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

Retinopathy of Prematurity 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04623684
• Other study ID #: 170/10-03-2020
• Status: Completed
• Phase: Phase 4
• Start date: March 24, 2020
• Est. completion date: September 29, 2020

Study information

• Verified date: March 2022
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 29, 2020
• Est. primary completion date: September 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Drug:
• Microdrop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 6-7 µL)]
1 drop (6-7 µL) for 3 doses, 5 minutes' intervals
• 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

Locations

Country	Name	City	State
Greece	"Papageorgiou" General Hospital	Thessaloníki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (4)

Elibol O, Alçelik T, Yüksel 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. — View 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. — View 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 Perinat — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mydriatic efficacy: mm of pupil diameter (left and right eye)		45 minutes after the first drop instillation
Primary	Mydriatic efficacy: mm of pupil diameter (left and right eye)		90 minutes after the first drop instillation
Secondary	Mydriatic efficacy: mm of pupil diameter (left and right eye)		120 minutes after the first drop instillation
Secondary	Systemic side effects: measurements of Heart Rate (bpm)		45 minutes after the first drop instillation
Secondary	Systemic side effects: measurements of Heart Rate (bpm)		90 minutes after the first drop instillation
Secondary	Systemic side effects: measurements of Heart Rate (bpm)		120 minutes after the first drop instillation
Secondary	Systemic side effects: measurements of oxygen saturation (SpO2) (%)		45 minutes after the first drop instillation
Secondary	Systemic side effects: measurements of oxygen saturation (SpO2) (%)		90 minutes after the first drop instillation
Secondary	Systemic side effects: measurements of oxygen saturation (SpO2) (%)		120 minutes after the first drop instillation
Secondary	Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)		45 minutes after the first drop instillation
Secondary	Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)		90 minutes after the first drop instillation
Secondary	Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)		120 minutes after the first drop instillation
Secondary	Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)		Hourly for the first 24 hours after mydriasis
Secondary	Local side effects: periorbital pallor, eyelid swelling, flushing		45 minutes after the first drop instillation
Secondary	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)		During the 24 hours after mydriasis for ROP screening
Secondary	Number of participants with non-adequate mydriasis to fully visualize peripheral fundus according to the examiner		Upon eye examination (45 to 90 minutes after the first drop)