Evidence map›Paper›PMID 35428316›Full record

ArticleTrials2022

Efficacy and safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening (MyMiROPS): study protocol for a non-inferiority crossover randomized controlled trial.

Aikaterini K Seliniotaki, Anna-Bettina Haidich, Maria Lithoxopoulou, Helen Gika, Eleftheria Boutou, Christina Virgiliou, Martha Nikolaidou, Aristides Dokoumetzidis, Nikolaos Raikos, Elisavet Diamanti and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05043077 (Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 41% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05043077 phase4completednot on this map

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

TypeinterventionalSponsorAristotle University Of ThessalonikiRan2021 to 2023Enrolled83ConditionsRetinopathy of PrematurityArmsMicrodrop administration of phenylephrine 1.67% and tropicamide 0.33%, Standard drop administration of phenylephrine 1.67% and tropicamide 0.33%
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 1 country.

Aikaterini K Seliniotaki2nd Department of Ophthalmology, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Papageorgiou General Hospital, N.Efkarpia, 56429, Thessaloniki, Greece.
Anna-Bettina HaidichDepartment of Hygiene, Social-Preventive Medicine & Medical Statistics, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Maria Lithoxopoulou2nd Department of Neonatology, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Helen GikaSchool of Medicine, Laboratory of forensic medicine & toxicology, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Eleftheria BoutouDepartment of Chemistry, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Christina VirgiliouDepartment of Chemistry, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Martha NikolaidouClinical Research Manager, Elpen Pharmaceutical Co.Inc., Athens, Greece.
Aristides DokoumetzidisDepartment of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.
Nikolaos RaikosSchool of Medicine, Laboratory of forensic medicine & toxicology, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Elisavet Diamanti2nd Department of Neonatology, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Nikolaos Ziakas2nd Department of Ophthalmology, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Papageorgiou General Hospital, N.Efkarpia, 56429, Thessaloniki, Greece.
Asimina Mataftsi2nd Department of Ophthalmology, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Papageorgiou General Hospital, N.Efkarpia, 56429, Thessaloniki, Greece. amatafts@auth.gr.ORCID http://orcid.org/0000-0002-4238-022X
Aristotle University of Thessaloniki · GRElpen Pharmaceutical (Greece) · GRNational and Kapodistrian University of Athens · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRetinopathy of prematurity (ROP) eye examination screening presupposes adequate mydriasis for an informative fundoscopy of preterm infants at risk, on a weekly basis. Systemic absorption of the instilled mydriatic regimens has been associated with various adverse events in this fragile population. This report aims to present the fully developed protocol of a full-scale trial for testing the hypothesis that the reduced mydriatic drop volume achieves adequate mydriasis while minimizing systemic adverse events.

methodsA non-inferiority crossover randomized controlled trial will be performed to study the efficacy and safety of combined phenylephrine 1.67% and tropicamide 0.33% microdrops compared with standard drops in a total of 93 preterm infants requiring ROP screening. Primary outcome will be the pupil diameter at 45 (T45) min after instillation. Pupil diameter at T90 and T120 will constitute secondary efficacy endpoints. Mixed-effects linear regression models will be developed, and the 95% confidence interval approach will be used for assessing non-inferiority. Whole blood samples will be analyzed using hydrophilic liquid chromatography-tandem mass spectrometry method (HILIC-MS/MS), for gathering pharmacokinetic (PK) data on the instilled phenylephrine, at nine specific time points within 3 h from mydriasis. Pooled PK data will be used due to ethical restrictions on having a full PK profile per infant. Heart rate, oxygen saturation, blood pressure measurements, and 48-h adverse events will also be recorded. DISCUSSION: This protocol is designed for a study powered to assess non-inferiority of microdrops compared with standard dilating drops. If our hypothesis is confirmed, microdrops may become a useful tool in ROP screening.

trial registrationClinicalTrials.gov NCT05043077 . Registered on 2 September 2021.

Indexed as

MydriaticsOphthalmic SolutionsRetinopathy of PrematurityEquivalence Trials as TopicHeart RateHumansInfant, NewbornInfant, PrematureMydriasisPhenylephrineRandomized Controlled Trials as TopicTandem Mass SpectrometryMydriaticsOphthalmic SolutionsPhenylephrineMydriasisPhenylephrinePreterm infantsPupil dilationTropicamide

Identifiers

PMID35428316
PMCPMC9013111
OpenAlexW4223917545

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.