Phenylephrine 5.4mg / Tropicamide 0.28mg ophthalmic inserts preservative free

AimTo compare the efficacy of different administration regimens of compound tropicamide eyedrops (CTE) for pupil dilation for children with dark iris.MethodsA prospective, comparative, randomized interventional study was conducted. Children in Group 1 received CTE 3 times with a 3min interval between each application. Children in Group 2 received CTE 4 times with a 5min interval between each application. We measured their pupil diameters at baseline (pre-drug instillation) and 30min and 60min post-drug instillation and assessed the pupillary light reflex at 60min post-drug instillation.ResultsIn total, 194 eyes of 101 children were enrolled. The changes of pupil diameter at 30min and 60min post-drug instillation were 1.2±0.6 mm and 2.3±1.0 mm in Group 1, and 2.3±0.9 mm and 3.7±1.0 mm in Group 2, respectively. Group 2 showed a larger change in pupil size than Group 1 at 30min (PPConclusionIncreasing the frequency of compound tropicamide and lengthening the interval between eye drop applications can produce stronger mydriatic effects.

Abstract licence: CC BY-NC-ND

PurposeTo assess retinal and choroidal changes following rapid mydriasis in healthy adults.MethodsSeventy-one volunteers (71 right eyes) participated in a prospective randomised controlled trial. They were divided into two groups: tropicamide (n=36) and a mixture (tropicamide:phenylephrine=1:1, n=35) groups. Ophthalmic examinations included visual acuity, intraocular pressure and axial length measurements. Ultra-widefield swept-source optical coherence tomography angiography was used to assess retinal and choroidal parameters before and after mydriasis. This technique covers a 24×20 mm² area, allowing for non-invasive, simultaneous structural and haemodynamic assessment of retinal and choroidal regions.ResultsBoth central (tropicamide: 33.3%; mixture: 22.22%) and mid-peripheral (tropicamide: 28.47%; mixture: 36.81%) retinas thickened slightly postmydriasis (p>0.05, FDR corrected).ConclusionsRapid mydriasis causes slight retinal thickening, the slight change in the outer layer, particularly in the temporal and inferior regions. There were no significant changes in the choroid parameters following mydriasis, except for choroidal stroma volume. The limitation of this study was the small sample size and the absence of a control group.

Abstract licence: CC BY-NC

Introduction: Screening for ROP and its severity require optimum pupillary dilatation. Mydriatics that allow good dilatation often have systemic side effects. Topical tropicamide is considered safest but does not dilate pupils optimally. A combination of phenylephrine and tropicamide is a good mydriatic but has adverse effects. The study aims to compare the mydriatic efficacy of phenylephrine (P 2.5%) plus tropicamide (T 0.4%) versus tropicamide (T 1%) alone for ROP screening. Methods: Preterm neonates due for ROP screening were randomized to one of the two groups. One drop was instilled in the eye thrice every 15 mins. Pupillary diameter was recorded as a primary outcome measure using the Schirmer’s strip at baseline, 15, 30, and 45 minutes after drop instillation. Oxygen saturation, heart rate, and respiratory rate were measured at similar intervals. Adverse effects like apneas, vomiting, and feed intolerance were documented. Ophthalmologist comments on the visibility of different retinal zones were also recorded. Data were analyzed by t -test and Chi-square test as appropriate. Results: Fifty-four preterm babies were included (27 in each group). The birth weight (1130 ± 300g, 1220 ± 460 g) and gestation (34.40 ± 2.26 and 34.74 ± 3.24) weeks were similar in both groups. The pupillary size after 45 minutes in group 1 (7.56 ± 1.12 mm) was significantly greater ( P < 0.001) than that of group 2 (5.92 ± 0.90 mm). The visibility of retinal zones was better in group 1 compared to group 2, which was statistically significant ( P < 0.01). There was no significant difference between the two groups in saturation, heart rate, and respiratory rate at 30 mins and 45 mins. Conclusion: A combination of phenylephrine and tropicamide is a more effective mydriatic with no increase in adverse effects.

