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Patient-reported outcomes and visual acuity after 12 months of anti-VEGF-treatment for sight-threatening diabetic macular edema in a real world setting
Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Uppsala universitet.ORCID iD: 0000-0001-7721-8794
Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing.ORCID iD: 0000-0002-5892-9897
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2016 (English)In: Diabetes Research and Clinical Practice, ISSN 0168-8227, E-ISSN 1872-8227, Vol. 121, p. 157-165Article in journal (Refereed) Published
Abstract [en]

Aims

To examine objective visual acuity measured with ETDRS, retinal thickness (OCT), patient reported outcome and describe levels of glycated hemoglobin and its association with the effects on visual acuity in patients treated with anti-VEGF for visual impairment due to diabetic macular edema (DME) during 12 months in a real world setting.

Methods

In this cross-sectional study, 58 patients (29 females and 29 males; mean age, 68 years) with type 1 and type 2 diabetes diagnosed with DME were included. Medical data and two questionnaires were collected; an eye-specific (NEI VFQ-25) and a generic health-related quality of life questionnaire (SF-36) were used.

Results

The total patient group had significantly improved visual acuity and reduced retinal thickness at 4 months and remains at 12 months follow up. Thirty patients had significantly improved visual acuity, and 27 patients had no improved visual acuity at 12 months. The patients with improved visual acuity had significantly improved scores for NEI VFQ-25 subscales including general health, general vision, near activities, distance activities, and composite score, but no significant changes in scores were found in the group without improvements in visual acuity.

Conclusions

Our study revealed that anti-VEGF treatment improved visual acuity and central retinal thickness as well as patient-reported outcome in real world 12 months after treatment start.

Place, publisher, year, edition, pages
Elsevier, 2016. Vol. 121, p. 157-165
Keywords [en]
Patient-reported measurements; Diabetic macular edema; Anti-VEGF treatment; Visual function
National Category
Endocrinology and Diabetes
Research subject
Health and Welfare
Identifiers
URN: urn:nbn:se:du-23260DOI: 10.1016/j.diabres.2016.09.015ISI: 000390460100020PubMedID: 27718374OAI: oai:DiVA.org:du-23260DiVA, id: diva2:1037379
Available from: 2016-10-14 Created: 2016-10-14 Last updated: 2020-05-11Bibliographically approved
In thesis
1. Patient-reported and medical outcomes in patients treated for diabetic macular edema: A real-world longitudinal study
Open this publication in new window or tab >>Patient-reported and medical outcomes in patients treated for diabetic macular edema: A real-world longitudinal study
2020 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Background Diabetes mellitus can lead to complications, when the complication affects the eyes it is called retinopathy. This can affect the macula and lead to severe loss of vision, diabetic macular edema (DME). This condition has traditionally been treated with laser. However, in 2011, anti-vascular endothelial growth factor (anti-VEGF) injections in the eye were approved as a treatment for diabetic macular edema, and started to be used in eye clinics.

Aim The overall aim of this thesis was to describe patient-reported outcomes and medical outcomes (PRO) in people treated for diabetic macular edema in a real-world setting in a long-time follow-up study in Sweden.

Methods Participants were enrolled at two eye clinics at two county hospitals in Sweden between 2012 and 2014. Patient-reported outcomes were measured using a vision-specific questionnaire, the 25-question National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and a generic questionnaire, the Short Form-36 Health Survey (SF-36). Completed questionnaires, medical data such as visual acuity (EDRS), macula swelling (OCT) and social background characteristics were collected before treatment start, at one-year and four-year follow up points. The data was analyzed, descriptive statistics developed and comparative analyses were performed. Interviews were performed before treatment start and were analyzed using qualitative content analysis.

Results A total of 59 participants were included at baseline. The mean age was 69 years, with an equal gender distribution. At baseline, the participants scored a low general health with the vision-specific questionnaire. In total, 21 participants were interviewed, and a theme emerged of ‘being at a crossroads and a crucial phase in life with an uncertain outcome’. The participants expressed thoughts and concerns at different levels, including practical concerns about the treatment procedure and more existential thoughts about hope for improved visual acuity or fear of deterioration. The results at the one-year follow up showed that 30 patients had improved visual acuity and reported an improvement in several subscales in the NEI VFQ-25. The remaining 27 participants had no improvement in visual acuity or in the vision specific questionnaire. The four-year follow-up involved 37 people, and the result showed significant improvement in subjective near-vision activities and improved distance visual acuity.

Conclusion: Before treatment, the participants reported low general health and expressed concerns about the injection treatment and their vision. One year after treatment started, the results showed significant improvement in several NEI VFQ-25 subscales, decreased macula swelling and improved visual acuity. These positive results remained at the four-year follow-up point.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2020. p. 68
Keywords
Diabetes mellitus, Patient-reported outcomes, Retinopathy, Macular edema, Anti-VEGF treatment
National Category
Endocrinology and Diabetes
Research subject
Health and Welfare
Identifiers
urn:nbn:se:du-32652 (URN)978-91-513-0896-8 (ISBN)
Public defence
2020-04-28, Aula Gunnesalen, Ingång 10, Psykiatrins hus. Akademiska sjukhuset Uppsala., 13:00 (Swedish)
Opponent
Supervisors
Available from: 2020-05-11 Created: 2020-05-11 Last updated: 2020-05-11Bibliographically approved

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Granström, ThereseForsman, HenriettaLeksell, Janeth

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