Phenylephrine 5.4mg / Tropicamide 0.28mg ophthalmic inserts preservative free
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Mydriasert 5.4mg/0.28mg ophthalmic inserts
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Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing all 17 studies.
Reviews & meta-analyses: 1 · Randomised trials: 2 · 2023–2026
Showing all 17 studies, sorted by most relevant.
Xu X, Zhang LX, Jiang JJ
2025
AIM: To compare the efficacy of different administration regimens of compound tropicamide eyedrops (CTE) for pupil dilation for children with dark iris. METHODS: A 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. RESULTS: In 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 (P<0.01) and 60min (P<0.01). The effect of pupil dilation in Group 2 was 1.25 times that in Group 1. The change in pupil size was positively associated with age. A higher proportion of children in Group 1 had smaller pupil diameter and reactive pupils at the final time point, with only 33 children (33.7%) had final pupil size ≥6.5 mm, and only 9 children (9.2%) had non-reactive pupils. Children in Group 2 achieved larger pupil diameter and more non-reactive pupils at the final time point, with 84 children (87.5%) had final pupil size ≥6.5 mm, and only 22 children (22.9%) had reactive pupils. CONCLUSION: Increasing the frequency of compound tropicamide and lengthening the interval between eye drop applications can produce stronger mydriatic effects.
Abstract licence: CC BY-NC-ND
Peng X, Shang J, Chen Z, et al.
2025
- Choroid
- Intraocular Pressure
Purpose To assess retinal and choroidal changes following rapid mydriasis in healthy adults. Methods Seventy-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. Results Both central (tropicamide: 33.3%; mixture: 22.22%) and mid-peripheral (tropicamide: 28.47%; mixture: 36.81%) retinas thickened slightly postmydriasis (p<0.05, false discovery rate (FDR) corrected). Specifically, thickening primarily occurred in the temporal (tropicamide: 25.61%; mixture: 34.31%) and inferior (tropicamide: 50.00%; mixture: 35.29%) mid-peripheral regions. Outer retinal layer thickening correlated positively with overall retinal thickness in both groups (tropicamide: r=0.71, p<0.001; mixture: r=0.74, p<0.001). Choroidal stroma volume increased in 18 regions post-tropicamide treatment and in two regions postmixture treatment (p<0.05, FDR corrected). However, no significant differences were found in retinal vascular density, choroidal thickness, vascular density or matrix between the two groups premydriatic and postmydriatic administration (p > 0.05, FDR corrected). Conclusions Rapid 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
Li X, Chen X, Sun J, et al.
2025
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
M. Gioia, Maddalena De Bernardo, Sergio Pagliarulo, et al.
Journal of Clinical Medicine, 2023
The purpose of this study is to evaluate choroidal thickness (ChT) at the subfoveal and peripheral level after the instillation of 0.5% tropicamide + 10% phenylephrine 9 hydrochloride eye drops by using OCT scans in enhanced depth image (EDI) mode. In total, 53 patients (30 males and 23 females) were involved, and the mean age was 25.62 ± 2.41 (age range: 23–36). The dominant eye was treated with tropicamide + phenylephrine (Visumidriatic Fenil 100 mg/mL + 5 mg/mL, Visufarma) while the nondominant eye was used as the control. An OCT analysis was performed on both eyes before and 30 min after the instillation of a drop of mydriatic in the dominant eye. The ChT was measured by using the OCT software measurement tool (Spectralis; Heidelberg Engineering; Heidelberg, Germany, version 6.0). The results showed a statistically significant ChT decrease (p = 0.009) in the temporal sector after the treatment with tropicamide + phenylephrine. In the subfoveal and nasal sectors, no statistically significant ChT changes were detected (p = 0.94; p = 0.85) following the administration of the mydriatic eye drops. The ChT thinning in the temporal sector following the instillation of the tropicamide + phenylephrine eye drops suggests that in the case of ChT studies, mydriatic administration should be avoided.
Abstract licence: CC BY
Xu M, Li N, Liu Y, et al.
