Abeer M Khattab1, Sherein M Hagras2,3, AhmedHosni AbdElhamid4, Magda A Torky1, Eman A Awad1, Ameera G Abdelhameed1. 1. Ophthalmology Department, Mansoura University, Mansoura, Egypt. 2. Ophthalmology Department, Mansoura University, Mansoura, Egypt. shereinhagras@gmail.com. 3. Ophthalmic Center, Faculty of Medicine, Mansoura University, Al-Gomohoria Street, Mansoura, 35516, Egypt. shereinhagras@gmail.com. 4. Ophthalmology Department, Ain-Shams University, Cairo, Egypt.
Abstract
PURPOSE: To assess the impact of micropulsed laser (MPL) on modifying the number of aflibercept injections when used as an adjuvant therapy in diabetic macular edema (DME). METHODS: A prospective randomized interventional clinical study included patients with DME attending Al Hadi Clinic, Kuwait, during the period from May 2017 to December 2018. Patients were allocated in two groups; group A received aflibercept injections alone and group B received combined aflibercept injections followed by MPL within a week. The primary outcome was the number of Aflibercept injections in each group guided by the change in central macular thickness (CMT). All the patients were followed for 18 months. Secondary outcome measures included best corrected visual acuity (BCVA), contrast sensitivity (CS), and any recorded complications. RESULTS:Fifty-four eyes of 51 patients were included (27 in each group). There was no statistically significant difference between the two groups in baseline characteristics except for the age that was statistically higher in group B (p = 0.001). The number of injections were significantly lower in group B (4.1 ± 1.1) than group A (7.3 ± 1.1) (p < 0.005). At 18th month, there was significant reduction in CMT in both groups (p < 0.005) with no statistical difference between the two groups (p = 0.989). Final BCVA in both groups showed statistically significant improvement (p < 0.005) without statistically significant difference between the two groups (p = 0.082). In both groups, the CS showed significant improvement from baseline (p < 0.005). No ocular or systemic adverse effects were observed in either group. CONCLUSION: Supplemental MPL in eyes with DME may decrease the burden of the aflibercept injection frequency while resulting in comparable anatomical and visual outcomes.
RCT Entities:
PURPOSE: To assess the impact of micropulsed laser (MPL) on modifying the number of aflibercept injections when used as an adjuvant therapy in diabetic macular edema (DME). METHODS: A prospective randomized interventional clinical study included patients with DME attending Al Hadi Clinic, Kuwait, during the period from May 2017 to December 2018. Patients were allocated in two groups; group A received aflibercept injections alone and group B received combined aflibercept injections followed by MPL within a week. The primary outcome was the number of Aflibercept injections in each group guided by the change in central macular thickness (CMT). All the patients were followed for 18 months. Secondary outcome measures included best corrected visual acuity (BCVA), contrast sensitivity (CS), and any recorded complications. RESULTS: Fifty-four eyes of 51 patients were included (27 in each group). There was no statistically significant difference between the two groups in baseline characteristics except for the age that was statistically higher in group B (p = 0.001). The number of injections were significantly lower in group B (4.1 ± 1.1) than group A (7.3 ± 1.1) (p < 0.005). At 18th month, there was significant reduction in CMT in both groups (p < 0.005) with no statistical difference between the two groups (p = 0.989). Final BCVA in both groups showed statistically significant improvement (p < 0.005) without statistically significant difference between the two groups (p = 0.082). In both groups, the CS showed significant improvement from baseline (p < 0.005). No ocular or systemic adverse effects were observed in either group. CONCLUSION: Supplemental MPL in eyes with DME may decrease the burden of the aflibercept injection frequency while resulting in comparable anatomical and visual outcomes.