Adverse Drug EffectRAM-TF-IOCVNCT07178600
Clinical Determinants and Adverse Reactions to Tropicamide/Phenylephrine in Hospitalized Patients.
An observational study of Adverse Drug Effect and Phenylephrine, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Drug Effect, Phenylephrine, Hypertension
- What is being tested?
- Ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL.
- How many people
- 1,000 participants
- Where
- 1 siteMexico
- Study dates
- 2 Sep 2023to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age who have been hospitalized to undergo a surgical procedure at the "Instituto de Oftalmología Conde de Valenciana, IAP".
Who may be able to join
- 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
Who cannot join
- Allergy to any component of the formulation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro
Mexico City, Mexico Ciy, 06800
Mitzi D Vera Sánchez, physician, (55) 54421700 ext. 3749, mitzi.vera@condeinvestigacion.org
Lorenzo Islas Vázquez, PhD. Biologic Sciences, (55) 54421700 ext. 3749, lorenzo.islas@institutodeoftalmologia.org
About this study
Official title: 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.
Read the detailed description
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
- Conditions
- Adverse Drug Effect, Phenylephrine, Hypertension, Cardiovascular Complication, Ophthalmology, Ocular Discomfort
- Being tested
- Ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL.
- Keywords
- Adverse Drug Effect, Tropicamide/phenylefrine, Tropicamide, Phenylefrine, Cardiovascular complications, Hypertension, Ophthalmology, Ocular discomfort
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL.Drug
Measurement of vital signs after ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized patients who received tropicamide/phenylephrine 8 mg/50 mg/mL. | 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 Receives: Drug: Ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start2 Sep 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María C. Jiménez Martínez, Instituto de Oftalmología Fundación Conde de Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178600
- Sponsor's protocol ID
- CEI-2023/09/02
- Other IDs
- CB-042-2023, CI-042-2023
- Acronym
- RAM-TF-IOCV
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The plan is to share the data after finishing the protocol
Publications
Tsui E, Sehi M, Cheng RW, Wan J, Wong T, Dorner S, Fisher JA, Hudson C. The impact of topical mydriatic ophthalmic solutions on retinal vascular reactivity and blood flow. Exp Eye Res. 2013 Jul;112:134-8. doi: 10.1016/j.exer.2013.05.005. Epub 2013 May 21.
PubMed 23701974
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Association of Clinical Determinants With the Occurrence of Adverse Drug Reactions Following the Administration of Tropicamide/Phenylephrine in Hospitalized Patients.
- ClinicalTrials.gov ID
- NCT07178600
- Acronym / sponsor ID
- RAM-TF-IOCV / CEI-2023/09/02
- Conditions
- Adverse Drug Effect, Phenylephrine, Hypertension, Cardiovascular Complication, Ophthalmology, Ocular Discomfort
- Keywords
- Adverse Drug Effect, Tropicamide/phenylefrine, Tropicamide, Phenylefrine, Cardiovascular complications, Hypertension, Ophthalmology, Ocular discomfort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 2 Sep 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized patients who received tropicamide/phenylephrine 8 mg/50 mg/mL. | – | Drug: Ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL.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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age who have been hospitalized to undergo a surgical procedure at the "Instituto de Oftalmología Conde de Valenciana, IAP".
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Allergy to any component of the formulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Hospitalized patients who received tropicamide/phenylephrine 8 mg/50 mg/mL. |
Primary outcome
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.
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.
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)
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
Time frame: At enrollement
Identification of clinical determinants based on medical records review and patient interview.
To actively identify adverse reactions to tropicamide/phenylephrine 8 mg/50 mg/mL.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Background: PubMed 23701974Tsui E, Sehi M, Cheng RW, Wan J, Wong T, Dorner S, Fisher JA, Hudson C. The impact of topical mydriatic ophthalmic solutions on retinal vascular reactivity and blood flow. Exp Eye Res. 2013 Jul;112:134-8. doi: 10.1016/j.exer.2013.05.005. Epub 2013 May 21.
- Individual participant dataSharing planned: No. The plan is to share the data after finishing the protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro
Mexico City, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Drug Effect and Phenylephrine, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07178600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.