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OpenTrials
Completed

NCT Number: NCT02866734

Diabetic Retinopathy Screening in Private Practice

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, The University of Hong Kong, Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed to have diabetic mellitus
  • Able to give informed consent

Exclusion criteria

  • Pregnant women

Treatment and study plan

Free screening group

Other

The intervention provide Diabetic Retinopathy screening without charging a fee.

Pay screening group ($150)

Other

The intervention is charging HK$150 for the Diabetic Retinopathy screening.

Pay screening group ($300)

Other

The intervention is charging HK$300 for the Diabetic Retinopathy screening.

Primary outcomes

  1. The overall, & at different fee level, uptake (as a percentage of participants) of screening from those at-risk patients who attend private GP's

    Time frame: one year

Secondary outcomes

  1. 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

    Time frame: one year

  2. Prevalence of DR (overall, and for sight-threatening diabetic retinopathy) among diabetic patients in private primary care

    Time frame: one year

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Aug 15, 2016
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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