An observational study in Adverse Drug Effect, Phenylephrine and Hypertension, sponsored by Instituto de Oftalmología Fundación Conde de Valenciana. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Instituto de Oftalmología Fundación Conde de Valenciana · Observational
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.
In the diagnostic approach of patients with ophthalmologic diseases, as well as for surgical purposes, the administration of mydriatic and cycloplegic drugs is indispensable. Among these, the combination of tropicamide and phenylephrine (TF) is commonly used. Studies evaluating the topical ocular administration of these medications have demonstrated an adequate risk-benefit balance; however, certain local and systemic safety aspects remain insufficiently evaluated.
Justification: This study will help identify the at-risk population (clinical determinants) prior to the administration of drugs such as TF, provide additional information regarding the safety profile of this drug at the 8 mg/50 mg/mL concentration, and propose measures to reduce the occurrence of adverse drug reactions (ADRs) in at-risk populations. It also aims to develop safety barriers that allow for safer administration of the medication. Moreover, this research provides a first approximation and establishes the basis for future studies that may compare different TF concentrations.
Hypothesis: There will be a positive association between clinical determinants and the occurrence of adverse drug reactions.
Research Question: Is there an association between the clinical determinants of hospitalized patients and the occurrence of adverse drug reactions following the administration of tropicamide/phenylephrine?
Objective: 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.
Materials and Methods:
An ambispective study will be conducted to identify ADRs associated with TF administration, as well as to characterize pathologies that may predispose patients to ADRs (clinical determinants, CD), through the use of a questionnaire, with the purpose of establishing an association between them.
Data Analysis:
Results will be analyzed using the Chi-square test for qualitative variables and the calculation of odds ratios (OR) with 95% confidence intervals. Quantitative variables will be analyzed using the Student's t-test for normally distributed data, or the Wilcoxon signed-rank test for data not normally distributed. Normality will be assessed with the Kolmogorov-Smirnov test (p > 0.05). The association between CDs and ADRs will be evaluated through logistic regression analysis
449 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 414 across 162 observational studies indexed under Drug-Related Side Effects and Adverse Reactions.
Browse Drug-Related Side Effects and Adverse Reactions studies →Instituto de Oftalmología Fundación Conde de Valenciana is the lead sponsor of 45 studies on the registry; 10 are open to participants now.
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Patients over 18 years of age who have been hospitalized to undergo a surgical procedure at the "Instituto de Oftalmología Conde de Valenciana, IAP".
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients over 18 years of age who have been hospitalized to undergo a surgical procedure and who received tropicamide/phenylephrine 8 mg/50 mg/mL at the Instituto de Oftalmologia 'Conde de Valenciana' IAP
Drug: Ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL.
Measurement of vital signs after ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL
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)
Time frame: Measurement of vital signs prior to the administration of tropicamide/phenylephrine 8 mg/50 mg/mL, and at 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, and 3 hours afterward.
To identify and characterize the clinical determinants of hospitalized patients receiving tropicamide/phenylephrine 8 mg/50 mg/mL at the Instituto de Oftalmología Conde de Valenciana
Identification of clinical determinants based on medical records review and patient interview.
Time frame: At enrollement
To actively identify adverse reactions to tropicamide/phenylephrine 8 mg/50 mg/mL.
To identify adverse drug reactions (ADRs) to tropicamide/phenylephrine 8 mg/50 mg/mL through a pharmacovigilance questionnaire administered to the patient and by measuring vital signs after administration.
Time frame: At enrollment Measurement of vital signs prior to the administration of tropicamide/phenylephrine 8 mg/50 mg/mL, and at 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, and 3 hours afterward.
Plan to share: No — The plan is to share the data after finishing the protocol
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Instituto de Oftalmología Fundación Conde de Valenciana