Diabetic RetinopathyNCT00500097
Diabetic Retinopathy and Diabetic Macular Edema Screening by Non-Physicians With Limited Training
A study testing Digital retina image, direct ophthalmoscopy and comprehensive eye exam in people with Diabetic Retinopathy, run by Ministry of Health, Thailand at 1 site in Thailand.
Trial summary
The purpose is to assess accuracy of digital retinal image interpretation by technicians and direct ophthalmoscopy by nurses for the determination of diabetic retinopathy severity and the presence of diabetic macular edema for the identification of referrals to ophthalmologists. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Digital retina image, direct ophthalmoscopy and comprehensive eye exam
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 840 participants
- Where
- 1 siteThailand
- Study dates
- May 2005to Jun 2006
- Phase
- Interventional
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diabetic patients defined by WHO criteria
- lived in the geographic area of participated hospitals
Who cannot join
- have contraindications for receiving mydriatic medications
- have ocular media not clear enough for making diagnosis by any of the screening equipment
- have other retina diseases precluded the diagnosis of diabetic retinopathy
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Ophthalmology, Rajavithi Hospital
Bangkok, 11120
About this study
The purpose is to assess accuracy of digital retinal image interpretation by technicians and direct ophthalmoscopy by nurses for the determination of diabetic retinopathy severity and the presence of diabetic macular edema for the identification of referrals to ophthalmologists. The results of both screening methods were compared with comprehensive eye examination by ophthalmologists.
Read the detailed description
Diabetic visual disabilities have increasingly become a global concern since a number of diabetic patients are expected to surge dramatically in the coming decade. Essential means to minimize this problem are detecting vision-threatening diabetic retinopathy early in the course of disease and timely interventions by ophthalmologists.
The American Diabetes Association had issued a guideline for the detection and recommended regular comprehensive eye examination as a preferred method. However, it is not likely that there will be ophthalmologists enough to comprehensively examine the surging number of diabetic patients. Other practical screening methods, such as an interpretation of digital retinal images or direct ophthalmoscopy employed by other health care providers, for identifying the retinopathy for referral to ophthalmologists, should minimize this problem.
- Conditions
- Diabetic Retinopathy
- Being tested
- Digital retina image, direct ophthalmoscopy, comprehensive eye exam
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital retina imageDevice
direct ophthalmoscopyDevice
comprehensive eye examProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, kappa coefficient
Measured: cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startMay 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Thailand
- Sponsor type
- Other government
- Investigators
- Paisan Ruamviboonsuk, MD, Principal investigator, Department of Ophthalmology, Rajavithi Hospital, Bangkok, Thailand 10400
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500097
- Sponsor's protocol ID
- 0321/1874
- Status last verified
- Jul 2007
- First submitted
- 11 Jul 2007
- Last updated
- 31 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Retinopathy and Diabetic Macular Edema Screening by Non-Physicians With Limited Training
- ClinicalTrials.gov ID
- NCT00500097
- Acronym / sponsor ID
- 0321/1874
- Conditions
- Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Ministry of Health, ThailandOther government
- Study start
- May 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 12 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.
The purpose is to assess accuracy of digital retinal image interpretation by technicians and direct ophthalmoscopy by nurses for the determination of diabetic retinopathy severity and the presence of diabetic macular edema for the identification of referrals to ophthalmologists. The results of both screening methods were compared with comprehensive eye examination by ophthalmologists.
Detailed description
Diabetic visual disabilities have increasingly become a global concern since a number of diabetic patients are expected to surge dramatically in the coming decade. Essential means to minimize this problem are detecting vision-threatening diabetic retinopathy early in the course of disease and timely interventions by ophthalmologists.
The American Diabetes Association had issued a guideline for the detection and recommended regular comprehensive eye examination as a preferred method. However, it is not likely that there will be ophthalmologists enough to comprehensively examine the surging number of diabetic patients. Other practical screening methods, such as an interpretation of digital retinal images or direct ophthalmoscopy employed by other health care providers, for identifying the retinopathy for referral to ophthalmologists, should minimize this problem.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- diabetic patients defined by WHO criteria
- lived in the geographic area of participated hospitals
Key exclusion criteria (3 listed)
- have contraindications for receiving mydriatic medications
- have ocular media not clear enough for making diagnosis by any of the screening equipment
- have other retina diseases precluded the diagnosis of diabetic retinopathy
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 |
|---|---|---|
| Digital retina image | Device | – |
| direct ophthalmoscopy | Device | – |
| comprehensive eye exam | Procedure or surgery | – |
Primary outcome
Sensitivity, specificity, kappa coefficient
Time frame: cross-sectional
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 31 Jul 2007.
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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.
Paisan Ruamviboonsuk, MD principal investigator
Department of Ophthalmology, Rajavithi Hospital, Bangkok, Thailand 10400
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital retina image, direct ophthalmoscopy and comprehensive eye exam in people with Diabetic Retinopathy, run by Ministry of Health, Thailand 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 2 inclusion and 3 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 31 Jul 2007. 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.
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?
Sensitivity, specificity, kappa coefficient (time frame: cross-sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2007.