The impact of topical mydriatic ophthalmic solutions on retinal vascular reactivity and blood flow.
Edmund Tsui, Mitra Sehi, Richard W F Cheng...
https://pubmed.ncbi.nlm.nih.gov/23701974Actively Recruiting
Age: 18Years +
All Genders
ID07178600
Characterization and Association of Clinical Determinants With the Occurrence of Adverse Drug Reactions Following the Administration of Tropicamide/Phenylephrine in Hospitalized Patients
Led by Instituto de Oftalmología Fundación Conde de Valenciana · Updated on 2025-09-17
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the relationship between clinical factors and the occurrence of adverse drug reactions in hospitalized patients who receive tropicamide/phenylephrine 8 mg/50 mg/mL. This study aims to identify which clinical determinants may increase the risk of these reactions and provide safety information for this commonly used ophthalmic drug combination. It also seeks to establish safety measures for patients undergoing eye examinations or surgery where these drugs are used. The study involves hospitalized patients scheduled for surgery who will receive two drops of tropicamide/phenylephrine 8 mg/50 mg/mL. Vital signs will be measured before administration and then at several time points afterward, including 5, 15, 30 minutes, and 1, 2, and 3 hours post-administration. Data will be collected using questionnaires and analyzed to find associations between clinical factors and adverse reactions. Participants will be monitored closely through vital sign checks and questionnaires during the study period. Researchers will evaluate adverse drug reactions and clinical determinants to understand their connection. The main outcome is to assess vital signs at set intervals following drug administration and identify any adverse reactions. The study is observational and aims to enhance the safety profile of this medication in hospitalized patients.
CONDITIONS
Brief Title
Clinical Determinants and Adverse Reactions to Tropicamide/Phenylephrine in Hospitalized Patients.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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, scheduled for a surgical procedure.
- Patients for whom two drops of tropicamide/phenylephrine 8 mg/50 mg/mL are indicated.
- Patients that present any type of disease.
You will not qualify if you...
- Allergy to any component of the formulation.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Single day
Participants receive ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL and have vital signs measured before and multiple times after administration to monitor for adverse drug reactions.
1 visit (in-person) with vital signs measured prior to administration and at 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, and 3 hours afterward
Trial Site Locations
Total: 1 location
1
Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro
Mexico City, Mexico Ciy, Mexico, 06800
Actively Recruiting
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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