Retinopathy of PrematurityPhase 4MyMiROPSNCT05043077
Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening
A Phase 4 study testing Microdrop administration of phenylephrine 1.67% and tropicamide 0.33% and Standard drop administration of phenylephrine 1.67% and tropicamide 0.33% in people with Retinopathy of Prematurity, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 36 weeks
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Microdrop administration of phenylephrine 1.67% and tropicamide 0.33% and Standard drop administration of phenylephrine 1.67% and tropicamide 0.33%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteGreece
- Study dates
- 7 Sep 2021to 23 Jan 2023
- 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 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Unstable clinical condition
- Severe cardiovascular disease
- Congenital anomalies
- Clinical syndromes
- Inotropes' intake during the week prior to enrollment
- Traumatic apoptosis of the corneal epithelium
Show all 9Show fewer
- Corneal ulcer
- Anatomical variations of the anterior segment
- Infants that are outpatients at the commencement of ROP screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening: a Non-inferiority Crossover Randomized Controlled Trial (MyMiROPS Trial)
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.
Read the 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.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Microdrop administration of phenylephrine 1.67% and tropicamide 0.33%, Standard drop administration of phenylephrine 1.67% and tropicamide 0.33%
- Keywords
- microdrops, mydriasis, dilating drops, phenylephrine, tropicamide, 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 of phenylephrine 1.67% and tropicamide 0.33%Drug
1 drop (6.5 μL) for 3 doses with 5-minute intervals
Standard drop administration of phenylephrine 1.67% and tropicamide 0.33%Drug
1 drop (28-34 μL) for 3 doses with 5-minute intervals
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Mydriasis with microdrops Receives: Drug: Microdrop administration of phenylephrine 1.67% and tropicamide 0.33% |
| Control Group | Active comparator | Mydriasis with standard drops Receives: Drug: Standard drop administration of phenylephrine 1.67% and tropicamide 0.33% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mydriatic efficacy: millimeters of horizontal pupil diameter.
Measured: 45 minutes after the first drop instillation.
Secondary outcomes (12)
Mydriasis sustainability: millimeters of horizontal pupil diameter.
Measured: 90 minutes after the first drop instillation.
Mydriasis sustainability: millimeters of horizontal pupil diameter.
Measured: 120 minutes after the first drop instillation.
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.
Measured: Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.
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.
Measured: Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.
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.
Measured: Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.
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.
Measured: Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.
Heart rate values (beats per minute).
Measured: 45, 90 and 120 minutes after the first drop instillation.
Oxygen saturation (SpO2) values (%).
Measured: 45, 90 and 120 minutes after the first drop instillation.
Systolic, diastolic, and mean blood pressure values (mmHg).
Measured: 45, 90 and 120 minutes after the first drop instillation. Hourly blood pressure measurements for the first 24 hours after mydriasis.
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).
Measured: During the 48 hours after mydriasis.
Number of participants with local adverse events.
Periorbital pallor, eyelid swelling, flushing.
Measured: 45 minutes after the first drop instillation.
Adequacy of judging the presence or absence of treatment-requiring ROP.
Measured: At the end of the eye examination (fundoscopy).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start7 Sep 2021
- Primary completion20 Jan 2023
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Responsible party
- Principal investigator, Asimina Mataftsi, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043077
- Sponsor's protocol ID
- 23265/14-07-2021
- Acronym
- MyMiROPS
- Status last verified
- Mar 2025
- First submitted
- 2 Sep 2021
- Last updated
- 18 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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 3662909Elibol 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 9197568Seliniotaki 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 32772218Seliniotaki AK, Lithoxopoulou M, Virgiliou C, Gika H, Dokoumetzidis A, Bougioukas KI, Raikos N, Diamanti E, Ziakas N, Haidich AB, Mataftsi A. Efficacy and Safety of Mydriatic Microdrops for Retinopathy of Prematurity Screening: The MyMiROPS Randomized Clinical Trial. JAMA Ophthalmol. 2025 Feb 1;143(2):110-116. doi: 10.1001/jamaophthalmol.2024.5462.
