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Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening (MyMiROPS)

Primary Purpose

Retinopathy of Prematurity

Status

Completed

Phase

Phase 4

Locations

Greece

Study Type

Interventional

Intervention

Microdrop administration of phenylephrine 1.67% and tropicamide 0.33%

Standard drop administration of phenylephrine 1.67% and tropicamide 0.33%

About this trial

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

Eligibility Criteria

30 Weeks - 36 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Preterm infants undergoing screening for ROP, i.e.

infants with GA < 32 weeks and/or BW < 1501 grams
infants of greater GA and BW with comorbidities, e.g. sepsis, prolonged need for oxygen supplementation etc., as recommended by the attending neonatologist

Exclusion Criteria:

Unstable clinical condition
Severe cardiovascular disease
Congenital anomalies
Clinical syndromes
Inotropes' intake during the week prior to enrollment
Traumatic apoptosis of the corneal epithelium
Corneal ulcer
Anatomical variations of the anterior segment
Infants that are outpatients at the commencement of ROP screening

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: millimeters of horizontal pupil diameter.

Secondary Outcome Measures

Mydriasis sustainability: millimeters of horizontal pupil diameter.

Pharmacokinetic profile of phenylephrine: area under the whole blood concentration versus time curve (AUC).

Each participant will be sampled once (random allocation to one time-point). Blood sampling will be combined with peripheral blood collection for routine examinations.

Pharmacokinetic profile of phenylephrine: maximum (peak) whole blood concentration (Cmax).

Each participant will be sampled once (random allocation to one time-point). Blood sampling will be combined with peripheral blood collection for routine examinations.

Pharmacokinetic profile of phenylephrine: time to reach maximum (peak) whole blood concentration (Tmax).

Each participant will be sampled once (random allocation to one time-point). Blood sampling will be combined with peripheral blood collection for routine examinations.

Pharmacokinetic profile of phenylephrine: elimination half-life (T1/2).

Each participant will be sampled once (random allocation to one time-point). Blood sampling will be combined with peripheral blood collection for routine examinations.

Heart rate values (beats per minute).

Oxygen saturation (SpO2) values (%).

Systolic, diastolic, and mean blood pressure values (mmHg).

Number of participants with systemic adverse events.

Apnea, increased gastric residuals, inhibited duodenal motor activity, delayed gastric emptying, feeding intolerance, abdominal distension, vomiting, paralytic ileus, acute gastric dilatation, necrotizing enterocolitis (NEC).

Number of participants with local adverse events.

Periorbital pallor, eyelid swelling, flushing.

Adequacy of judging the presence or absence of treatment-requiring ROP.

Full Information

NCT ID

NCT05043077

First Posted

September 2, 2021

Last Updated

February 9, 2023

Sponsor

Aristotle University Of Thessaloniki

Collaborators

National and Kapodistrian University of Athens

1. Study Identification

Unique Protocol Identification Number

NCT05043077

Brief Title

Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening

Acronym

MyMiROPS

Official Title

Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening: a Non-inferiority Crossover Randomized Controlled Trial (MyMiROPS Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

September 7, 2021 (Actual)

Primary Completion Date

January 20, 2023 (Actual)

Study Completion Date

January 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aristotle University Of Thessaloniki

Collaborators

National and Kapodistrian University of Athens

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 test the hypothesis that microdrop instillation of combined phenylephrine 1.67% and tropicamide 0.33% eyedrops causes at least equal mydriasis compared with standard drop instillation of the same mydriatic regimen, which constitutes routine care for pupil dilation during retinopathy of prematurity (ROP) screening in our neonatal intensive care unit. Comparison, also, will be made to the subsequent adverse events and the drug concentration in peripheral blood samples.

Detailed Description

A non-inferiority, crossover, randomized controlled trial will be conducted for this purpose. Participants will be randomly assigned to receive either a) microdrops on their first and standard drops on their second screening examination a week later (M/S group), or b) standard drops first and microdrops a week later (S/M group). Microdrops (6.5 μL) will be instilled using a calibrated micropipette, while standard drops (28-34 μL) will be instilled directly through the commercially available plastic multi-dose mydriatic dropper bottle.

