Eye DiseasesPhase 3NCT00120432
Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation
A Phase 3 study testing 1% tropicamide and 10% phenylephrine in people with Eye Diseases, run by Khon Kaen University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Eye Diseases
- What is being tested?
- 1% tropicamide and 10% phenylephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2004to Jun 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 20 and 80 years old
- dark iris
- require binocular indirect ophthalmoscopy for complete ocular examination
- signed written consent forms
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Eye Diseases
- Being tested
- 1% tropicamide and 10% phenylephrine
- Keywords
- single dose, mydriatic drug, pupillary dilation
- Medical subject headings
- Eye Diseases, Mydriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% tropicamide and 10% phenylephrineDrug
single dose vs three doses of 1%tropicamide and 10%phenylephrine
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | single dose vs three doses of 1%tropicamide and 10%phenylephrine Receives: Drug: 1% tropicamide and 10% phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
horizontal pupil diameter
Measured: 30 min
Secondary outcomes (4)
systolic blood pressure
Measured: 30 min
diastolic blood pressure
Measured: 30 min
heart rate
Measured: 30 min
adverse drug reaction
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2005 (estimated)
- Study startDec 2004
- Study completionJun 2005
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 Eye DiseasesStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yosanan Yospaiboon, Khon Kaen University
- Investigators
- Yosanan Yospaiboon, M.D., Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120432
- Sponsor's protocol ID
- HE461104
- Status last verified
- Mar 2012
- First submitted
- 11 Jul 2005
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ratanapakorn T, Yospaiboon Y, Chaisrisawadsuk N. Single dose of 1% tropicamide and 10% phenylephrine for pupil dilation. J Med Assoc Thai. 2006 Nov;89(11):1934-9.
PubMed 17205877
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation
- ClinicalTrials.gov ID
- NCT00120432
- Acronym / sponsor ID
- HE461104
- Conditions
- Eye Diseases
- Keywords
- single dose, mydriatic drug, pupillary dilation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Dec 2004
- Study completion
- Jun 2005 (actual)
- First posted
- 18 Jul 2005 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: 1% tropicamide and 10% phenylephrinesingle dose vs three doses of 1%tropicamide and 10%phenylephrine |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged between 20 and 80 years old
- dark iris
- require binocular indirect ophthalmoscopy for complete ocular examination
- signed written consent forms
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| 1% tropicamide and 10% phenylephrinesingle dose vs three doses of 1%tropicamide and 10%phenylephrine | Drug | A |
Primary outcome
horizontal pupil diameter
Time frame: 30 min
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
- Results publication: PubMed 17205877Ratanapakorn T, Yospaiboon Y, Chaisrisawadsuk N. Single dose of 1% tropicamide and 10% phenylephrine for pupil dilation. J Med Assoc Thai. 2006 Nov;89(11):1934-9.
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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. This study is not recruiting at the moment.
Yosanan Yospaiboon, M.D. principal investigator
Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 1% tropicamide and 10% phenylephrine in people with Eye Diseases, run by Khon Kaen University at 1 site in Thailand.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 9 Mar 2012. 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 Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
horizontal pupil diameter (time frame: 30 min). 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 NCT00120432, 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 9 Mar 2012.