Abstract
PurposeWe aimed to investigate biomarkers and predictive factors for visual and anatomical outcome in patients with naïve diabetic macular edema (DME) who underwent small gauge pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling as a first line treatment.DesignMulticenter, retrospective, interventional study.Participants120 eyes from 120 patients with naïve DME treated with PPV and ILM peeling with a follow up of 24 months.MethodsChange in baseline best corrected visual acuity (BCVA) and central subfoveal thickness (CST) 1, 6, 12 and 24 months after surgery. Predictive value of baseline BCVA, CST, optical coherence tomography (OCT) features (presence of subretinal fluid (SRF) and photoreceptor damage), and time between DME diagnosis and surgery. Additional treatment for DME needed. Intra- and post-operative complications (cataract rate formation, increased intraocular pressure).Main outcome measuresThe correlation between baseline characteristics and BCVA response (mean change from baseline; categorized improvement ≥5 or ≥10; Early Treatment Diabetic Retinopathy Study (ETDRS) letters) 12 and 24 months after surgery.ResultsMean BCVA was 0.66 ± 0.14 logMAR, 0.52 ± 0.21 logMAR, and 0.53 ± 0.21 logMAR (p<0.001) at baseline, 12 and 24 months, respectively. Shorter time from DME diagnosis until PPV (OR: 0.98, 95% CI: 0.97–0.99, p<0.001) was a predictor for good functional treatment response (area under the curve 0.828). For every day PPV is postponed, the patient’s chances to gain ≥5 letters at 24 months decrease by 1.8%.Presence of SRF was identified as an anatomical predictor of a better visual outcome, (OR: 6.29, 95% CI: 1.16–34.08, p = 0.033). Safety profile was acceptable.ConclusionsOur results reveal a significant functional and anatomical improvement of DME 24 months after primary PPV, without the need for additional treatment. Early surgical intervention and presence of SRF predict good visual outcome. These biomarkers should be considered when treatment is chosen.
Highlights
Diabetes mellitus is a major healthcare concern in people of working age
Shorter time from Diabetic macular edema (DME) diagnosis until pars plana vitrectomy (PPV) (OR: 0.98, 95% confidence interval (CI): 0.97–0.99, p
Presence of subretinal fluid (SRF) was identified as an anatomical predictor of a better visual outcome, (OR: 6.29, 95% CI: 1.16–34.08, p = 0.033)
Summary
Diabetes mellitus is a major healthcare concern in people of working age. Worldwide, about 93 million are estimated to have diabetic retinopathy (DR).[1]. In addition to the debilitating effect on their vision, DME patients suffer significant impairment of quality of life due to high treatment burden associated with intensive injection regimens. Over a 6-month period, DME patients have an average of 8.8 visits for their ocular condition—which come in addition to about 10 visits with other health care professionals.[8] DME treatment is associated with substantial direct medical costs for the patient, absenteeism for working patients and need for carer’s assistance for injection appointments.[8,9] patients report anxiety and high expectations that lead to negative impact on long term antiVEGF therapy and cause some delay in schedule a new appointment for intravitreal injection. Results from real-life studies are not comparable with the data known from randomized control trials, revealing that the actual number of anti-VEGF injections administered and the proportion of patients achieving significant BCVA gain are lower.[10,11]
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