Evidence map›Paper›PMID 34654903›Full record

Trial reportJournal of perinatology : official journal of the California Perinatal Association2022

Efficacy and safety of mydriatic microdrops for retinopathy of prematurity screening: an external pilot crossover randomized controlled trial.

Aikaterini K Seliniotaki, Maria Lithoxopoulou, Persefoni Talimtzi, Elisavet Georgiou, Elisavet Diamanti, Nikolaos Ziakas, Anna-Bettina Haidich, Asimina Mataftsi

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04623684 (Efficacy and Safety of Mydriatic Microdrops Compared With Standard Drops for Retinopathy of Prematurity), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

NCT04623684 phase4completednot on this map

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

TypeinterventionalSponsorAristotle University Of ThessalonikiRan2020 to 2020Enrolled25ConditionsRetinopathy of PrematurityArmsMicrodrop 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)]
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Optimizing instilled drug delivery: a scoping review of microdrops in ophthalmology.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
    Article
  4. Article
  5. 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

8 authors.

Aikaterini K Seliniotaki2nd Department of Ophthalmology, 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.
Persefoni TalimtziDepartment of Hygiene, Social-Preventive Medicine & Medical Statistics, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Elisavet GeorgiouLaboratory of Biological Chemistry, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.ORCID http://orcid.org/0000-0001-8732-0610
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, 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.
Asimina Mataftsi2nd Department of Ophthalmology, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece. amatafts@auth.gr.ORCID http://orcid.org/0000-0002-4238-022X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo study the efficacy and safety of mydriatic microdrops compared with standard drops for retinopathy of prematurity (ROP) screening. STUDY

designPreterm infants undergoing ROP screening received microdrops and standard drops of phenylephrine 1.67% and tropicamide 0.33% in a random allocation sequence at two consecutive weekly examinations. Primary outcome was pupil diameter measured by two masked observers at 45 (T45) and 90 (T90) minutes after instillation.

resultsTwenty-five infants were randomized. No differences observed in mean pupil diameter after either administration technique at all time points (T45 Mean Difference: -0.14; 95% Confidence Interval: -0.38, 0.09; p = 0.23). Heart rate values at T120 were lower after microdrop instillation (p = 0.046). Otherwise, adverse events did not differ after either administration technique.

conclusionThis pilot study provides evidence of microdrops mydriasis efficacy, while justifying a full-scale trial to confirm their non-inferiority compared with standard drops and provide more data about safety.

trial registrationClinicalTrials.gov: NCT04623684.

Indexed as

MydriaticsRetinopathy of PrematurityHeart RateHumansInfantInfant, NewbornInfant, PrematureOphthalmic SolutionsPhenylephrinePilot ProjectsTropicamideMydriaticsOphthalmic SolutionsPhenylephrineTropicamide

Identifiers

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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.