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

Primary Purpose

Retinopathy of Prematurity

Status

Completed

Phase

Phase 4

Locations

Greece

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional screening trial for Retinopathy of Prematurity focused on measuring microdrops, mydriasis, dilating drops, retinopathy of prematurity, ROP, screening

Eligibility Criteria

30 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

"Papageorgiou" General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Group

Control Group

Arm Description

Mydriasis with microdrops

Mydriasis with standard drops

Outcomes

Primary Outcome Measures

Mydriatic efficacy: mm of pupil diameter (left and right eye)

Secondary Outcome Measures

Mydriatic efficacy: mm of pupil diameter (left and right eye)

Systemic side effects: measurements of Heart Rate (bpm)

Systemic side effects: measurements of oxygen saturation (SpO2) (%)

Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)

Local side effects: periorbital pallor, eyelid swelling, flushing

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)

Number of participants with non-adequate mydriasis to fully visualize peripheral fundus according to the examiner

Full Information

NCT ID

NCT04623684

First Posted

October 31, 2020

Last Updated

March 23, 2022

Sponsor

Aristotle University Of Thessaloniki

1. Study Identification

Unique Protocol Identification Number

NCT04623684

Brief Title

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

March 24, 2020 (Actual)

Primary Completion Date

September 22, 2020 (Actual)

Study Completion Date

September 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aristotle University Of Thessaloniki

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinopathy of Prematurity

Keywords

microdrops, mydriasis, dilating drops, retinopathy of prematurity, ROP, screening

7. Study Design

Primary Purpose

Screening

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Group

Arm Type

Experimental

Arm Description

Mydriasis with microdrops

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Mydriasis with standard drops

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Mydriatic efficacy: mm of pupil diameter (left and right eye)

Time Frame

45 minutes after the first drop instillation

Title

Mydriatic efficacy: mm of pupil diameter (left and right eye)

Time Frame

90 minutes after the first drop instillation

Secondary Outcome Measure Information:

Title

Mydriatic efficacy: mm of pupil diameter (left and right eye)

Time Frame

120 minutes after the first drop instillation

Title

Systemic side effects: measurements of Heart Rate (bpm)

Time Frame

45 minutes after the first drop instillation

Title

Systemic side effects: measurements of Heart Rate (bpm)

Time Frame

90 minutes after the first drop instillation

Title

Systemic side effects: measurements of Heart Rate (bpm)

Time Frame

120 minutes after the first drop instillation

Title

Systemic side effects: measurements of oxygen saturation (SpO2) (%)

Time Frame

45 minutes after the first drop instillation

Title

Systemic side effects: measurements of oxygen saturation (SpO2) (%)

Time Frame

90 minutes after the first drop instillation

Title

Systemic side effects: measurements of oxygen saturation (SpO2) (%)

Time Frame

120 minutes after the first drop instillation

Title

Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)

Time Frame

45 minutes after the first drop instillation

Title

Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)

Time Frame

90 minutes after the first drop instillation

Title

Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)

Time Frame

120 minutes after the first drop instillation

Title

Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)

Time Frame

Hourly for the first 24 hours after mydriasis

Title

Local side effects: periorbital pallor, eyelid swelling, flushing

Time Frame

45 minutes after the first drop instillation

Title

Time Frame

During the 24 hours after mydriasis for ROP screening

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Weeks

Maximum Age & Unit of Time

37 Weeks

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

"Papageorgiou" General Hospital

City

Thessaloníki

ZIP/Postal Code

56429

Country

Greece

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

3662909

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.

Results Reference

background

PubMed Identifier

9197568

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.

Results Reference

background

PubMed Identifier

32772218

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.

Results Reference

background

PubMed Identifier

34654903

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.

Results Reference

result

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

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