Changes in vision related quality of life in patients with diabetic macular edema: Ranibizumab or laser treatment?

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Abstract

Purpose

To compare the changes in vision related quality of life (VR-QoL) in patients with diabetic macular edema (DME) undergoing intravitreal ranibizumab (IVR) injection or focal/grid laser.

Material and methods

In this prospective study, 70 patients with clinically significant macular edema (CSME) were randomized to undergo IVR injection (n = 35) and focal/grid laser (n = 35). If necessary, the laser or ranibizumab injections were repeated. Distance and near visual acuities, central retinal thickness (CRT) and The 25-item Visual Function Questionnaire (VFQ-25) were used to measure the effectiveness of treatments and VR-QoL before and after 6 months following IVR or laser treatment.

Results

The demographic and clinical findings before the treatments were similar in both main groups. The improvements in distance and near visual acuities were higher in IVR group than the laser group (p < 0.01). The reduction in CRT in IVR group was higher than that in laser treatment group (p < 0.01). In both groups, the VFQ-25 composite score tended to improve from baseline to 6 months. And at 6th month, the changes in composite score were significantly higher in IVR group than in laser group (p < 0.05). The improvements in overall composite scores were 6.3 points for the IVR group compared with 3.0 points in the laser group. Patients treated with IVR and laser had large improvements in composite scores, general vision, near and distance visual acuities in VFQ-25 at 6 months, in comparison with baseline scores, and also mental health subscale in IVR group.

Conclusion

Our study revealed that IVR improved not only visual acuity or CRT, but also vision related quality of life more than laser treatment in DME. And these patient-reported outcomes may play an important role in the treatment choice in DME for clinicians.

Introduction

Diabetes mellitus is the major systemic cause of blindness in the world. The major risk factor for severe reduction of vision in diabetic patients is macular edema resulting from increased vasopermeability and leakage of fluid into the retinal tissue of the macula (Bressler et al., 2014, Loftus et al., 2011, Nguyen et al., 2010, Okamoto et al., 2014). Wisconsin Epidemiologic Study of Diabetic Retinopathy has reported that 20% of patients with type 1 diabetes and 25% of those with type 2 diabetes will develop diabetic macular edema (DME) (Hariprasad et al., 2008). If left untreated, the disease may result in blindness and reduced quality of life.

There are several therapeutic modalities for DME, such as focal laser photocoagulation, intravitreal or subtenon’s injection of triamcinolone acetonide, intravitreal bevacizumab, and pars plana vitrectomy (Bressler et al., 2014, Hariprasad et al., 2008, Loftus et al., 2011, Nguyen et al., 2010, Okamoto et al., 2014). The Early Treatment for Diabetic Retinopathy Study (ETDRS) has reported the beneficial effect of laser photocoagulation for patients with clinically significant macular edema (CSME) (Brown et al., 2013, Tranos et al., 2004). Recently, the RISE and RIDE Phase III studies have clearly demonstrated the beneficial effect of intravitreal injection of ranibizumab (Lucentis, Genentech, Inc., South San Francisco, CA), a humanized monoclonal antibody fragment that binds all active forms of VEGF-A, for patients with CSME (Bressler et al., 2014). Previous studies reported that IVR was more effective in improvements of visual acuity, central retinal thickness than the laser treatment in CSME (Bressler et al., 2014, Ip et al., 2014, Mitchell et al., 2011, Mitchell et al., 2013).

The 25-item Visual Function Questionnaire (VFQ-25), created by the National Eye Institute, measures the self-reported vision-targeted health status that is most important to measuring the influence of ophthalmic conditions. The survey measures the influence of visual disability and visual symptoms on health-related quality of life such as emotional well-being and social functioning in patients with severe eye conditions (Aydin Kurna et al., 2014, Freedman et al., 2014, Kaleemunnisha et al., 2014, Lightman et al., 2013, Miskala et al., 2004, Sakai et al., 2013). The purpose of this study was to compare the changes in vision related quality of life (VR-QoL) in patients with DME undergoing IVR injection or focal/grid laser.

Section snippets

Materials and methods

This prospective study enrolled 70 patients with CSME who had been diagnosed at medical retina clinics at Sakarya University Hospital between 1 January 2011 and 1 May 2014. The study was approved by the ethics committee of local university and conducted according to the Declaration of Helsinki. Eligibility criteria included evidence of CSME by means of fundus fluorescein angiography (FFA), at least 6 months of follow-up and no other systemic or ocular disease that might affect vision. Patients

Results

A total of 70 patients with CSME were randomized to undergo IVR injection (n = 35) and focal/grid laser (n = 35). Demographic and clinical characteristics of patients in the two groups are summarized at Table 1. The age, gender distributions and the mean duration of disease were similar in both main groups. Diabetic macular edema was associated frequently with moderate nonproliferative diabetic retinopathy (NPDR) in the two groups. And also, there was no statistical difference in baseline distance

Discussion

In this study, we investigated the effectiveness of treatment choices on the VR-QoL in patients with DME. All patients received the treatment in their better-seeing eye. We thought that if vision improves in the better-seeing eye, the patient's QoL will generally improve. However, the vision improved in the worse-seeing eye and if the fellow eye vision is better, most patients do not generally become aware of improved VR-QoL. Patients treated with IVR and laser had large improvements in

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Conflict of interest: There is no conflict of interest.

None of the authors have any financial support or proprietary interest in the study.

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