GlaucomaNCT01743781
Uptake of Comprehensive Eye Examination Trial
A study testing video in people with Glaucoma and Diabetic Retinopathy, run by Sun Yat-sen University at 1 site in China.
Trial summary
1. To evaluate a educational intervention promoting acceptance of comprehensive eye examination in rural Guangdong. 2. To evaluate the impact of acceptance of comprehensive eye examination in rural Guangdong. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Glaucoma, Diabetic Retinopathy
- What is being tested?
- video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 459 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Sep 2013
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥40 years who have never had a comprehensive eye examination
Who cannot join
- inability to join informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Multimedia Education on Uptake of Comprehensive Eye Examination in Rural Southern China:A Randomized, Controlled Trial
- To evaluate a educational intervention promoting acceptance of comprehensive eye examination in rural Guangdong.
- To evaluate the impact of acceptance of comprehensive eye examination in rural Guangdong.
Read the detailed description
A comprehensive eye examination includes visual acuity, slitlamp exam, pupil exam, intraocular pressure, gonioscope lens and 90D lens with slitlamp exam fundus. A number of eye diseases are irreversible at on early stage. Both glaucoma and diabetic retinopathy(DR)are frequently asymptomatic until significant, often-irreversible, damage to the vision has already occurred. It has been estimated that only 10% of persons in India with glaucoma are diagnosed, and the Handan Eye Survey reports that only 10% of persons with diabetes in rural areas of China have received diabetic eye care. In order to deliver effective care for DR and glaucoma in areas with limited resources, education of patients and interventions to promote compliance among patients will both be needed.
- Conditions
- Glaucoma, Diabetic Retinopathy
- Being tested
- video
- Keywords
- comprehensive eye examination, acceptance, glaucoma, diabetic retinopathy
- Medical subject headings
- Glaucoma, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videoBehavioural
view a 10-minute informational video about comprehensive eye examination
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | view a 10-minute informational video about comprehensive eye examination Receives: Behavioral: video |
| control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The acceptance rate of comprehensive eye examination in both groups
acceptance rate of comprehensive eye examination
Measured: 1 day
Secondary outcomes (1)
knowledges of eye disease and attitude of eye examination
knowledges of eye disease and attitude of eye examination
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionSep 2013
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 GlaucomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Orbis, The World Diabetes Foundation
- Responsible party
- Principal investigator, Congdon Nathan, Sun Yat-sen University
- Investigators
- Nathan Congdon, MD,MPH, Principal investigator, Sun yat-sen university, Zhongshan Ophthalmic CenterMingguang He, MD,PHD, Principal investigator, Sun Yat-sen University,Zhongshan Ophthalmic CenterAihua Dan, MD, Principal investigator, Sun Yat-sen University,Zhongshan Ophthalmic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743781
- Sponsor's protocol ID
- ZOC-CREST2
- Status last verified
- Jan 2014
- First submitted
- 21 Nov 2012
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dan A, Raubvogel G, Chen T, Ye T, Jin L, Xiao B, Sanchez A, Congdon N. The Impact of Multimedia Education on Uptake of Comprehensive Eye Examinations in Rural China: A Randomized, Controlled Trial. Ophthalmic Epidemiol. 2015;22(4):283-90. doi: 10.3109/09286586.2015.1056812.
PubMed 26218111
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Multimedia Education on Uptake of Comprehensive Eye Examination in Rural Southern China:A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01743781
- Acronym / sponsor ID
- ZOC-CREST2
- Conditions
- Glaucoma, Diabetic Retinopathy
- Keywords
- comprehensive eye examination, acceptance, glaucoma, diabetic retinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Orbis, The World Diabetes Foundation
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 6 Dec 2012 (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 evaluate a educational intervention promoting acceptance of comprehensive eye examination in rural Guangdong.
- To evaluate the impact of acceptance of comprehensive eye examination in rural Guangdong.
Detailed description
A comprehensive eye examination includes visual acuity, slitlamp exam, pupil exam, intraocular pressure, gonioscope lens and 90D lens with slitlamp exam fundus. A number of eye diseases are irreversible at on early stage. Both glaucoma and diabetic retinopathy(DR)are frequently asymptomatic until significant, often-irreversible, damage to the vision has already occurred. It has been estimated that only 10% of persons in India with glaucoma are diagnosed, and the Handan Eye Survey reports that only 10% of persons with diabetes in rural areas of China have received diabetic eye care. In order to deliver effective care for DR and glaucoma in areas with limited resources, education of patients and interventions to promote compliance among patients will both be needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: videoview a 10-minute informational video about comprehensive eye examination |
| control group | No intervention | –No intervention |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age ≥40 years who have never had a comprehensive eye examination
Key exclusion criteria (1 listed)
- inability to join informed consent
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 |
|---|---|---|
| videoview a 10-minute informational video about comprehensive eye examination | Behavioural | intervention group |
Primary outcome
The acceptance rate of comprehensive eye examination in both groups
Time frame: 1 day
acceptance rate of comprehensive eye examination
1 secondary outcome
knowledges of eye disease and attitude of eye examination
Time frame: 1 day
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 6 Jan 2014.
- Derived from this study: PubMed 26218111Dan A, Raubvogel G, Chen T, Ye T, Jin L, Xiao B, Sanchez A, Congdon N. The Impact of Multimedia Education on Uptake of Comprehensive Eye Examinations in Rural China: A Randomized, Controlled Trial. Ophthalmic Epidemiol. 2015;22(4):283-90. doi: 10.3109/09286586.2015.1056812.
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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.
Nathan Congdon, MD,MPH principal investigator
Sun yat-sen university, Zhongshan Ophthalmic Center
Mingguang He, MD,PHD principal investigator
Sun Yat-sen University,Zhongshan Ophthalmic Center
Aihua Dan, MD principal investigator
Sun Yat-sen University,Zhongshan Ophthalmic Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video in people with Glaucoma and Diabetic Retinopathy, run by Sun Yat-sen University at 1 site in China.
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 1 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 6 Jan 2014. 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 China. 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?
The acceptance rate of comprehensive eye examination in both groups (time frame: 1 day). 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 NCT01743781, 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 6 Jan 2014.