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Andrew A Moshfeghi, Howard Shapiro, Anne E. Fung; Impact of cataract surgery during treatment with ranibizumab in patients with diabetic macular edema (DME). Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1747.
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Ophthalmologists may be hesitant to perform cataract surgery in patients with DME because of concerns that edema may worsen. We sought to determine how outcomes after cataract surgery were impacted in patients with DME treated with ranibizumab during the RIDE/RISE phase 3 trials.
In RIDE/RISE, patients were randomized 1:1:1 to 0.3 mg or 0.5 mg ranibizumab or sham injections. Patient records were examined for cataract surgeries using the following terms: cataract extraction, cataract removal, cataract surgery, lens implant and lensectomy. For this analysis, the visit prior to cataract surgery was used as the redefined baseline to examine changes in BCVA after cataract surgery. Months post-cataract surgery were defined as 30 ± 15 days to account for variability in when surgery was performed relative to prespecified monthly study visits. Up to ≈20% of post-surgery BCVA assessments could be missing. Cataract surgeries were identified during the 36-month study period for fellow (non-study) and study eyes of ranibizumab-treated patients and fellow (non-study) eyes of sham-treated patients. Due to crossover to 0.5 mg ranibizumab at month 24, study eyes of sham-treated patients were only assessed for cataract surgery during the first 24 study months. Pooled results from RIDE and RISE are presented.
Cataract surgeries were performed in 21 and 71 study eyes and 34 and 76 fellow eyes, in the sham and pooled 0.3/0.5 mg ranibizumab groups, respectively. Eleven study eyes in the sham arm underwent cataract surgery after month 24. The mean BCVA at the last visit prior to cataract surgery (redefined baseline) was higher in the study eyes of patients in the ranibizumab group compared with study eyes receiving sham treatment (Tables 1, 2). All groups experienced improvement in mean BCVA in the months following cataract surgery (Tables 1, 2).
These results suggest that patients with DME who undergo cataract surgery in the midst of monthly ranibizumab therapy are not subject to detrimental post-surgery outcomes and on average gain 2 lines of vision within 1 month following cataract surgery.
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