2025
- Choroid
- Anterior Chamber
- Cornea
OBJECTIVES: To evaluate the effects of short-acting cycloplegic agents, tropicamide and compound tropicamide, on ocular biological parameters and choroid thickness. METHODS: In this study, seventy pediatric subjects aged 6 to 13 years were randomly assigned to two groups: the tropicamide group and compound tropicamide group. Ocular biological parameters and choroidal thickness (CT) and subfoveal choroid thickness (SFCT) were measured in both groups and were retested 40 min after drug administration. The tropicamide eye drops were administered into the conjunctival sac every 5 min with 1 drop, for a total of 4 doses. Compound tropicamide was administered in the same way as tropicamide. Ocular biological parameters included refraction (spherical equivalent, SE), intraocular pressure (IOP), axial length (AL), anterior chamber depth (ACD), lens thickness (LT), central corneal thickness (CCT), and white to white (WTW). The CT is the regional inferior choroidal thickness of nine sectors centered on the macular fovea and automatically generated using an ETDRS grid. And the SFCT is the choroidal thickness at the subfoveal point of the macular region. RESULTS: After application of tropicamide and compound tropicamide to induce the ciliary muscle paralysis, SE, AL, and LT decreased, while ACD, CCT, and WTW increased compared to baseline(all P values < 0.05). There was no significant change in IOP before and after cycloplegia (p > 0.05). The CT in the nasal quadrant before and after ciliary paralysis was significantly thinner than other areas, the CT in the temporal quadrant was significantly thicker than others, and the CT in the inner quadrant was higher than the CT in the outer quadrant. In the tropicamide group: CT was significantly increased in the remaining quadrants except the inner inferior(I) and outer superior(S) quadrants (p < 0.05), and SFCT was also significantly increased (p = 0.005). In the compound tropicamide group: there is a significant increase in CT outer superior(S) quadrant CT (p = 0.043). Increase in the mean values of CT and SFCT in the remaining quadrants was also observed, but the difference was not statistically significant (p > 0.05). Additionally, AL and SFCT were negatively correlated. CONCLUSIONS: Some ocular biological parameters were altered after application of short-acting cycloplegic agent tropicamide and compound tropicamide to paralyze the ciliary muscle. Compared with compound tropicamide, tropicamide eye drops can reduce axial length while increasing choroid thickness.
Abstract licence: CC BY-NC-ND
P. Prasher, V. Vig, Brahmjot Singh, et al.
Indian Journal of Ophthalmology, 2023
- Mydriatics
- Mydriasis
- Cornea
Purpose: The purpose of the study is to investigate the effects of combined 0.8% tropicamide and 5% phenylephrine on the corneal parameters using Pentacam. Methods: The study was performed on 200 eyes of 100 adult patients visiting the ophthalmology clinic for evaluation of refractive errors or cataract screening. Mydriatic drops (Tropifirin; Java, India) containing tropicamide 0.8%, phenylephrine hydrochloride 5%, and chlorbutol 0.5% (as a preservative) were instilled into the eyes of the patients three times every 10 minutes. The Pentacam was repeated after 30 minutes. The measurement data of various corneal parameters from different Pentacam displays (keratometry, pachymetry, densitometry, and Zernike analysis) was manually compiled on an Excel spreadsheet and analyzed using Statistical Package for the Social Sciences (SPSS) 20 software. Results: Analysis of Pentacam refractive maps revealed a statistically significant increase (P < 0.05) in the values of radius peripheral (cornea front), pupil center Pachymetry, pachymetry apex, thinnest location Pachymetry, and cornea volume. However, pupil dilation did not affect the Q-value (asphericity). Analysis of the densitometry values revealed significant increase in all zones. Aberrations maps revealed statistically significant increase in the value of spherical aberration after the induction of mydriasis, but the values of Trefoil 0º, Trefoil 30º, Koma 90º, and Koma 0º were not affected significantly. We did not observe any untoward effect of the drug, except transient blurring of vision. Conclusion: The current study showed that routine mydriasis in the eye clinics leads to a significant increase in various corneal parameters including corneal pachymetry, cornea densitometry, and spherical aberration as measured by Pentacam, which can influence the decision-making in the management of various corneal diseases. The ophthalmologists should be aware of these issues and make adjustments in their surgical planning accordingly.
Abstract licence: CC BY-NC-SA
Bayyoud T, Bartz-Schmidt KU, Rohrbach M, et al.
