RecruitingNCT07178600

Clinical Determinants and Adverse Reactions to Tropicamide/Phenylephrine in Hospitalized Patients.

Characterization and Association of Clinical Determinants With the Occurrence of Adverse Drug Reactions Following the Administration of Tropicamide/Phenylephrine in Hospitalized Patients.


Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Enrollment

1,000 participants

Start Date

Sep 2, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining what factors — such as age, existing health conditions, and medications — predict who will have an adverse reaction to eye drops containing tropicamide and phenylephrine, which are routinely used to dilate the pupils before eye surgery. **You may be eligible if...** - You are older than 18 years - You have signed the informed consent form - You are a patient at the Instituto de Oftalmología Conde de Valenciana in Mexico City and are scheduled for a surgical procedure - Your doctor has prescribed two drops of tropicamide/phenylephrine (8 mg/50 mg/mL) for pupil dilation - You have any type of underlying medical condition **You may NOT be eligible if...** - You have a known allergy to any component of the eye drop formulation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOphthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL.

Measurement of vital signs after ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL


Locations(1)

Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro

Mexico City, Mexico Ciy, Mexico

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NCT07178600


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