Subretinal saline injection added to vitrectomy for diabetic macular edema with hard exudates
Photo by Ian Talmacs / Unsplash
Key Takeaway
Consider subretinal saline injection during vitrectomy as an experimental approach for DME with hard exudates, pending larger comparative trials.
This randomized controlled trial enrolled 56 patients with diabetic macular edema and hard exudates. The intervention group received pars plana vitrectomy with internal limiting membrane peeling plus a subretinal injection of balanced salt solution, while the control group received vitrectomy and peeling alone. The mean follow-up was 7.13 ± 2.02 months.
Within the injection group, best-corrected visual acuity (Snellen) improved from 20/426 ± 20/98 to 20/163 ± 20/59 (P < 0.001). Central macular thickness decreased from 453.32 ± 125.90 µm to 305.14 ± 119.23 µm (P < 0.001). The hard exudates area decreased from 3.00 ± 1.68 mm² to 1.50 ± 1.24 mm² (P < 0.001). The foveal avascular zone area decreased from 0.41 ± 0.11 mm² to 0.32 ± 0.11 mm² (P < 0.001), and mean macular thickness decreased from 411.77 ± 64.52 µm to 322.96 ± 52.62 µm (P < 0.001). All reported P-values are for within-group changes.
Postoperative complications did not differ between groups (P > 0.05). Adverse events, serious adverse events, and discontinuation rates were not reported. Key limitations include the lack of a specified primary outcome, the absence of reported effect sizes or confidence intervals for between-group comparisons, and a short-term follow-up of approximately 7 months. The trial's small size (56 patients) and unreported funding or conflicts of interest are also notable.
For clinical practice, this single, small RCT suggests a potential association between adding a subretinal saline injection to vitrectomy and anatomical improvements in a specific DME subgroup. However, the evidence is insufficient to establish superiority over standard surgery due to the lack of direct between-group statistical comparisons and long-term data. The procedure's safety profile beyond immediate postoperative complications remains unclear.
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View Original Abstract ↓
PURPOSE: To evaluate the efficacy and safety of subretinal balanced salt solution injection for diabetic macular edema patients with hard exudates (HEs) using a 40-gauge curved needle.
METHODS: Patients with diabetic macular edema with HEs were randomized to injection group (subretinal balanced salt solution injection combined with pars plana vitrectomy and internal limiting membrane peeling, n = 28) or control group (pars plana vitrectomy and internal limiting membrane peeling, n = 28). Changes in best-corrected visual acuity, central macular thickness, HEs, foveal avascular zone, and mean macular thickness were compared. Patient demographics, laboratory results, and surgical complications were recorded and compared.
RESULTS: Baseline characteristics were similar ( P > 0.05). In the injection group, compared with the preoperative indicators, the postoperative best-corrected visual acuity (Snellen) improved from 20/426 ± 20/98 to 20/163 ± 20/59, central macular thickness decreased from 453.32 ± 125.90 µ m to 305.14 ± 119.23 µ m, HEs area decreased from 3.00 ± 1.68 mm 2 to 1.50 ± 1.24 mm 2 , foveal avascular zone area decreased from 0.41 ± 0.11 mm 2 to 0.32 ± 0.11 mm 2 , and mean macular thickness decreased from 411.77 ± 64.52 µ m to 322.96 ± 52.62 µ m ( P < 0.001, respectively). Postoperative best-corrected visual acuity, central macular thickness, HEs area, foveal avascular zone, and mean macular thickness in the injection group were different from those in the control group ( P < 0.05). Postoperative complications did not differ ( P > 0.05). The mean follow-up duration was 7.13 ± 2.02 months.
CONCLUSION: Subretinal balanced salt solution injection with a 40-gauge curved needle is safe and effective for diabetic macular edema with HEs, improving macular structure and vision.
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