Health-related quality of life, visual function and treatment satisfaction following intravitreal dexamethasone implant for diabetic macular edema

Ramu, Jayashree; Chatziralli, Irini; Yang, Ya-Ting; Menon, Geeta; Bailey, Clare; Eckstein, Michael; Hykin, Philip; Sivaprasad, Sobha

doi:10.2147/ppa.s132859

Cited by 10 publications

(6 citation statements)

References 27 publications

(33 reference statements)

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“…Sub-scale analysis prior to and following laser photocoagulation showed a statistically significant change in five of the 13 items of RetTSQ: overall satisfaction with current treatment, discomfort/pain, unpleasantness of treatment, patient influence on the treatment and received information about the treatment. According to Ramu et al the patients' perceived treatment satisfaction was based on their final VA status, while baseline VA and macular thickness were not found to affect RetTSQ scores [20]. Considering the statistically significant decline in the patients' post treatment visual acuity and the decrease of their TS score in our sample, it is not surprising that we found a similar result, in regard to their overall satisfaction with the treatment.…”

Section: Discussionsupporting

confidence: 70%

“…On the other hand, there is no comparable data from other studies that used the RetTSQ as we did, in patients with PDR treated with PRP. The fact that the RetTSQ has previously been employed in only a few studies [17,20] and has not been rigorously tested in more researches represents one of the main limitations of our study [25]. Further testing of RetTSQ is required to establish the usefulness of RetTSQ to measure patient satisfaction of different treatments.…”

Section: Discussionmentioning

confidence: 97%

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Vision-Related Quality of Life and Treatment Satisfaction Following Panretinal Photocoagulation in Diabetic Retinopathy—A Panel Study

et al. 2022

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Background and Objectives: The aim of the study was to evaluate vision-related quality of life (VR-QOL) and treatment satisfaction (TS) in patients with diabetic retinopathy treated with panretinal photocoagulation (PRP). Material and Methods: The panel study included 95 patients who underwent PRP for diabetic retinopathy. Eligible patients with no history of previous PRP were interviewer-administered the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) and Retinopathy Treatment Satisfaction Questionnaire (RetTSQ) beforehandand one month after the last session of laser application. The study was conducted between June 2017 and June 2019 at tertiary care center in Serbia, Belgrade. We assessed pre- to post-PRP values of the composite score and subscale scores of VFQ-25 and RetTSQ, using a paired samples t-test. Univariate logistic regression was used to analyze the relationship between binary outcomes and potential predictors. Multivariate regression included predictors from univariate analyses that were statistically significant. Results: The mean VFQ-25 composite score was 65.4 ± 17.4 before and 63.3 ± 19.5 after PRP (p = 0.045). Subscale analysis showed that two of the 11 items achieved a significant decrease after laser application (general vision and dependency). The mean RetTSQ score at baseline was 60.0 ± 11.8 and at the exit visit was 60.3 ± 12.3 (p = 0.858). Sub-scale analysis showed significant deterioration for five of the 13 items. Multivariate logistic regression found that significant predictor of VFQ-25 composite score reduction was fewer laser burns (p = 0.002) while significant predictor of RetTSQ total score reduction was presence of hyperlipidaemia (p = 0.021). Conclusion: The use of vision-related quality of life and treatment satisfaction questionnaires in conjunction with clinical examination, appears to provide a more comprehensive overview of an individual’s daily well-being following PRP. Laser treatment for diabetic retinopathy leads to deterioration of some of the patients’ perceived VR-QOL and TS. Health-care providers should inform patients about their treatment options and together decide which therapeutic method is best for them.

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Section: Discussionsupporting

confidence: 70%

Section: Discussionmentioning

confidence: 97%

Vision-Related Quality of Life and Treatment Satisfaction Following Panretinal Photocoagulation in Diabetic Retinopathy—A Panel Study

et al. 2022

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“…There are no thresholds for clinically meaningful change for the RetTSQ. 67 However, in the validation of the RetTSQ a three-point difference was observed between those with very good visual acuity and those in the category below (five-category visual acuity variable). 38 The quality-of-life change assessed using RetDQoL did not show any difference between arms ( Table 15).…”

Section: Secondary Outcomesmentioning

confidence: 99%

Intravitreal aflibercept compared with panretinal photocoagulation for proliferative diabetic retinopathy: the CLARITY non-inferiority RCT

