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

March 23, 2022 updated by: Asimina Mataftsi, Aristotle University Of Thessaloniki
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloníki, Greece, 56429
        • "Papageorgiou" General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 8 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study Group
Mydriasis with microdrops
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
ACTIVE_COMPARATOR: Control Group
Mydriasis with standard drops
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mydriatic efficacy: mm of pupil diameter (left and right eye)
Time Frame: 45 minutes after the first drop instillation
45 minutes after the first drop instillation
Mydriatic efficacy: mm of pupil diameter (left and right eye)
Time Frame: 90 minutes after the first drop instillation
90 minutes after the first drop instillation

Secondary Outcome Measures

Outcome Measure
Time Frame
Mydriatic efficacy: mm of pupil diameter (left and right eye)
Time Frame: 120 minutes after the first drop instillation
120 minutes after the first drop instillation
Systemic side effects: measurements of Heart Rate (bpm)
Time Frame: 45 minutes after the first drop instillation
45 minutes after the first drop instillation
Systemic side effects: measurements of Heart Rate (bpm)
Time Frame: 90 minutes after the first drop instillation
90 minutes after the first drop instillation
Systemic side effects: measurements of Heart Rate (bpm)
Time Frame: 120 minutes after the first drop instillation
120 minutes after the first drop instillation
Systemic side effects: measurements of oxygen saturation (SpO2) (%)
Time Frame: 45 minutes after the first drop instillation
45 minutes after the first drop instillation
Systemic side effects: measurements of oxygen saturation (SpO2) (%)
Time Frame: 90 minutes after the first drop instillation
90 minutes after the first drop instillation
Systemic side effects: measurements of oxygen saturation (SpO2) (%)
Time Frame: 120 minutes after the first drop instillation
120 minutes after the first drop instillation
Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)
Time Frame: 45 minutes after the first drop instillation
45 minutes after the first drop instillation
Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)
Time Frame: 90 minutes after the first drop instillation
90 minutes after the first drop instillation
Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)
Time Frame: 120 minutes after the first drop instillation
120 minutes after the first drop instillation
Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)
Time Frame: Hourly for the first 24 hours after mydriasis
Hourly for the first 24 hours after mydriasis
Local side effects: periorbital pallor, eyelid swelling, flushing
Time Frame: 45 minutes after the first drop instillation
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)
Time Frame: During the 24 hours after mydriasis for ROP screening
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
Time Frame: Upon eye examination (45 to 90 minutes after the first drop)
Upon eye examination (45 to 90 minutes after the first drop)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 24, 2020

Primary Completion (ACTUAL)

September 22, 2020

Study Completion (ACTUAL)

September 29, 2020

Study Registration Dates

First Submitted

October 31, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (ACTUAL)

November 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 170/10-03-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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