side effects: measurements of oxygen saturation (SpO2) (%)
timeFrame: 45 minutes after the first drop instillation
measure: Systemic side effects: measurements of oxygen saturation (SpO2) (%)
timeFrame: 90 minutes after the first drop instillation
measure: Systemic side effects: measurements of oxygen saturation (SpO2) (%)
timeFrame: 120 minutes after the first drop instillation
measure: Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)
timeFrame: 45 minutes after the first drop instillation
measure: Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)
timeFrame: 90 minutes after the first drop instillation
measure: Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)
timeFrame: 120 minutes after the first drop instillation
measure: Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)
timeFrame: Hourly for the first 24 hours after mydriasis
measure: Local side effects: periorbital pallor, eyelid swelling, flushing
timeFrame: 45 minutes after the first drop instillation
measure: Adverse events including apnea, increased gastric residuals, inhibited duodenal motor activity, delayed gastric emptying, feeding intolerance, abdominal distension, vomiting, paralytic ileus, acute gastric dilatation and necrotizing enterocolitis (NEC)
timeFrame: During the 24 hours after mydriasis for ROP screening
measure: Number of participants with non-adequate mydriasis to fully visualize peripheral fundus according to the examiner
timeFrame: Upon eye examination (45 to 90 minutes after the first drop)
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: "Papageorgiou" General Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.