Purpose
To investigate the outcomes of cataract surgery in patients with active diabetic macular edema (DME) who are receiving active treatment with intravitreal anti–vascular endothelial growth factor (VEGF) injections in the perioperative period.
Design
Retrospective clinical cohort study.
Methods
We reviewed all patients who underwent cataract surgery and were receiving intravitreal anti-VEGF injections from January 1, 2012 through December 31, 2017. Thirty-seven eyes underwent cataract surgery and received ≥1 intravitreal anti-VEGF injection for a diagnosis of DME within 6 months before surgery. Outcome measures included the development of subretinal or intraretinal fluid in the 6 months after surgery, timing of injections, number of injections, best-corrected visual acuity, and central subfield thickness.
Results
There was a significant improvement between pre- and postoperative best-corrected visual acuity when comparing all eyes ( P s < .0001) and no significant difference in central subfield thickness before and after surgery ( P > .05). There were 30 eyes (81.1%) that had fluid on the preoperative optical coherence tomography scan. Seventeen eyes (45.9%) developed new or worsening postoperative DME. Comparing the eyes that did or did not develop worsening DME, there were no differences in postoperative visual acuities ( P > .05). Eyes that did develop new fluid had significant increases in postoperative central subfield thickness at both 1 month (350 vs 320 μm, P = .036) and 6 months (342 vs 305 μm, P = .013).
Conclusion
In a real-world setting, patients with cataracts and actively treated DME may undergo cataract surgery but may see a worsening of DME not immediately affecting the best-corrected visual acuity.
D D iabetic retinopathy is the leading cause of preventable blindness among working adults, affecting more than one-third of patients with diabetes mellitus (DM). Of these patients, diabetic macular edema (DME) remains a leading cause of visual impairment. The visual loss associated with DME is caused by the accumulation and exudation of extracellular fluid within the macula secondary to increased vascular impermeability. The prevalence of DME is 4.2%–7.9% in patients with type 1 DM and 1.4%–12.8% in those with type 2 DM. Patients with DM are also more likely to develop cataracts and tend to develop them at a younger age compared with patients without DM. When patients with DME develop visually significant cataracts, a relevant question is whether cataract surgery will worsen the diabetic eye disease.
Several studies have examined the use of periorbital or intravitreal steroids perioperatively in patients with DME. Intravitreal anti-vascular endothelial growth factor (VEGF) has been shown to be an effective treatment for DME, and newer studies have examined its role in the perioperative management of DME patients undergoing cataract surgery. , These studies mainly focused on DME management at the time of cataract surgery and not on patients who were receiving ongoing treatment for DME. The purpose of this study is to examine the outcomes of patients with DME in a real-world clinical setting who were actively managed with intravitreal anti-VEGF agents before and after cataract surgery.
Methods
This study complied with the Health Insurance Portability and Accountability Act, received prospective Mayo Clinic institutional review board approval, and adhered to the tenets of the Declaration of Helsinki. We performed a retrospective chart review of all patients who underwent cataract extraction and received intravitreal anti-VEGF injections at the Mayo Clinic, Rochester, Minnesota campus, from January 1, 2012 through December 31, 2017. Inclusion criteria were a diagnosis of DME in the operative eye and an intravitreal anti-VEGF injection in the operative eye within 6 months before surgery. Patients receiving ranibizumab 0.5 mg/0.05 mL (Lucentis; Genentech, South San Francisco, CA), bevacizumab 1.25 mg/0.05 mL (Genentech), and aflibercept 2 mg/0.05 mL (Eylea; Regeneron, Tarrytown, NY) were included; there was no differentiation between drugs for the purposes of this study. Patients were typically managed using a modified treat and extend strategy that has been reported previously. Briefly, patients were managed with an initial series of injections (2–4 injections) at a defined interval (typically every 4 weeks) and were re-evaluated with repeat optical coherence tomography (OCT) imaging after the completion of the initial series. Based on the imaging findings and clinical examination, the interval between injections was either increased (improved fluid on OCT), unchanged (stable OCT findings), or decreased if >4 weeks (new fluid on OCT). Patients were excluded if they were receiving anti-VEGF injections for other diseases, such as retinal vein occlusions, exudative age-related macular degeneration, or other causes of choroidal neovascularization. Patients were also excluded if they did not have ≥6 months of follow-up after cataract surgery. Patients were not excluded if they had other concomitant ocular diseases, such as glaucoma or nonexudative age-related macular degeneration.