PubMed 39724200Seliniotaki 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.
PubMed 35428316
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening: a Non-inferiority Crossover Randomized Controlled Trial (MyMiROPS Trial)
- ClinicalTrials.gov ID
- NCT05043077
- Acronym / sponsor ID
- MyMiROPS / 23265/14-07-2021
- Conditions
- Retinopathy of Prematurity
- Keywords
- microdrops, mydriasis, dilating drops, phenylephrine, tropicamide, retinopathy of prematurity, ROP, screening
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Drug: Microdrop administration of phenylephrine 1.67% and tropicamide 0.33%Mydriasis with microdrops |
| Control Group | Active comparator | Drug: Standard drop administration of phenylephrine 1.67% and tropicamide 0.33%Mydriasis with standard drops |
Who may qualify
- Ages
- 30 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Unstable clinical condition
- Severe cardiovascular disease
- Congenital anomalies
- Clinical syndromes
- Inotropes' intake during the week prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microdrop administration of phenylephrine 1.67% and tropicamide 0.33%1 drop (6.5 μL) for 3 doses with 5-minute intervals | Drug | Study Group |
| Standard drop administration of phenylephrine 1.67% and tropicamide 0.33%1 drop (28-34 μL) for 3 doses with 5-minute intervals | Drug | Control Group |
Primary outcome
Mydriatic efficacy: millimeters of horizontal pupil diameter.
Time frame: 45 minutes after the first drop instillation.
12 secondary outcomes
Mydriasis sustainability: millimeters of horizontal pupil diameter.
Time frame: 90 minutes after the first drop instillation.
Mydriasis sustainability: millimeters of horizontal pupil diameter.
Time frame: 120 minutes after the first drop instillation.
Pharmacokinetic profile of phenylephrine: area under the whole blood concentration versus time curve (AUC).
Time frame: Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.
Pharmacokinetic profile of phenylephrine: maximum (peak) whole blood concentration (Cmax).
Time frame: Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.
Pharmacokinetic profile of phenylephrine: time to reach maximum (peak) whole blood concentration (Tmax).
Time frame: Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.
Pharmacokinetic profile of phenylephrine: elimination half-life (T1/2).
Time frame: Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.
Heart rate values (beats per minute).
Time frame: 45, 90 and 120 minutes after the first drop instillation.
Oxygen saturation (SpO2) values (%).
Time frame: 45, 90 and 120 minutes after the first drop instillation.
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.
Number of participants with systemic adverse events.
Time frame: During the 48 hours after mydriasis.
Number of participants with local adverse events.
Time frame: 45 minutes after the first drop instillation.
Adequacy of judging the presence or absence of treatment-requiring ROP.
Time frame: At the end of the eye examination (fundoscopy).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Background: PubMed 3662909Lynch 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.
- Background: PubMed 9197568Elibol 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.
- Background: PubMed 32772218Seliniotaki 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 publication: PubMed 39724200Seliniotaki AK, Lithoxopoulou M, Virgiliou C, Gika H, Dokoumetzidis A, Bougioukas KI, Raikos N, Diamanti E, Ziakas N, Haidich AB, Mataftsi A. Efficacy and Safety of Mydriatic Microdrops for Retinopathy of Prematurity Screening: The MyMiROPS Randomized Clinical Trial. JAMA Ophthalmol. 2025 Feb 1;143(2):110-116. doi: 10.1001/jamaophthalmol.2024.5462.
- Derived from this study: PubMed 35428316Seliniotaki 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Microdrop administration of phenylephrine 1.67% and tropicamide 0.33% and Standard drop administration of phenylephrine 1.67% and tropicamide 0.33% 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 9 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 18 Mar 2025. 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: millimeters of horizontal pupil diameter. (time frame: 45 minutes after the first drop instillation.). 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 NCT05043077, which also lists 5 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 18 Mar 2025.