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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.
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.
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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 [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 6-7 μL)] | Drug | 1 drop (6-7 μL) for 3 doses, 5 minutes' intervals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mydriatic efficacy: mm of pupil diameter (left and right eye) | 45 minutes after the first drop instillation | |
| Mydriatic efficacy: mm of pupil diameter (left and right eye) | 90 minutes after the first drop instillation |
| Measure | Description | Time Frame |
|---|---|---|
| Mydriatic efficacy: mm of pupil diameter (left and right eye) | 120 minutes after the first drop instillation | |
| Systemic side effects: measurements of Heart Rate (bpm) | 45 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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| 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 |
|
| Systemic side effects: measurements of Heart Rate (bpm) | 90 minutes after the first drop instillation |
| Systemic side effects: measurements of Heart Rate (bpm) | 120 minutes after the first drop instillation |
| Systemic side effects: measurements of oxygen saturation (SpO2) (%) | 45 minutes after the first drop instillation |
| Systemic side effects: measurements of oxygen saturation (SpO2) (%) | 90 minutes after the first drop instillation |
| Systemic side effects: measurements of oxygen saturation (SpO2) (%) | 120 minutes after the first drop instillation |
| Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg) | 45 minutes after the first drop instillation |
| Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg) | 90 minutes after the first drop instillation |
| Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg) | 120 minutes after the first drop instillation |
| Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg) | Hourly for the first 24 hours after mydriasis |
| Local side effects: periorbital pallor, eyelid swelling, flushing | 45 minutes after the first drop instillation |
| 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) | During the 24 hours after mydriasis for ROP screening |
| Number of participants with non-adequate mydriasis to fully visualize peripheral fundus according to the examiner | Upon eye examination (45 to 90 minutes after the first drop) |
| 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. |
| 34654903 | Result | 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. |
| 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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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| D014331 | Tropicamide |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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