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, phenylephrine, tropicamide, 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

83 (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 of phenylephrine 1.67% and tropicamide 0.33%

Intervention Description

1 drop (6.5 μL) for 3 doses with 5-minute intervals

Intervention Type

Drug

Intervention Name(s)

Standard drop administration of phenylephrine 1.67% and tropicamide 0.33%

Intervention Description

1 drop (28-34 μL) for 3 doses with 5-minute intervals

Primary Outcome Measure Information:

Title

Mydriatic efficacy: millimeters of horizontal pupil diameter.

Time Frame

45 minutes after the first drop instillation.

Secondary Outcome Measure Information:

Title

Mydriasis sustainability: millimeters of horizontal pupil diameter.

Time Frame

90 minutes after the first drop instillation.

Title

Mydriasis sustainability: millimeters of horizontal pupil diameter.

Time Frame

120 minutes after the first drop instillation.

Title

Pharmacokinetic profile of phenylephrine: area under the whole blood concentration versus time curve (AUC).

Description

Each participant will be sampled once (random allocation to one time-point). Blood sampling will be combined with peripheral blood collection for routine examinations.

Time Frame

Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.

Title

Pharmacokinetic profile of phenylephrine: maximum (peak) whole blood concentration (Cmax).

Description

Each participant will be sampled once (random allocation to one time-point). Blood sampling will be combined with peripheral blood collection for routine examinations.

Time Frame

Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.

Title

Pharmacokinetic profile of phenylephrine: time to reach maximum (peak) whole blood concentration (Tmax).

Description

Each participant will be sampled once (random allocation to one time-point). Blood sampling will be combined with peripheral blood collection for routine examinations.

Time Frame

Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.

Title

Pharmacokinetic profile of phenylephrine: elimination half-life (T1/2).

Description

Each participant will be sampled once (random allocation to one time-point). Blood sampling will be combined with peripheral blood collection for routine examinations.

Time Frame

Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.

Title

Heart rate values (beats per minute).

Time Frame

45, 90 and 120 minutes after the first drop instillation.

Title

Oxygen saturation (SpO2) values (%).

Time Frame

45, 90 and 120 minutes after the first drop instillation.

Title

Systolic, diastolic, and mean blood pressure values (mmHg).

Time Frame

45, 90 and 120 minutes after the first drop instillation. Hourly blood pressure measurements for the first 24 hours after mydriasis.

Title

Number of participants with systemic adverse events.

Description

Time Frame

During the 48 hours after mydriasis.

Title

Number of participants with local adverse events.

Description

Periorbital pallor, eyelid swelling, flushing.

Time Frame

45 minutes after the first drop instillation.

Title

Adequacy of judging the presence or absence of treatment-requiring ROP.

Time Frame

At the end of the eye examination (fundoscopy).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Weeks

Maximum Age & Unit of Time

36 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Preterm infants undergoing screening for ROP, i.e. infants with GA < 32 weeks and/or BW < 1501 grams infants of greater GA and BW with comorbidities, e.g. sepsis, prolonged need for oxygen supplementation etc., as recommended by the attending neonatologist Exclusion Criteria: Unstable clinical condition Severe cardiovascular disease Congenital anomalies Clinical syndromes Inotropes' intake during the week prior to enrollment Traumatic apoptosis of the corneal epithelium Corneal ulcer Anatomical variations of the anterior segment Infants that are outpatients at the commencement of ROP screening

Facility Information:

Facility Name

Papageorgiou General Hospital

City

Thessaloníki

ZIP/Postal Code

56429

Country

Greece

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Deidentified Individual Participant Data (IPD) that underline published results, along with related data dictionaries, will be available from 3 months to 36 months following article publication, only to researchers who will provide a methodologically sound proposal, for types of analyses to achieve aims in the approved proposal or for individual participant data meta-analysis, and only after acceptance of the proposed protocol by our Institution's IRB. Proposals should be directed to the corresponding author (AM, amatafts@auth.gr) and data requestors will need to sign a data access agreement. The study protocol and statistical analysis plan will also be available, if needed.

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

35428316

Citation

Seliniotaki AK, Haidich AB, Lithoxopoulou M, Gika H, Boutou E, Virgiliou C, Nikolaidou M, Dokoumetzidis A, Raikos N, Diamanti E, Ziakas N, Mataftsi A. Efficacy and safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening (MyMiROPS): study protocol for a non-inferiority crossover randomized controlled trial. Trials. 2022 Apr 15;23(1):322. doi: 10.1186/s13063-022-06243-7.

Results Reference

derived

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Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening

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