The study of health state utility of diabetic retinopathy from EQ-5D-5L, Time trade off and HUI3

Not Applicable

Active, not recruiting

• Conditions: Quality of life - Health state utility- Visual acuity - Multicenter cross- sectional survey; Health state utility; Diabetic retinopathy; Cataract; Wet- age related macular degeneration

• Registration Number: TCTR20190831003
• Lead Sponsor: Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-31
• Study Completion: 2021-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Inclusion criteria for DR
1.Type 2 diabetes patient age> 18 years old
2.No other intraocular disease that effect functioning of vision such as primary open angle glaucoma , retinal vascular occlusion , hereditary retina disease , ocular inflammation , central serous chorioretinopathy, macular hole, rhegmatogenous retinal detachment or other disease that interfere vision except diabetic complications: DME, TRD, NVG and VH . ERM without macular hole is included in the study.
3.No cataract more than NS2+/PSC1+/CC2+
4.No history of Alzheimer’s disease, Dementia or poor mental health status or on current treatment of psychotic/antidepressant medication
5.No history of any ocular surgery within 3 months
6.Native Thai speaking

Inclusion criteria for cataract
1.Any cataract age> 18 years old
2.No other intraocular disease that effect functioning of vision such as primary open angle glaucoma , retinal vascular occlusion , hereditary retina disease , ocular inflammation , central serous chorioretinopathy, macular hole, diabetic retinopathy rhegmatogenous retinal detachment, wet-age related macular degeneration or any ocular condition that alter vision except from cataract.
3.No history of Alzheimer’s disease, Dementia or poor mental health status or on current treatment of psychotic/antidepressant medication
4.No history of any ocular surgery within 3 months
5.Native Thai speaking

Inclusion criteria for Wet age-related macular degeneration
1.Any wet AMD age> 18 years old
2.No other intraocular disease that effect functioning of vision such as primary open angle glaucoma , retinal vascular occlusion , hereditary retina disease , ocular inflammation , central serous chorioretinopathy, macular hole, diabetic retinopathy rhegmatogenous retinal มDME, TRD, NVG and VH .
3.No cataract more than NS2+/PSC1+/CC2+
4.No history of Alzheimer’s disease, Dementia or poor mental health status or on current treatment of psychotic/antidepressant medication
5.No history of any ocular surgery within 3 months
6.Native Thai speaking

Exclusion Criteria

Exclusion criteria for DR
1.Patient who is not willing to complete the interview or unwilling to answer the question
2.Dense posterior capsular opacity in pseudophakic patient that interfere visual acuity
3.Patient/respondents who indicated for not understand the task on a feasibility questionnaire
4.Patient/respondents who did not differentiate between any of different health states
5.Patient/respondents who did not trade off any time (non -trader)
6.Patient/respondents who use time for each task more than 150% of average time from pilot study

Exclusion criteria for cataract
1.Patient who is not willing to complete the interview or unwilling to answer the question
2.Patient/respondents who indicated for not understand the task on a feasibility questionnaire
3.Patient/respondents who did not differentiate between any of different health states
4.Patient/respondents who did not trade off any time (non -trader)
5.Patient/respondents who use time for each task more than 150% of average time from pilot study

Exclusion criteria for W AMD
1.Patient who is not willing to complete the interview or unwilling to answer the question
2.Patient/respondents who indicated for not understand the task on a feasibility questionnaire
3.Patient/respondents who did not differentiate between any of different health states
4.Patient/respondents who did not trade off any time (non -trader)
5.Patient/respondents who use time for each task more than 150% of average time from pilot study

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health state utility 1 day Time trade off survey

Secondary Outcome Measures

Name	Time	Method
Health state utility 1 day HUI3 survey, EQ-5D-5L survey,Visual acuity 1 day modified ETDRS chart ,Dermographic data 1 day interview,Eye examination 1 day Chart recored and imaging