Biomarkers and predictors for functional and anatomic outcomes for small gauge pars plana vitrectomy and peeling of the internal limiting membrane in naïve diabetic macular edema: The VITAL Study

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.

Ranibizumab Pretreatment in Vitrectomy with Internal Limiting Membrane Peeling on Diabetic Macular Edema in Severe Proliferative Diabetic Retinopathy

“…Studies have confirmed the efficacy of vitrectomy with ILM peeling in the treatment of DME [20,21]. However, whether the removal of the ILM can resolve macular edema and improve vision remains controversial.…”

“…The need for combined ILM peeling in patients with DME, however, is currently controversial. A large number of studies have shown that vitrectomy combined with internal membrane peeling is conducive to the recovery of macular edema and improved vision [10]. For simple vitrectomy or vitrectomy with internal limiting membrane peeling, it is impossible to determine the macular state before surgery because of the complexity of the fundus in patients with PDR, such as those with severe vitreous haemorrhage or tractional retinal detachment.…”

Vitrectomy with internal limiting membrane peeling versus nonsurgical treatment for diabetic macular edema with massive hard exudates

“…Therefore, comparing the evolution of hard exudates, macular edema, and visual results between surgical and medical treatments based on OCT remains a clinically relevant and important concern. Several OCT biomarkers such as inner segment-outer segment (IS-OS) layer, external limiting membrane layer, choroidal thickness, submacular fluid, hyper-reflective foci, and disorganization of retinal inner layers have been identified for DME treated with anti-VEGF, dexamethasone implant, or vitrectomy [ 45 – 48 ]. It is difficult to analyze the morphology and thickness of the choroid using spectral-domain OCT (SD-OCT), which was used in the present study, compared with enhance depth imaging SD-OCT or swept-source OCT.…”

“…Studies have demonstrated that vitrectomy has long-term benefits for diffuse DME [12][13][14], even for those without a thickened and taut posterior hyaloid [15][16][17]. In addition, vitrectomy combined with internal limiting membrane (ILM) peeling has shown favorable anatomical and functional outcomes [18][19][20][21][22].…”

The Jidong Eye Cohort Study: objectives, design, and baseline characteristics

“…Optic nerve degeneration is also regarded as a cause of visual impairment [2][3][4][5][6][7][8]. Therefore, it is critical to identify risk factors of visual impairment to prevent occurrence of ocular vascular abnormalities and optic nerve degeneration among middle-aged or older individuals with the use of images and biomarkers [9][10][11].…”