2025
Purpose: To assess clinical outcomes after Descemet’s Membrane Endothelial Keratoplasty (DMEK) with mydriatic eye drops without peripheral iridotomy (PI-less). We performed a retrospective, observational clinical study to determine the postoperative intraocular pressure (IOP) changes and graft viability in a cohort of patients with Fuchs’ endothelial corneal dystrophy (FECD) and bullous keratopathy (BK). Patients and Methods: Included in this study were 41 PI-less DMEK patients with 44 eyes (median age: 77 years; range: 53– 88 years). Patients received either PI-less DMEK (group-1) or PI-less triple DMEK (group-2). The mean follow-up duration was 16 months. Eyes after standard DMEK or triple DMEK served as controls (n = 20). Included in the study were patients admitted to the hospital (securing IOP control), patients in which the tamponading agent was air or gas (SF6) and only patients with physiological air resorption, ie without routine, postoperative air/gas release (90% air/gas fill of the anterior chamber at end of surgery). Phakic eyes were not included. Postoperatively, mydriatic eye drops were administered for three days 4x/d (phenylephrine 25 mg/mL, tropicamide 5 mg/mL). The best-corrected visual acuity (BCVA), endothelial cell density (ECD), and IOP were assessed. Intra- and postoperative complications and management were recorded. Results: BCVA improved significantly in both groups (group-1:0.90 ± 0.57 to 0.20 ± 0.23logMAR (p = 0.000); group-2:0.47 ± 0.23 to 0.17 ± 0.42logMAR (p = 0.0067). ECD decreased significantly: Group-1 2428± 225 cells/mm 2 to 1810± 236 cells/mm 2 (p = 0.005); group-2 2447 ± 178 cells/mm 2 to 1866 ± 229 cells/mm 2 (p = 0.012). After postoperative day-1 IOP decreased significantly: Group-1 p = 0.004 (10.0 ± 2.8 mmHg) and p = 0.002 (11.3 ± 3.1 mmHg); group-2 p = 0.002 (10.7 ± 3.6 mmHg) and p = 0.002 (11.4 ± 2.2 mmHg); for postoperative days 2 and 3, respectively. Postoperative adverse events included pupillary block necessitating emergency air release. Intergroup analysis did not show a significant difference in ECD, IOP (after postoperative day-1) and logMAR (after 6 months). Conclusion: Patients may benefit from the promising results of the study regarding postoperative IOP developments and graft viability after DMEK using mydriatic eye drops (phenylephrine 25 mg/mL, tropicamide 5 mg/mL). PI-less triple DMEK in particular might improve accessibility, reduce surgical complexity, or lower costs, making it attractive in resource-limited settings. Close postoperative IOP monitoring is advised in PI-less DMEKs. Plain Language Summary: What is already known on this topic The standard procedure for a lamellar corneal transplant (DMEK) involves the placement of a peripheral iridotomy (PI) or iris hole;If corneal transplant surgery without PI (PI-less DMEK) is performed, then partial evacuation of air/gas from the anterior chamber of the eye 1-2 h after surgery besides postoperative pupil-dilating medication (mydriatics, phenylephrine 25 mg/mL, tropicamide 5 mg/mL) is necessary to avoid potentially sight-threatening increase in eye pressure (so-called pupillary block). What this study adds Patients benefit from a DMEK without an iris hole, from having no routine postoperative air/ gas release and having no significantly increased risk of pupillary block;For the first time we have shown that the results of a PI-less triple DMEK (including cataract surgery) and a PI-less DMEK are comparable. How this study might affect research, practice or policy ● The investigated PI-less triple DMEK procedure incorporating cataract surgery might offer unique benefits for the patients: This approach might improve accessibility, reduce surgical complexity, or lower costs, making it attractive in resource-limited settings. Keywords: descemet membrane endothelial keratoplasty, DMEK, pupil-dilating eye drops, no peripheral iridotomy, PI-less
Abstract licence: CC BY-NC
Donghee Kim, S. Park, Haerin Yoon, et al.
