---
title: Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation
nct_id: NCT00120432
overall_status: COMPLETED
phase: PHASE3
sponsor: Khon Kaen University
study_type: INTERVENTIONAL
primary_condition: Eye Diseases
countries: Thailand
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00120432.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00120432"
ct_last_update_post_date: 2012-03-09
last_seen_at: "2026-05-12T07:25:00.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation

**NCT ID:** [NCT00120432](https://clinicaltrials.gov/study/NCT00120432)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 80
- **Lead Sponsor:** Khon Kaen University
- **Conditions:** Eye Diseases
- **Start Date:** 2004-12
- **Completion Date:** 2005-06
- **CT.gov Last Update:** 2012-03-09

## Brief Summary

The purpose of this study is to compare the efficacy on pupillary dilation between the single dose versus the three doses of 1% tropicamide with 10% phenylephrine for complete ocular examination.

## Detailed Description

To the best of the authors' knowledge, there have been no clinical trials using an appropriate regimen for pupillary dilation up until now. Therefore, the authors were interested to find out the most appropriate regimen for complete ocular examination, based on the finding that a pupil diameter of 6 mm or greater is adequate for indirect ophthalmoscopy. The authors hypothesize that a single dose of 1% tropicamide and 10% phenylephrine is adequate to complete the job and are conducting this prospective randomized clinical controlled trial to prove the hypothesis.

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* aged between 20 and 80 years old
* dark iris
* require binocular indirect ophthalmoscopy for complete ocular examination
* signed written consent forms

Exclusion Criteria:

* history of ocular trauma
* history of intraocular surgery
* history of laser treatment
* previous eye drop instillation that may affect pupillary dilation
* ocular diseases that may affect pupil size such as Horner's syndrome, Adies' pupil, glaucoma and uveitis
* history of diabetes mellitus, severe hypertension and cardiovascular diseases
```

## Arms

- **A** (ACTIVE_COMPARATOR) — single dose vs three doses of 1%tropicamide and 10%phenylephrine

## Interventions

- **1% tropicamide and 10% phenylephrine** (DRUG) — single dose vs three doses of 1%tropicamide and 10%phenylephrine

## Primary Outcomes

- **horizontal pupil diameter** _(time frame: 30 min)_

## Secondary Outcomes

- **systolic blood pressure** _(time frame: 30 min)_
- **diastolic blood pressure** _(time frame: 30 min)_
- **heart rate** _(time frame: 30 min)_
- **adverse drug reaction** _(time frame: 30 min)_

## Locations (1)

- Srinagarind Hospital, Khon Kaen, Changwat Khon Kaen, Thailand

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.srinagarind hospital|khon kaen|changwat khon kaen|thailand` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00120432.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00120432*  
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