Studies side effects of eye drops tropicamide and phenylephrine in hospitalized adults
Observes side effects of eye drops tropicamide and phenylephrine in hospitalized adults over 18.
Plain-language title generated from the registry record
Registry title: Clinical Determinants and Adverse Reactions to Tropicamide/Phenylephrine in Hospitalized Patients.
Key facts
- Where
- Mexico City, MexicoSee the site
Where in Mexico
- Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede CentroMexico City, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto de Oftalmología Fundación Conde de Valenciana
- Trial code
- NCT07178600
- Record updated
- 17 September 2025
- Original description
To evaluate the association between clinical determinants and the occurrence of adverse drug reactions in hospitalized patients who received tropicamide/phenylephrine 8 mg/50 mg/mL.Read full original descriptionShow less
Characterization and Association of Clinical Determinants With the Occurrence of Adverse Drug Reactions Following the Administration of Tropicamide/Phenylephrine in Hospitalized Patients.
To evaluate the association between clinical determinants and the occurrence of adverse drug reactions in hospitalized patients who received tropicamide/phenylephrine 8 mg/50 mg/mL.
An ambispective, interventional, longitudinal study will be conducted to actively identify adverse reactions to tropicamide/phenylephrine 8 mg/50 mg/mL, as well as the clinical determinants that may predispose patients to the occurrence of an adverse drug reaction (ADR). Data will be collected through the administration of a questionnaire and measurement of vital signs prior to the administration of tropicamide/phenylephrine 8 mg/50 mg/mL, and subsequently at 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours after administration, with the aim of establishing an association between these variables.
Inclusion: Patients who have authorized participation in the study by signing informed consent; Patients over 18 years of age; Any sex; Patients from the "Instituto de Oftalmología Conde de Valenciana, IAP., sede Centro" who have been scheduled for a surgical procedure; Patients for whom the administration of two drops of tropicamide/phenylephrine 8 mg/50 mg/mL is indicated; Patients that presents any type of disease.
Exclusion: Allergy to any component of the formulation.