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
Showing the 50 most relevant studies.
Reviews & meta-analyses: 2 · Randomised trials: 5 · Trials: 1 · 1986–2026
Showing the 50 most relevant studies, sorted by most relevant.
Lisa Jean Kremer, Natalie Medlicott, Mary Jane Sime, et al.
Archives of Disease in Childhood - Fetal and Neonatal Edition, 2023
- Retinopathy of Prematurity
- Cyclopentolate
- Pupil
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 4.0
Ruxia Pei, Zhuzhu Liu, H. Rong, et al.
BMC Ophthalmology, 2021
- Refractive Errors
- Cyclopentolate
- Tropicamide
Lisa Jean Kremer, Roland Broadbent, Natalie Medlicott, et al.
Archives of Disease in Childhood, 2020
- Pupil
- Retinopathy of Prematurity
- Phenylephrine
Pei R, Liu Z, Rong H, et al.
2021
Li X, Chen X, Sun J, et al.
2025
Kittisak Kulvichit
Contreras-Salinas H, Orozco-Ceja V, Romero-López MS, et al.
2022
Cycloplegic and mydriatic agents are essential in ophthalmological clinical practice since they provide the means for diagnosing and treating certain eye conditions. In addition, cyclopentolate has proven to possess certain benefits compared to other available cycloplegics and mydriatics. Still, the incidence of some adverse drug reactions related to this drug, especially in susceptible patients, has created interest in reviewing the literature about the benefits and risks of using cyclopentolate. A literature search was conducted in Medline/PubMed and Google Scholar, focusing on identifying cyclopentolate's benefits and risks; the most important benefit was its usefulness for evaluating refractive errors, especially for hyperopic children, pseudomyopia, anterior uveitis, treatment of childhood myopia, idiopathic vision loss, and during examinations before refractive surgery, with particular advantages compared to other cycloplegics. While the risks were divided into local adverse drug reactions such as burning sensation, photophobia, hyperemia, punctate keratitis, synechiae, and blurred vision, which are relatively frequent but mild and temporary; and systemic adverse drug reactions such as language problems, visual or tactile hallucinations and ataxia, but unlike ocular, systemic adverse drug reactions are rare and occur mainly in patients with risk factors. In addition, six cases of abuse were found. The treatment with cyclopentolate is effective and safe in most cases; nevertheless, special care must be taken due to the potential severe ADRs that may occur, especially in susceptible patients like children, geriatrics, patients with neurological disorders or Down's syndrome, patients with a low blood level of pseudocholinesterase, users of substances with CNS effects, and patients with a history of drug addiction. The recommendations are avoiding the use of 2% cyclopentolate and instead employing solutions with lower concentrations, preferably with another mydriatic such as phenylephrine. Likewise, the occlusion of the nasolacrimal duct after instillation limits the drug's absorption, reducing the risk of systemic adverse events.
Abstract licence: CC BY-NC
Yunyun Sun, Shifei Wei, Shiming Li, et al.
British Journal of Ophthalmology, 2018
Gioia M, De Bernardo M, Pagliarulo S, et al.
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
Aljawhara Aldamri, Saleh A Alkhaldi, Bayan S. Alshuhayb, et al.
Saudi Journal of Ophthalmology, 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
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.