Co-treatment with dexamethasone implant safe, superior to phaco alone
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Patients with nonproliferative diabetic retinopathy, macular edema and cataract had superior outcomes when treated with the DEX-I intravitreal implant and phacoemulsification compared with patients treated with phacoemulsification alone.
The results were published in Retina.
“[I]n recent years, intravitreal, slow-release implants of corticosteroids have been developed, which can improve both the efficacy and adherence compared to other local therapies,” Claudio Furino, MD, PhD, of the department of medical science, neuroscience and sense organs and eye clinic of the Azienda Ospedaliero-Universitaria Policlinico Consorziale in Bari, Italy, and colleagues wrote. “The good anatomical results observed herein are in agreement with previous studies and suggest that [the dexamethasone implant (DEX-I)] is a promising and well-tolerated treatment to prevent postsurgical increases or ex novo development of [macular edema (ME)] in patients with diabetes.”
To compare functional and anatomical outcomes, Furino and colleagues conducted a retrospective, comparative cohort study. Of the 46 enrolled patients, 23 received phacoemulsification alone (seven women; mean age, 74 years; 11 treated with intravitreal ranibizumab) and 23 received phacoemulsification and DEX-I (dexamethasone intravitreal implant, Ozurdex; seven women; mean age, 71.9 years; nine treated with intravitreal ranibizumab; two with type 1 diabetes). Researchers gathered baseline data on Hba1c levels, best-correct visual acuity (BCVA), central subfield thickness (CST) and IOP. The authors wrote that there were no significant differences between groups. They assessed levels monthly for 3 months. The study’s outcome measures were BCVA, CST and IOP levels.
Researchers found significant differences in BCVA from baseline at month 1 and month 2. Patients who received the dexamethasone intravitreal implant saw mean BCVA increases from the 20/100 baseline to 20/50 that remained consistent at month 1 (P = .0005), month 2 (P = .005) and month 3 (P = .005). Patients treated with phacoemulsification alone had a BCVA baseline of 20/80, 20/63 at month 1 (P = .35 vs. baseline) and remained at 20/80 at month 2 (P = .86 vs. baseline) and month 3 (P = .86 vs. baseline).
Researchers wrote that there was significant variation over the study period in mean CST for both groups. CST was higher at each point among patients treated with phacoemulsification alone compared with patients treated with phacoemulsification and the dexamethasone intravitreal implant (month 1: 361.1 vs. 315.8 microns; month 2: 400.8 vs. 303.7 microns; month 3: 399.2 vs. 298.2 microns).
IOP remained within the normal range for both groups but increased significantly from the 13.4 baseline in the group treated with phacoemulsification and dexamethasone intravitreal implant compared with the changes from the 14.2 baseline among group treated with phacoemulsification alone (month 1: 15.8 vs. 14.4 mm Hg; month 2: 16.5 vs. 14.2 mm Hg; month 3: 15.9 vs. 14.2 mm Hg).
“In diabetic patients with ME and visually significant cataract, combined treatment with phacoemulsification and DEX-I is effective, safe and may be favorable over standard phacoemulsification considering both functional and tomographic parameters,” researchers wrote.
Perspective
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The practicing optometrist must recognize various treatment interventions in response to the rising prevalence of diabetic ocular complications. This retrospective cohort study compared the functional and anatomical outcomes of phacoemulsification in combination with DEX-I to phacoemulsification alone for qualifying cataract surgery patients with nonproliferative diabetic retinopathy and active ME. Patients who received DEX-I in tandem with phacoemulsification had significant improvements in BCVA and reduction in CST compared with their presurgical baselines and compared with patients who received phacoemulsification alone. The stability of these postsurgical results throughout the study supports prior evidence that DEX-I is an effective treatment in reducing diabetic macular edema. The authors did note a statistically significant increase in mean IOP at all follow-up periods for patients who received DEX-I; however, they also reported these IOP results remained within a normal range and did not require intervention. It is the practitioner’s responsibility to account for multifactorial ocular diseases and susceptibility to IOP fluctuations when considering patient candidacy for DEX-I. While the study concludes that DEX-I is effective, well-tolerated and safe, the practitioner must determine potential treatment benefits vs. burdens for each patient.
Study limitations include suboptimal sample sizes and short duration. BCVA, CST and IOP measurements were only recorded at 1, 3 and 3 months post-procedure, affecting the study’s applicability to practitioners who examine postsurgical patients at other timeframes. Therefore, the practitioner must account for each patient’s individual response to treatment and customize clinical follow-up for the observation of recurring diabetic macular edema.
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