Abstract licence: CC BY-NC-SA 4.0

Abstract Background Pharmacologic mydriasis is essential for retinopathy of prematurity (ROP) screening; however, conventional ophthalmic drops substantially exceed neonatal tear film capacity, leading to systemic absorption and potential adverse effects. Microdrop administration may reduce drug exposure while preserving adequate pupillary dilation. This study aimed to determine whether microdrop administration of phenylephrine and tropicamide is noninferior to standard drops in achieving adequate mydriasis for ROP screening via a bottle adapter. Methods This single-center, randomized, parallel-group noninferiority trial was conducted in a tertiary neonatal unit in Chennai, India. Preterm infants undergoing routine ROP screening were randomized to receive either microdrops (10.26 µL) or standard drops (26.58 µL) of 2.5% phenylephrine and 0.8% tropicamide. Three doses were administered at 10-minute intervals. The primary outcome was the mean pupil diameter at 45 minutes after the first instillation. The secondary outcomes included physiological parameters (heart rate, oxygen saturation, and blood pressure), systemic and local adverse events, and the adequacy of ROP examination. A noninferiority margin of − 0.5 mm was prespecified. Results Among the 127 infants assessed for eligibility, 102 were randomized (microdrop group, n = 52; standard group, n = 50), and all completed the study. Baseline characteristics were comparable between the groups. The mean pupil diameter at 45 minutes was 6.54 ± 0.52 mm in the microdrop group and 6.38 ± 0.63 mm in the standard group (mean difference, 0.16 mm; 95% CI − 0.07–0.38), demonstrating noninferiority. Physiological parameters, including heart rate, oxygen saturation, and blood pressure, remained stable and comparable between the groups. Systemic adverse events were rare and similar across groups, and no local ocular complications were observed. ROP examination was successfully completed in all infants. Conclusion Microdrop administration of phenylephrine and tropicamide achieved mydriasis comparable to that of standard drops without increased adverse effects. This approach may represent a safer, clinically feasible and more physiologically appropriate strategy for ROP screening by reducing drug exposure in vulnerable preterm infants. Trial registration The study protocol was approved by the Institutional Ethics Committee of Madras Medical College, Chennai (IEC No. MMC/Approval/12052025). The trial was registered with the Clinical Trials Registry of India (CTRI/REF/2025/03/101681)on 10-03-2025.

Abstract licence: CC BY 4.0

Abstract Objectives: To assess and compare the effects of tropicamide 0.5% and tropicamide 1% on intraocular pressure (IOP) and pupil diameter (PD) in patients with diabetes mellitus. Methods : A total of 98 eyes of 98 diabetic patients were included in this double-masked randomized clinical trial. Patients were randomly assigned to receive either tropicamide 0.5% (49 eyes) or tropicamide 1% (49 eyes). IOP was measured by Goldmann applanation tonometry; PD was measured by Pentacam HR (Oculus Optikgeräte GmbH, Wetzlar, Germany), before and 30 min after tropicamide administration. Results: Mean PD change and IOP change was 2.99 ± 0.62 mm and 0.12 ± 1.71 mm Hg in tropicamide 0.5% group, and was 3.11 ± 0.55 mm and 0.25 ± 1.70 mm Hg in tropicamide 1% group, with no significant difference (P = 0.31, P = 0.72, respectively). No participants had IOP increase of 5 mm Hg or more. Conclusion: The effect of tropicamide 0.5% and tropicamide 1% drops on IOP and PD was similar. Mydriasis with tropicamide did not result in significant IOP change.

Abstract licence: CC BY 4.0

This case report describes a rare instance of heart failure temporally associated with the administration of mydriatic eye drops during routine retinopathy of prematurity screening. A 36-week-old preterm infant developed acute tachypnea, tachycardia, and hepatomegaly shortly after receiving 0.5% tropicamide and 0.5% phenylephrine, and was subsequently diagnosed with heart failure, which responded well to intravenous deslanoside. Cardiac imaging later revealed multiple congenital anomalies, including an atrial septal defect, persistent left superior vena cava, and horseshoe lung, among others. No similar cardiovascular symptoms were observed during a subsequent screening using tropicamide alone, suggesting that phenylephrine may have contributed to the observed hemodynamic instability. This case illustrates the potential for severe cardiovascular complications associated with mydriatic agents in neonates with undiagnosed congenital heart defects. It underscores the need for individualized risk assessment, vigilant monitoring, and cautious application of mydriatic protocols to ensure patient safety in high-risk preterm populations.

Abstract licence: CC BY-NC 4.0