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| Name | Class |
|---|---|
| National and Kapodistrian University of Athens | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Mydriasis with microdrops |
|
| Control Group | Active Comparator | Mydriasis with standard drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microdrop administration of phenylephrine 1.67% and tropicamide 0.33% | Drug | 1 drop (6.5 μL) for 3 doses with 5-minute intervals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mydriatic efficacy: millimeters of horizontal pupil diameter. | 45 minutes after the first drop instillation. |
| Measure | Description | Time Frame |
|---|---|---|
| Mydriasis sustainability: millimeters of horizontal pupil diameter. | 90 minutes after the first drop instillation. | |
| Mydriasis sustainability: millimeters of horizontal pupil diameter. | 120 minutes after the first drop instillation. |
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Inclusion Criteria:
Preterm infants undergoing screening for ROP, i.e.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Papageorgiou General Hospital | Thessaloniki | 56429 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3662909 | Background | 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. | |
| 9197568 | Background | 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. |
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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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| Standard drop administration of phenylephrine 1.67% and tropicamide 0.33% | Drug | 1 drop (28-34 μL) for 3 doses with 5-minute intervals |
|
| 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. | 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. | 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. | 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. | 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). | 45, 90 and 120 minutes after the first drop instillation. |
| Oxygen saturation (SpO2) values (%). | 45, 90 and 120 minutes after the first drop instillation. |
| Systolic, diastolic, and mean blood pressure values (mmHg). | 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). | During the 48 hours after mydriasis. |
| Number of participants with local adverse events. | Periorbital pallor, eyelid swelling, flushing. | 45 minutes after the first drop instillation. |
| Adequacy of judging the presence or absence of treatment-requiring ROP. | At the end of the eye examination (fundoscopy). |
| 32772218 | Background | 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. |
| 39724200 | Result | Seliniotaki 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. |
| 35428316 | Derived | 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. |
| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| D015878 | Mydriasis |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011681 | Pupil Disorders |
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