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Uptake of Comprehensive Eye Examination Trial

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ClinicalTrials.gov Identifier: NCT01743781
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : January 6, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Glaucoma Diabetic Retinopathy Behavioral: video

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 459 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of Multimedia Education on Uptake of Comprehensive Eye Examination in Rural Southern China:A Randomized, Controlled Trial
Study Start Date : July 2013
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. The acceptance rate of comprehensive eye examination in both groups [ Time Frame: 1 day ]
    acceptance rate of comprehensive eye examination


Secondary Outcome Measures :
  1. knowledges of eye disease and attitude of eye examination [ Time Frame: 1 day ]
    knowledges of eye disease and attitude of eye examination


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥40 years who have never had a comprehensive eye examination

Exclusion Criteria:

  • inability to join informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743781


Locations
China, Guangdong
54 Xianlie Rd
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Orbis
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
Principal Investigator: Aihua Dan, MD Sun Yat-sen University,Zhongshan Ophthalmic Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Congdon Nathan, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01743781     History of Changes
Other Study ID Numbers: ZOC-CREST2
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: January 2014

Keywords provided by Congdon Nathan, Sun Yat-sen University:
comprehensive eye examination
acceptance
glaucoma
diabetic retinopathy

Additional relevant MeSH terms:
Glaucoma
Retinal Diseases
Diabetic Retinopathy
Ocular Hypertension
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases