Uptake of Comprehensive Eye Examination Trial

This study has been completed.
Sponsor:
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: January 3, 2014
Last verified: January 2014
  Purpose
  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 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 Southern China:A Randomized, Controlled Trial

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 day ] [ 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 day ] [ Designated as safety issue: No ]
    knowledges of eye disease and attitude of eye examination


Enrollment: 459
Study Start Date: July 2013
Study Completion Date: September 2013
Primary Completion Date: September 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:

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.

  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 have never had a comprehensive eye examination

Exclusion Criteria:

  • inability to join informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743781

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

No publications provided

Responsible Party: Congdon Nathan, Professor, 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: January 3, 2014
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 April 15, 2014