The OCT findings of the last preoperative OCT and the first 2 OCTs postoperatively were recorded, normally done at 1 month (range 2–8 weeks) and 3 months postoperatively (range 10–16 weeks). Each postoperative OCT was assessed for new or worsening subretinal or intraretinal fluid and the central subfoveal thickness (CST) was recorded. The number of intravitreal injections 6 months before and 6 months after cataract surgery, best-corrected visual acuity, the type of anti-VEGF drug used, and the use of postoperative nonsteroidal anti-inflammatory drug (NSAID) eye drops were also recorded. Visual acuity was recorded using Snellen acuity and converted to logarithm of minimal angle of resolution acuity. Best-corrected visual acuity was recorded at the last preoperative visit before surgery, at 4 to 6 weeks after cataract surgery, and then at 6 months postoperatively. Postoperative refractions were performed by certified ophthalmic assistants.
Data were collected and entered into Microsoft Excel 2010 (Microsoft Corp, Redmond, WA). For statistical analysis, we used JMP software (v 10.0; SAS Institute, Cary, NC). For within-group comparisons, a paired t test was used, and the Wilcoxon rank sum test was performed for comparisons between groups. Group comparisons of the categorical data were performed using the Fisher exact test. P < .05 was considered statistically significant.
Results
There were 40 eyes of 32 patients with DME who were actively being managed with ipsilateral intravitreal anti-VEGF injections and that also underwent cataract during the 5-year study period. Of these, 37 eyes of 30 patients were included in the study. The 3 excluded eyes had insufficient follow-up after cataract surgery. There were 8 eyes (21.6%) that also had concomitant proliferative diabetic retinopathy with previous panretinal photocoagulation. There were 22 eyes of female patients (60.0%) and the mean age of the patients at the time of cataract surgery was 65.8 ± 10.7 years. Twenty-two eyes (60%) were treated with bevacizumab before cataract surgery, 6 (16%) with aflibercept, and 9 (24%) with ranibizumab. The median time from the last injection to cataract surgery was 19 days (4.5–24.5 [25th and 75th quartiles, respectively]). The mean follow-up period after cataract surgery was 365 ± 148 days ( Table 1 ). Thirty eyes (81%) were managed with postoperative topical NSAIDs in addition to topical antibiotics and topical prednisolone eye drops.
| Eyes (n) | 37 |
| Age (yr), mean ± SD | 65.8 ± 10.7 |
| Female, n (%) | 22 (60%) |
| Eyes treated with bevacizumab, n (%) | 22 (60%) |
| Eyes treated with ranibizumab, n (%) | 9 (24%) |
| Eyes treated with aflibercept, n (%) | 6 (16%) |
| Time from last injection to surgery (days), mean ± SD | 19.1 ± 30.4 |
| Length of follow-up (days), mean ± SD | 365 ± 148 |
| Eyes with macular fluid preoperatively, n (%) | 30 (81%) |
| Eyes with new or worsening intraretinal fluid, n (%) | 17 (46%) |
| Eyes with new or worsening subretinal fluid, n (%) | 1 (3%) |
| No. of injections pre-/intraoperatively, mean ± SD | 4.2 ± 1.6 |
| No. of injections postoperatively, mean ± SD | 3.0 ± 2.3 |
The mean preoperative visual acuity for all eyes was 0.73 ± 0.46 (Snellen acuity 20/107). The mean visual acuity 1 month after cataract surgery was 0.32 ± 0.32 (20/42) and at 6 months after surgery was 0.24 ± 0.27 (20/35), both were statistically significant ( P s < .0001, Table 2 ). The mean preoperative CST was 317 ± 83 µm. The 2 subsequent mean CST measurements after cataract surgery were 334 ± 113 µm and 323 ± 93 µm, respectively. Both P values were not statistically significant ( P s = .23 and .83, respectively, Table 2 ). After surgery, 17 eyes (46%) developed increased intraretinal fluid and 1 eye (3%) developed both intraretinal and subretinal fluid ( Table 1 ).
| Mean Preoperative logMAR VA (Snellen) | 1 Month PO logMAR VA (Snellen) | P value | 6-Month PO logMAR VA (Snellen) | P value | |
|---|---|---|---|---|---|
| All eyes (n = 37) | 0.73 ± 0.46 (20/107) | 0.32 ± 0.32 (20/42) | <.0001 a | 0.24 ± 0.27 (20/35) | <.0001 a |
| Mean Preoperative CST (μm) | First PO CST (μm) | Second PO CST (μm) | |||
| All eyes (n = 37) | 317 ± 83 | 334 ± 113 | .23 | 323 ± 93 | .83 |
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