Phenylephrine 1% / Cyclopentolate 0.2% eye drops
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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
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Reviews & meta-analyses: 1 · Randomised trials: 1 · 2018–2026
Showing all 13 studies, sorted by most relevant.
L. Kremer, N. Medlicott, M. Sime, et al.
Archives of Disease in Childhood. Fetal and Neonatal Edition, 2023
- Cyclopentolate
- Retinopathy of Prematurity
- Birth Weight
OBJECTIVE: To determine if very low dose (VLD, 0.5% phenylephrine, 0.1% cyclopentolate) mydriatic microdrop (approximately 7 μL) administration (up to three doses) is non-inferior to low dose (LD, 1% phenylephrine, 0.2% cyclopentolate) mydriatic microdrop administration for ophthalmologist-determined successful retinopathy of prematurity eye examination (ROPEE). DESIGN: Multicentre, prospective, randomised controlled, non-inferiority clinical trial. SETTING: Four neonatal intensive care units in Aotearoa, New Zealand from October 2019 to September 2021. PATIENTS: Infants with a birth weight less than 1250 g or gestational age less than 30+6 weeks and who required a ROPEE. INTERVENTIONS: The intervention: microdrop (approximately 7 μL) of VLD (0.5% phenylephrine and 0.1% cyclopentolate) to both eyes, or the comparison: microdrop of LD (1% phenylephrine and 0.2% cyclopentolate) to both eyes. Up to three doses could be administered. MAIN OUTCOME MEASURES: The primary outcome measure was an ophthalmologist-determined successful ROPEE. RESULTS: One hundred and fifty preterm infants (LD mean GA=27.4±1.8 weeks, mean birth weight=1011±290 g, VLD mean GA=27.5±1.9 weeks, mean birth weight=1049±281 g,) were randomised. Non-inferiority for successful ROPEE was demonstrated for the VLD group compared with the LD group (VLD successful ROPEE=100%, LD successful ROPEE=100%, 95% CI no continuity correction -0.05 to 0.05) and for Māori (95% CI no continuity correction -0.02 to 0.19). CONCLUSION: VLD microdrops enable safe and effective screening for ROPEE in both Māori and non-Māori preterm infants. TRIAL REGISTRATION NUMBER: ACTRN12619000795190.
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
Yunyun Sun, S. Wei, Shiming Li, et al.
British Journal of Ophthalmology, 2018
Curi I, Nakayama SA, Pereira ÉM, et al.
2023
Cycloplegia is crucial for reliable pediatric ophthalmology examinations. This document provides a re-commendation for pediatric cycloplegia and mydriasis for Brazilian ophthalmologists. This article was developed based on literature reviews; the clinical experience of Brazilian specialists, as obtained through questionnaires; and the consensus of the Expert Committee of the Brazilian Pediatric Ophthalmology Society. According to the best evidence and formulations available in Brazil, this committee recommends the use of one drop of 1% cyclopentolate plus one drop of 1% tropicamide in children older than 6 months and two drops of 1% tropicamide 0-5 minutes apart for those younger than 6 months. Mydriasis may be increased by a single drop of 2.5% phenylephrine. For retinopathy of prematurity screening, the recommendation is 0.5% or 1% tropicamide, administered two or three times, 5 minutes apart, and 2.5% phenylephrine, used preferably once. In all scenarios, we recommend the use of a prior drop of 0.5% proxymetacaine.
Abstract licence: CC BY-NC
Aldamri A, AlKhaldi SA, Alshuhayb BS, et al.
2024
PURPOSE: The purpose of this study was to explore the side effects of using cycloplegic eye drops at ophthalmology clinics at King Saud Medical City (KSMC) in Riyadh, Saudi Arabia. Moreover, to have an insight into physicians' attitude towards the management of these side effects. METHODS: A retrospective cross-sectional study where medical records of pediatric patients who attended ophthalmology clinics at KSMC. Subjects were selected after reviewing their files and based on their reaction to the ocular drops. In addition, the response of ophthalmologists was obtained through a questionnaire distributed through electronic channels. RESULTS: A total of 111 patients' medical records were included in this study. The most reported cycloplegic agents that caused side effects were cyclopentolate 1%, tropicamide 1%, and phenylephrine 2.5%. Fifty-three percentage of physicians reported that changing their way of administering cycloplegic drops in practice plays a role in reducing some side effects. The most reported side effects of using cycloplegic eye drops were facial flushing 68%, followed by fever 46%, and irritability 38% of cases. Few children who experienced side effects needed medical intervention. CONCLUSION: Side effects caused by cycloplegic agents are usually mild and rarely severe. There are some systemic side effects such as hallucinations, psychosis, or seizures. Proper parental counseling before administering cycloplegic agents and proper clinical management in case of severe side effects is crucial. Prophylactic measures to reduce the incidence of these side effects are advisable.
