Diabetic Retinopathy Screening in Private Practice

Diabetic Retinopathy Clinical Trial

Official title:

The Feasibility of Screening for Diabetic Retinopathy in Private Practice Hong Kong

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866734
• Other study ID #: 12133951
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: June 1, 2018

Study information

• Verified date: October 2018
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction: Diabetic mellitus (DM) is a prevalent disease in Hong Kong (HK) and diabetic retinopathy (DR) is one of the most common complications of DM. Screening for DR is a cost-effective method to identify patients who are at risk of vision loss so that timely treatment can be provided to patients. In Hong Kong, the Hospital Authority has recently set up screening services (RAMP) in the government outpatient clinics and all DM patients attending these clinics will be screened at least once every two years and some every six months, according to their individual risks. However, those diabetic patients who attend the private sector for their primary care may not have access to this service.

Aim: This study from the University of Hong Kong aims to determine the characteristics of a sustainable approach to setting up an effective and quality-controlled screening service for DR in the private primary care sector of Hong Kong and to estimate the potential benefit to be gained in terms of impact on avoidable vision loss, costs of care and potential for further development of this model in chronic disease care.

Methods:A screening centre is being set up and a randomised study carried out in which screening will be offered at three different fee levels to subjects recruited by their general practitioner (GP). The following data will be collected (a) willingness to attend screening at the different fee levels (b) screening findings in terms of DR and other eye diseases (c) risk factors and other characteristics of those screened and unscreened. The information will allow us to estimate the level of fee which best combines effectiveness with sustainability in the longer term.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: June 1, 2018
• Est. primary completion date: December 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed to have diabetic mellitus

• Able to give informed consent

Exclusion Criteria:

• Pregnant women

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Other:
• Free screening group
The intervention provide Diabetic Retinopathy screening without charging a fee.
• Pay screening group ($150)
The intervention is charging HK$150 for the Diabetic Retinopathy screening.
• Pay screening group ($300)
The intervention is charging HK$300 for the Diabetic Retinopathy screening.

Locations

Country	Name	City	State
Hong Kong	Department of Ophthalmology, The University of Hong Kong, Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall, & at different fee level, uptake (as a percentage of participants) of screening from those at-risk patients who attend private GP's		one year
Secondary	Percentage of participants with diabetes who are only under the care of a private GP, or also attend specialist service, and have had access to DR screening		one year
Secondary	Prevalence of DR (overall, and for sight-threatening diabetic retinopathy) among diabetic patients in private primary care		one year