Diabetes MellitusPhase 4NCT00501878
2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides
A Phase 4 study testing 2.5% or 10% phenylephrine in people with Diabetes Mellitus, run by Khon Kaen University at 1 site in Thailand.
Trial summary
To compare the clinical efficacy and systemic side effects between 2.5% and 10% phenylephrine for mydriasis in diabetic patient with darkly pigmented irides. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- 2.5% or 10% phenylephrine
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- May 2007to Jul 2007
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetic patients
Who cannot join
- history of intraocular surgery or laser treatment,
- any ocular diseases that might affect pupil size such as glaucoma,uveitis,Horner's syndrome, Adies' pupil,
- history of allergy to any drug used, and
- hypertension
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Srinagarind Hospital Eye Clinic
Khon Kaen, Changwat Khon Kaen, 40002
About this study
To compare the clinical efficacy and systemic side effects between 2.5% and 10% phenylephrine for mydriasis in diabetic patient with darkly pigmented irides.
Read the detailed description
One hundred patients with diabetes from Srinagarind Hospital Eye Clinic were enrolled and randomized into two groups by block randomization. In group I (50 patients), 1% tropicamide combined with 2.5% phenylephrine were administered to dilate pupil whereas 1% tropicamide combined with 10% phenylephrine were used in Group II (50 patients). Pupil diameter, blood pressure and heart rate were measured before and after eye drop instillations.
- Conditions
- Diabetes Mellitus
- Being tested
- 2.5% or 10% phenylephrine
- Keywords
- phenylephrine, mydriasis, diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Mydriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.5% or 10% phenylephrineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil diameters were measured.
Measured: before and after phenylephrine eye drop instillations
Secondary outcomes (1)
blood pressure and heart rate were measured
Measured: before and after phenylephrine eye drop instillations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startMay 2007
- Study completionJul 2007
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 Diabetes MellitusStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 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
- NCT00501878
- Sponsor's protocol ID
- I50138
- Other IDs
- HE490619
- Status last verified
- Mar 2012
- First submitted
- 13 Jul 2007
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Suwan-Apichon O, Ratanapakorn T, Panjaphongse R, Sinawat S, Sanguansak T, Yospaiboon Y. 2.5% and 10% phenylephrine for mydriasis in diabetic patients with darkly pigmented irides. J Med Assoc Thai. 2010 Apr;93(4):467-73.
PubMed 20462091
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
- 2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides
- ClinicalTrials.gov ID
- NCT00501878
- Acronym / sponsor ID
- I50138
- Conditions
- Diabetes Mellitus
- Keywords
- phenylephrine, mydriasis, diabetes mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- May 2007
- Study completion
- Jul 2007 (actual)
- First posted
- 16 Jul 2007 (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.
To compare the clinical efficacy and systemic side effects between 2.5% and 10% phenylephrine for mydriasis in diabetic patient with darkly pigmented irides.
Detailed description
One hundred patients with diabetes from Srinagarind Hospital Eye Clinic were enrolled and randomized into two groups by block randomization. In group I (50 patients), 1% tropicamide combined with 2.5% phenylephrine were administered to dilate pupil whereas 1% tropicamide combined with 10% phenylephrine were used in Group II (50 patients). Pupil diameter, blood pressure and heart rate were measured before and after eye drop instillations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diabetic patients
Key exclusion criteria (4 listed)
- history of intraocular surgery or laser treatment,
- any ocular diseases that might affect pupil size such as glaucoma,uveitis,Horner's syndrome, Adies' pupil,
- history of allergy to any drug used, and
- hypertension
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 |
|---|---|---|
| 2.5% or 10% phenylephrine | Drug | – |
Primary outcome
Pupil diameters were measured.
Time frame: before and after phenylephrine eye drop instillations
1 secondary outcome
blood pressure and heart rate were measured
Time frame: before and after phenylephrine eye drop instillations
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 20462091Suwan-Apichon O, Ratanapakorn T, Panjaphongse R, Sinawat S, Sanguansak T, Yospaiboon Y. 2.5% and 10% phenylephrine for mydriasis in diabetic patients with darkly pigmented irides. J Med Assoc Thai. 2010 Apr;93(4):467-73.
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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 4 study testing 2.5% or 10% phenylephrine in people with Diabetes Mellitus, 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 1 inclusion and 4 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Pupil diameters were measured. (time frame: before and after phenylephrine eye drop instillations). 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 NCT00501878, 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.