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

Sponsors

Lead Sponsor: Aristotle University Of Thessaloniki

Source

Aristotle University Of Thessaloniki

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.

Overall Status

Completed

Start Date

March 24, 2020

Completion Date

September 29, 2020

Primary Completion Date

September 22, 2020

Phase

Phase 4

Study Type

Interventional

Primary Outcome

Measure	Time Frame
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 Outcome

Measure	Time Frame
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
Systemic side effects: measurements of oxygen saturation (SpO2) (%)	90 minutes after the first drop instillation
Systemic side effects: measurements of oxygen saturation (SpO2) (%)	120 minutes after the first drop instillation
Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)	45 minutes after the first drop instillation
Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)	90 minutes after the first drop instillation
Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)	120 minutes after the first drop instillation
Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)	Hourly for the first 24 hours after mydriasis
Local side effects: periorbital pallor, eyelid swelling, flushing	45 minutes after the first drop instillation
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
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)

Enrollment

Condition

Retinopathy of Prematurity

Intervention

Intervention Type: Drug

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

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

Arm Group Label: Study Group

Intervention Type: Drug

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

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

Arm Group Label: Control Group

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

Gender: All

Minimum Age: 30 Weeks

Maximum Age: 37 Weeks

Healthy Volunteers: No

Location

Facility:

"Papageorpiou" General Hospital

Location Countries

Greece

Verification Date

November 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Aristotle University Of Thessaloniki

Investigator Full Name: Asimina Mataftsi

Investigator Title: Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus

Keywords

Has Expanded Access

Condition Browse

Number Of Arms

Arm Group

Label: Study Group

Type: Experimental

Description: Mydriasis with microdrops

Label: Control Group

Type: Active Comparator

Description: Mydriasis with standard drops

Patient Data

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Screening

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov