Uptake of Comprehensive Eye Examination Trial
This study is not yet open for participant recruitment.
Verified April 2013 by Sun Yat-sen University
Sponsor:
Sun Yat-sen University
Collaborators:
ORBIS international
The World Diabetes Foundation
Information provided by (Responsible Party):
Congdon Nathan, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01743781
First received: November 21, 2012
Last updated: April 11, 2013
Last verified: April 2013
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Purpose
- To evaluate an educational intervention promoting acceptance of comprehensive eye examination in rural Guangdong.
- To evaluate the impact of acceptance of comprehensive eye examination in rural Guangdong.
| Condition | Intervention |
|---|---|
|
Glaucoma Diabetic Retinopathy |
Behavioral: video |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | The Impact of Multimedia Education on Uptake of Comprehensive Eye Examination in Rural Guangdong |
Resource links provided by NLM:
Further study details as provided by Sun Yat-sen University:
Primary Outcome Measures:
- The acceptance rate of comprehensive eye examination in both groups [ Time Frame: 1 week after in hospital eye clinic ] [ Designated as safety issue: No ]acceptance rate of comprehensive eye examination
Secondary Outcome Measures:
- knowledges of eye disease and attitude of eye examination [ Time Frame: 1 week after in hospital eye clinic ] [ Designated as safety issue: No ]knowledges of eye disease and attitude of eye examination
| Estimated Enrollment: | 480 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: intervention group
view a 10-minute informational video about comprehensive eye examination
|
Behavioral: video
view a 10-minute informational video about comprehensive eye examination
|
|
No Intervention: control group
No intervention
|
Detailed Description:
Comprehensive eye examination including visual acuity, slitlamp exam, pupil exam, goldmann intraocular pressure, gonioscope lens and 90D lens with slitlamp exam fundus. A great many of eye diseases are irreversible in 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 eye care providers and interventions to promote compliance among patients will both be needed.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age ≥40 years who never have comprehensive eye examination
Exclusion Criteria:
- severe psychotic disorders and dysgnosia patients
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743781
Contacts
| Contact: Nathan Congdon, MD,MPH | 020-87682342 | ncongdon1@gmail.com |
| Contact: Mingguang He, MD,PHD | 020-87682342 | mingguang_he@yahoo.com |
Locations
| China, Guangdong | |
| 54 Xianlie Rd | Not yet recruiting |
| Guangzhou, Guangdong, China, 510060 | |
| Contact: Nathan Congdon, MD, MPH +86-020-87330341 ncongdon1@gmail.com | |
| Principal Investigator: Nathan Congdon, MD,MPH | |
| Principal Investigator: Aihua Dan, MD | |
Sponsors and Collaborators
Sun Yat-sen University
ORBIS international
The World Diabetes Foundation
Investigators
| Principal Investigator: | Nathan Congdon, MD,MPH | Sun yat-sen university, Zhongshan Ophthalmic Center |
| Principal Investigator: | Mingguang He, MD,PHD | Sun Yat-sen University,Zhongshan Ophthalmic Center |
More Information
No publications provided
| Responsible Party: | Congdon Nathan, Principal Investigator, Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT01743781 History of Changes |
| Other Study ID Numbers: | ZOC-CREST2 |
| Study First Received: | November 21, 2012 |
| Last Updated: | April 11, 2013 |
| Health Authority: | China: Ministry of Science and Technology |
Keywords provided by Sun Yat-sen University:
|
comprehensive eye examination acceptance glaucoma diabetic retinopathy |
Additional relevant MeSH terms:
|
Diabetic Retinopathy Glaucoma Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases |
Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Ocular Hypertension |
ClinicalTrials.gov processed this record on May 16, 2013