Abstract licence: CC BY-NC-SA
Chua MJ, Varshney N, Eke T
2024
- Iris Diseases
- Iatrogenic Disease
- Intraoperative Complications
Phenylephrine, a potent sympathomimetic, induces mydriasis via iris dilator muscle contraction. Intracameral (IC) phenylephrine has been successfully used in cataract surgery for initial mydriasis, maintaining mydriasis, and management of intraoperative floppy-iris syndrome. Serious systemic adverse events (mainly cardiovascular) have been described with topical phenylephrine drops, but we found very little evidence of such adverse events associated with IC phenylephrine use. However, we suspect under-reporting of such adverse events, as they may instead be ascribed to anxiety, positioning, anesthesia, etc. Optimal dosage/concentrations for IC phenylephrine use in different purposes have not been fully studied. In the absence of robust evidence, we suggest that lower but effective IC phenylephrine concentrations are used: a lower concentration (0.31%), in conjunction with an anticholinergic and lidocaine, may be used for initial mydriasis. For management of intraoperative floppy-iris syndrome, 0.31% may be effective, though a higher concentration (1% to 1.25%) may be required.
Abstract licence: CC BY-NC-ND
Kim D, Park SE, Yoon H, et al.
2026
- 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
Kaiser KP, Lwowski C, Nazir F, et al.
2025
- Cyclopentolate
- Mydriatics
- Pupil
PURPOSE: To compare the refraction before and after cycloplegia with 0.5% and 1.0% cyclopentolate eye drops using five different measurement modalities. METHODS: This prospective, clinical comparative study enrolled 96 eyes of 48 healthy patients with a mean age of 26.6 ± 4.21 years (range: 19-34). Subjective refraction, retinoscopy, and objective refraction were measured using three autorefractometers: Topcon KR-800 (TC), Retinomax K-plus 3 (RM + 3), and Retinomax K-plus Screeen (RM + S) under noncycloplegic and cycloplegic conditions. Cycloplegia was performed in the right eye using 0.5% and in the left eye with 1.0% cyclopentolate eye drops. Differences in refraction in noncycloplegia and cycloplegia, between cycloplegia with 0.5% and 1.0% cyclopentolate, and between the devices were investigated. RESULTS: Cycloplegic mean spherical equivalent was -1.77 ± 2.34 diopters (D) (-9.75 to + 1.625). All approaches showed a statistically significant hyperopic shift (p < 0.001, each) after induction of cycloplegia using both regimes. Lowest median (interquartile range) hyperopic shift was shown by TC (0.25 D (0.38)) and retinoscopy (0.25D (0.75)), and the highest by RM + 3 (0.75 (1.31)). No statistically significant differences between cycloplegia using 0.5% and 1.0% regimens were shown in all modalities (p > 0.05, each). In noncycloplegia, there were greater differences compared to cycloplegia. No influence of iris color on the refraction was found. CONCLUSION: After induction of cycloplegia all devices showed a hyperopic shift and good comparability to retinoscopy. In all measurement modalities, no significant refraction differences between 0.5% and 1.0% cyclopentolate eye drops were seen. Therefore, 0.5% cyclopentolate was proven to have a sufficient effect with presumably better tolerability. KEY MESSAGES: What is known Cycloplegic refraction is a key test in the evaluation of any patient with active accommodation. The most frequently used clinical tests to determine the exact refraction are retinoscopy, subjective refraction, and objective refraction using autorefractometry. What is new No significant differences in the refraction between cycloplegia using 0.5% and 1.0% cyclopentolate eye drops were found. In noncycloplegia, hand-held autorefractometers tend to measure higher myopia. The evaluation of cycloplegic refraction showed good comparability between retinoscopy and subjective refraction as well as three different autorefractometers.
Abstract licence: CC BY
Asharlous A, Hashemi H, Yekta A, et al.
2024
Purpose: The present study sets out to investigate the effect of cyclopentolate-induced cycloplegia on distance and near deviation and the accommodative convergence/accommodation (AC/A) ratio. Methods: This prospective study was performed on 30 subjects. The inclusion criteria included a lack of any active ocular pathology and systemic diseases, no history of ocular surgery, and nonuse of various medications. Refraction, near and distance deviation were measured for all subjects, and the same examinations were repeated after the administration of two drops of cyclopentolate 1% to both eyes. Results: The obtained data from 30 subjects, including 19 males, with a mean age of 22.53 ± 1.74 years were analyzed. The mean ± SD of near deviation in dry and cycloplegic conditions were – 6.9 ± 8.1 and +6.4 ± 9.1 prism diopters, respectively, which were statistically significant (P < 0.001). Distance deviation in cycloplegic conditions demonstrated an average difference of 0.8 prism diopters, compared to dry conditions (P < 0.001). AC/A ratios were 4.7 ± 2.5 and 9.7 ± 3.9 (Δ/D) in non-cycloplegic and cycloplegic conditions, respectively, which was a statistically significant difference (P < 0.001). The multiple regression indicated that among all under study variables, refraction (B coefficient: –2.4; P < 0.001) and near pre-cycloplegic deviation (B coefficient: 0.56; P < 0.001) were significantly associated with post-cycloplegic near deviation. Conclusion: The results of this study indicated that cycloplegia causes a considerable esophoric shift in near deviation and a negligible esophoric shift in distance deviation. As a result, the AC/A ratio demonstrated a significant increase due to unequal changes in near and distance deviation.
Abstract licence: CC BY
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.