et al. 2018

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Background Panretinal photocoagulation (PRP) has been the standard of care for patients with proliferative diabetic retinopathy (PDR) for the last 40 years. It prevents severe visual loss in PDR but is also associated with adverse effects on visual functions. Objectives The clinical efficacy and mechanistic evaluation of aflibercept for proliferative diabetic retinopathy (CLARITY) trial evaluated the clinical efficacy, mechanisms and cost-effectiveness of intravitreal aflibercept (Eylea®, Regeneron, Tarrytown, NY, USA/Bayer Pharma AG, Berlin, Germany therapy for PDR. Design A multicentre, prospective, individually randomised, single-masked, active-controlled trial with concurrent economic evaluation that tested the non-inferiority of intravitreal aflibercept versus standard care PRP at 52 weeks. A subset of the participants enrolled in a mechanistic evaluation substudy. Setting 22 UK NHS clinical sites. Participants Patients aged at least 18 years having either treatment-naive PDR or active retinal neovascularisation (NV) despite prior PRP requiring treatment and best corrected visual acuity (BCVA) of 54 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or better in the study eye were included. Eyes with evidence of macular oedema at baseline confirmed by central subfield thickness > 320 µm on spectral-domain optical coherence tomography were excluded. Intervention In the intervention arm, intravitreal aflibercept injections were given at baseline, 4 and 8 weeks and patients were subsequently reviewed every month and injected pro re nata based on the treatment response defined by degree of regression of retinal NV. In the comparator arm, PRP was completed in 2-weekly sessions and then supplemented if necessary at 8-weekly intervals. Main outcome measures The primary outcome was the mean change in BCVA at 52 weeks utilising a linear mixed-effects model incorporating data from both week 12 and week 52. Results A total of 232 participants (116 per arm) were recruited between August 2014 and November 2015. A total of 221 and 210 participants contributed to the intention-to-treat (ITT) model and per-protocol (PP) analysis, respectively. Economic evaluation was undertaken on 202 participants (101 per arm) with complete cost and outcome data. Aflibercept was non-inferior and superior to PRP in both the ITT population [mean BCVA difference 3.9 letters, 95% confidence interval (CI) 2.3 to 5.6 letters; p < 0.0001] and the PP population (difference 4.0 letters, 95% CI 2.4 to 5.7 letters; p < 0.0001). From a public sector multiagency perspective that covers health and social care services, treatment with aflibercept costs more in terms of total resource use (mean adjusted total additional cost per patient = £5475, bootstrapped 95% CI £5211 to £5750) than PRP over a 12-month follow-up period. There were a small number of important safety events in each arm. Patients were more satisfied with aflibercept than PRP. Limitations This study is limited to 1 year of follow-up. Conclusions At an additional cost, the study shows that intravitreal aflibercept is an effective alternative treatment option for PDR in the first year. Future work Future research is needed to evaluate the long-term benefits of aflibercept in comparison with PRP and other anti-vascular endothelial growth factor agents for this condition. Trial registration Current Controlled Trials ISRCTN32207582. Funding This project was funded by the National Institute for Health Research (NIHR) Efficacy and Mechanistic Evaluation programme, a Medical Research Council and NIHR partnership. Aflibercept was supplied by Bayer Plc (Reading, UK). The study was sponsored by NIHR Moorfields Biomedical Research Centre and supported by the UK Clinical Research Network. The research was supported by the NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and University College London Institute of Ophthalmology, the NIHR Moorfields Clinical Research Facility and the UK Clinical Reasearch Collaboration-registered King’s Clinical Trials Unit at King’s Health Partners, which is partly funded by the NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King’s College London.

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“…Current anti-VEGF treatments require frequent injections and monitoring, causing a significant burden on patients and healthcare systems, with a financial impact and reduction in patient quality of life. 128 In a 2017 report, Ramu et al 129 reported a statistically significant improvement in treatment satisfaction in patients with DME treated with dexamethasone intravitreal implants.…”

Section: Discussionmentioning

confidence: 99%

Saudi Arabia Guidelines for diabetic macular edema

Alqahtani

Hazzazi²,

Waheeb

et al. 2021

SMJ

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Diabetes mellitus (DM) and its complications are major public health burdens in Saudi Arabia. The prevalence of diabetic retinopathy (DR) is 19.7% and the prevalence of diabetic macular edema (DME) is 5.7% in Saudi Arabia. Diabetic macular edema is a vision-threatening complication of DR and a major cause of vision loss worldwide. Ocular treatments include retinal laser photocoagulation, anti-vascular endothelial growth factor (anti-VEGF) agents, intravitreal corticosteroids, and vitreoretinal surgery when necessary. The present consensus was developed as a part of the Saudi Retina Group’s efforts to generate Saudi guidelines and consensus for the management of DME, including recommendations for its diagnosis, treatment, and best practice. The experts’ panel stipulates that the treatment algorithm should be categorized according to the presence of central macula involvement. In patients with no central macular involvement, laser photocoagulation is recommended as the first-line option. Patients with central macular involvement and no recent history of cardiovascular (CVS) or cerebrovascular disorders can be offered anti-VEGF agents as the first-line option. In the case of non-responders (defined as an improvement of <20% in optical coherence tomography or a gain of fewer than 5 letters in vision), switching to another anti-VEGF agent or steroids should be considered after 3 injections. Within the class of steroids, dexamethasone implants are recommended as the first choice. In patients with a recent history of CVS events, the use of anti-VEGF agents is not recommended, regardless of their lens status. The experts’ panel recommends that a future study be conducted to provide a cut-off point for early switching to steroid implants in pseudo-phakic eyes.

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Health-related quality of life, visual function and treatment satisfaction following intravitreal dexamethasone implant for diabetic macular edema

Cited by 10 publications

References 27 publications

Vision-Related Quality of Life and Treatment Satisfaction Following Panretinal Photocoagulation in Diabetic Retinopathy—A Panel Study

Vision-Related Quality of Life and Treatment Satisfaction Following Panretinal Photocoagulation in Diabetic Retinopathy—A Panel Study

Intravitreal aflibercept compared with panretinal photocoagulation for proliferative diabetic retinopathy: the CLARITY non-inferiority RCT

Saudi Arabia Guidelines for diabetic macular edema

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