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Retinopathy of PrematurityPhase 4NCT04623684

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

A Phase 4 study testing Microdrop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 6-7 μL)] and Standard drop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 28-34 μL)] in people with Retinopathy of Prematurity, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 37 weeks
Conditions the study is for
Retinopathy of Prematurity
What is being tested?
Microdrop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 6-7 μL)] and Standard drop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 28-34 μL)]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteGreece
Study dates
24 Mar 2020to 29 Sep 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 37 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • "Papageorgiou" General Hospital

    Thessaloniki, 56429

Other trials in Greece

About this study

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.

Read the 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.

Being tested
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)]
Keywords
microdrops, mydriasis, dilating drops, retinopathy of prematurity, ROP, screening
Medical subject headings
Retinopathy of Prematurity, Mydriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

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

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

Study groups in NCT04623684
Study groupRoleWhat they receive
Study GroupExperimentalMydriasis with microdrops
Receives: Drug: Microdrop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 6-7 μL)]
Control GroupActive comparatorMydriasis with standard drops
Receives: Drug: Standard drop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 28-34 μL)]

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 45 minutes after the first drop instillation

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

    Measured: 90 minutes after the first drop instillation

Secondary outcomes (14)

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

    Measured: 120 minutes after the first drop instillation

  2. Systemic side effects: measurements of Heart Rate (bpm)

    Measured: 45 minutes after the first drop instillation

  3. Systemic side effects: measurements of Heart Rate (bpm)

    Measured: 90 minutes after the first drop instillation

  4. Systemic side effects: measurements of Heart Rate (bpm)

    Measured: 120 minutes after the first drop instillation

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

    Measured: 45 minutes after the first drop instillation

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

    Measured: 90 minutes after the first drop instillation

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

    Measured: 120 minutes after the first drop instillation

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

    Measured: 45 minutes after the first drop instillation

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

    Measured: 90 minutes after the first drop instillation

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

    Measured: 120 minutes after the first drop instillation

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

    Measured: Hourly for the first 24 hours after mydriasis

  12. Local side effects: periorbital pallor, eyelid swelling, flushing

    Measured: 45 minutes after the first drop instillation

  13. 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)

    Measured: During the 24 hours after mydriasis for ROP screening

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

    Measured: Upon eye examination (45 to 90 minutes after the first drop)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2020
  2. Study start24 Mar 2020
  3. Primary completion22 Sep 2020
  4. Study completion29 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Screening
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04623684
Sponsor's protocol ID
170/10-03-2020
Status last verified
Mar 2022
First submitted
31 Oct 2020
Last updated
4 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 3662909

  • 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.

    PubMed 9197568

  • 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.

    PubMed 32772218

  • 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.

    PubMed 34654903

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Microdrop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 6-7 μL)] and Standard drop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 28-34 μL)] in people with Retinopathy of Prematurity, run by Aristotle University Of Thessaloniki at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mydriatic efficacy: mm of pupil diameter (left and right eye) (time frame: 45 minutes after the first drop instillation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04623684, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.

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