Abstract
Purpose: :
To report visual acuity (VA) and optical coherence tomography (OCT) central subfield thickness (CSF) outcomes 16 weeks following cataract surgery in eyes with central-involved diabetic macular edema (CI-DME).
Methods: :
Prospective, non-comparative, observational study, in which 29 sites enrolled eyes with CI-DME (CSF ≥250 μ on time domain [TD] or ≥310 μ on spectral domain [SD] OCT) scheduled to undergo cataract surgery within 28 days of enrollment. VA and OCT outcomes were assessed 16 weeks after cataract surgery. Treatment for DME before, at day of, or after surgery was at investigator discretion.
Results: :
Sixty among 63 enrolled eyes (95%) completed the 16-week visit. Median age of participants was 64 years, 85% had type 2 diabetes, median duration of diabetes was 19 years, and 13 (22%) had no prior DME treatment. The median pre-operative electronic Early Treatment Diabetic Retinopathy Study VA letter score was 59 (~20/63 Snellen equivalent), while the median CSF was 309 μ (based on TD OCT in 58 eyes). Twenty eyes (33%) did not receive any pre-, peri-, or post-surgical treatment for DME; however, 26 (43%) received post-surgical treatment at a minimum, the most common of which was intravitreal anti-VEGF injection (73%). At 16 weeks, the mean change in VA letter score was +12 (95% confidence interval [CI]: +8 to +16) and 42% (95%CI: 29% to 55%) were 20/40 or better (≥ 73 letters). Thirty-six eyes (60%, 95% CI: 47% to 73%) had VA improvement of at least 2 lines (≥ 10 letters) whereas, 6 eyes (10%, 95% CI: 2% to 18%) lost at least 2 lines (≥ 10 letters) of VA. Mean change in CSF was +18 microns (95% CI: -18 to + 54) relative to the pre-operative visit. Thickness increased ≥1 logOCT unit in 18% (95% CI: 8% to 28%), decreased ≥ 1 logOCT unit in 13%, and resolved in 10%.
Conclusions: :
When pre-, peri- and post-surgical management of macular edema was at investigator discretion, most eyes with pre-operative DME did not exhibit a meaningful increase (at least 1 log unit CSF increase) in macular edema 16 weeks after surgery. With the presence of central-involved DME immediately preceding cataract surgery and standard pre-, peri-, and post-operative management of macular edema, VA appears to improve in a majority of eyes by 16 weeks after surgery. The existence of central-involved DME and visually significant cataract should not automatically preclude cataract surgery.