Veterinary Ophthalmology, 2025
- Intraocular Pressure
- Mydriatics
- Dog Diseases
PURPOSE: To determine whether the differences in intraocular pressure (IOP) change after the topical application of 0.5% tropicamide and 0.5% phenylephrine (TP) are due to anatomical variations in the anterior chamber using ultrasound biomicroscopy (UBM). METHODS: Prospective clinical data from 27 eyes of 14 dogs with normal eye conditions were analyzed. IOP and UBM measurements were taken before and 30 min after administering a topical TP. Dogs were categorized into two groups based on an IOP increase criterion of 4 mmHg: the high group and the stable group. Parameters measured included the iridocorneal angle (ICA), angle-opening distance (AOD), ciliary cleft width (CCW), length (CCL), area (CCA), ciliary body axial length (CBAXL), and ciliary process-sclera angle (CPSA). RESULTS: Both groups showed a statistically significant decrease in ICA and an increase in AOD. However, in the stable group, CPSA increased, CBAXL decreased, and CCA increased, whereas in the high group, CPSA and CBAXL did not change significantly, and CCA decreased. CONCLUSION: In the stable group, although the pupil dilated, the ciliary body relaxed, leading to an increase in the CCA. Conversely, in the high group, the pupil dilated, and the ciliary body remained unrelaxed, resulting in a reduction in the CCA. These iridociliary changes with pupil dilation increase the risk of elevated IOP. Therefore, an increase in IOP following TP administration may serve as a prognostic indicator for possible glaucoma risk.
Abstract licence: CC BY
Lin J, Chen T, Lin Z, et al.
2025
- Accommodation, Ocular
- Myopia
- Biometry
• Optical fogging reduces myopic overestimation by up to 36.84% compared to cycloplegia. • The technique is non-invasive, easy to apply, and well-tolerated by young adults. • Optical fogging induces 0.28D relaxation in overestimated myopic eyes. • Fogging effectively suppresses accommodation, improving refractive measurement accuracy. • Optical fogging offers a practical alternative to cycloplegia for clinical refraction. This study aimed to investigate the effectiveness of optical fogging in controlling accommodation and to evaluate its efficiency in reducing myopic overestimation among young adults, with the goal of providing scientific evidence for clinical refraction measurement. A total of 142 young adults aged 17 to 23 years (284 eyes) were enrolled. Refractive status and ocular biometric parameters were measured using open-field autorefractor and partial coherence interferometry under three conditions: baseline, optical fogging, and cycloplegia. Optical fogging was induced by wearing +2.00 D spherical lenses for 20 minutes, while cycloplegia was induced using 0.5% compound tropicamide-phenylephrine eye drops. Eyes were categorized into overestimated and non-overestimated myopia groups based on whether the difference in spherical equivalent (SE) between cycloplegic and baseline measurements was ≥0.50 D. Changes in SE and lens thickness under the three conditions were analyzed, and the efficiency of fogging-induced accommodative control was calculated. In the overestimated myopia group (82 eyes), optical fogging reduced accommodation by an average of 0.28 ± 0.37 D compared to baseline (p < 0.001), accounting for 36.84% of the effect of cycloplegia (0.76 ± 0.29 D). In the total sample eyes, fogging reduced accommodation by 0.07 ± 0.34 D (p < 0.001), which corresponded to 21.88% of the cycloplegic effect (0.32 ± 0.37 D). Lens thickness showed no significant change after optical fogging, whereas cycloplegia significantly reduced lens thickness (overestimated myopia group: -0.07 ± 0.10 mm, p = 0.003; total: -0.05 ± 0.19 mm, p < 0.001). Optical fogging effectively suppresses unnecessary accommodative responses in young adults, significantly reducing myopic overestimation, with particularly pronounced effects in those with notable myopic overestimation. Although optical fogging is less effective than cycloplegia in relaxing accommodation, it offers advantages in terms of ease of use, non-invasiveness, and good tolerance, making it highly applicable in clinical refraction measurement.
Abstract licence: CC BY-NC-ND
Marina Dewi Fitriyani, Sawitri Boengas, Jefman Efendi Marzuki, et al.
Journal of Clinical Ophthalmology and Research, 2025
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Scientific data (pharmacology, interactions, ADME) is not yet available for this medicine. Clinical sections are sourced from the NHS dm+d database.