Uptake of Comprehensive Eye Examination Trial

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01743781
• Collaborator: Orbis (Other), The World Diabetes Foundation (Other)
• Enrollment: 459
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 225.3

Study Details

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	Phase
Glaucoma; Diabetic Retinopathy	Behavioral: video	N/A

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
• 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: Jul 1, 2013
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

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 [1 day]

   acceptance rate of comprehensive eye examination

Secondary Outcome Measures

1. knowledges of eye disease and attitude of eye examination [1 day]

   knowledges of eye disease and attitude of eye examination

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• inability to join informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Congdon Nathan, Professor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT01743781
• Other Study ID Numbers: ZOC-CREST2
• First Posted: Dec 6, 2012
• Last Update Posted: Jan 6, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Congdon Nathan, Professor, Sun Yat-sen University: comprehensive eye examination; acceptance; glaucoma; diabetic retinopathy
• Additional relevant MeSH terms: Glaucoma; Retinal Diseases; Diabetic Retinopathy

Study Results

No Results Posted as of Jan 6, 2014