Chang Ki Yoon1, Min Sagong2, Jae Pil Shin3, Sang Joon Lee4, Joo Eun Lee5, Ji Eun Lee6, Inyoung Chung7, Woo Jin Jeong8, Kang Yeun Pak9, Hyun Woong Kim10,11. 1. Department of Ophthalmology, Seoul National University Hospital, Seoul, Korea. 2. Department of Ophthalmology, Yeungnam University College of Medicine, Daegu, Korea. 3. Department of Ophthalmology, School of Medicine, Kyungpook National University, Daegu, Korea. 4. Department of Ophthalmology, Kosin University college of medicine, Gospel Hospital, Busan, Korea. 5. J Eye Center, Busan, Korea. 6. College of Medicine, Pusan National University, Yangsan, Korea. 7. Institute of Health Sciences, Gyeongsang National University Hospital, Gyeongsang National University, Jinju, Korea. 8. Dong-A University Hospital, Busan, Korea. 9. Inje Univertisy, Haeundae Paik hospital, 875, Haeun-daero, Haeundae-gu, 48108, Busan, Korea. 10. Inje Univertisy, Haeundae Paik hospital, 875, Haeun-daero, Haeundae-gu, 48108, Busan, Korea. maekbak@gmail.com. 11. Inje University Pusan Paik hospital, 875, Haeun-daero, Haeundae-gu, 48108, Busan, Korea. maekbak@gmail.com.
Abstract
BACKGROUND: To investigate the effect of intravitreal dexamethasone implant (DEX implant) on hard exudate (HE) accompanying diabetic macular edema (DME). METHODS: This study was a non-comparative non-randomized 1-year prospective interventional study. Patients with DME and HE were treated using DEX implant two or three times. Color fundus photography and optical coherence tomography (OCT) were performed at every visit. HE area was measured semi-automatically from the fundus photographs. RESULTS: Thirty-five patients completed the study. Eleven patients (31.4%) received two injections, while the remaining received three times. HE area (primary outcome) significantly decreased from 1.404±2.094 mm2 (baseline) to 0.212±0.592 mm2 (last visit), which was 24% of the baseline HE area (P<0.001). HE1500 (HE within 1500 μm from the fovea) area also decreased significantly from 0.382±0.467 mm2 to 0.066±0.126 mm2 (P<0.001). Furthermore, anaverage best corrected visual acuity (BCVA) improvement of 4.4 Early Treatment Diabetic Retinopathy Study (ETDRS) letters was observed (from 49.9±18.3 to 54.3±20.4 letters) (P= 0.008). Central macular thickness (CMT) decreased from 455.8±23.6 μm to 366.8±31.1 μm (P=0.009). Repetitive measurements for entire study duration was analyzed using generalized estimating equations (GEE), where BCVA was related to age, CMT, and HE1500 area in multivariate analyses. CONCLUSION: DEX implant could reduce and suppress HE in DME for one year with two or three injections. And centrally located HE area (HE1500 area) is related to vision. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02399657 , Registered 26 March 2015.
BACKGROUND: To investigate the effect of intravitreal dexamethasone implant (DEX implant) on hard exudate (HE) accompanying diabetic macular edema (DME). METHODS: This study was a non-comparative non-randomized 1-year prospective interventional study. Patients with DME and HE were treated using DEX implant two or three times. Color fundus photography and optical coherence tomography (OCT) were performed at every visit. HE area was measured semi-automatically from the fundus photographs. RESULTS: Thirty-five patients completed the study. Eleven patients (31.4%) received two injections, while the remaining received three times. HE area (primary outcome) significantly decreased from 1.404±2.094 mm2 (baseline) to 0.212±0.592 mm2 (last visit), which was 24% of the baseline HE area (P<0.001). HE1500 (HE within 1500 μm from the fovea) area also decreased significantly from 0.382±0.467 mm2 to 0.066±0.126 mm2 (P<0.001). Furthermore, anaverage best corrected visual acuity (BCVA) improvement of 4.4 Early Treatment Diabetic Retinopathy Study (ETDRS) letters was observed (from 49.9±18.3 to 54.3±20.4 letters) (P= 0.008). Central macular thickness (CMT) decreased from 455.8±23.6 μm to 366.8±31.1 μm (P=0.009). Repetitive measurements for entire study duration was analyzed using generalized estimating equations (GEE), where BCVA was related to age, CMT, and HE1500 area in multivariate analyses. CONCLUSION:DEX implant could reduce and suppress HE in DME for one year with two or three injections. And centrally located HE area (HE1500 area) is related to vision. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02399657 , Registered 26 March 2015.
Authors: Mark C Gillies; Lyndell L Lim; Anna Campain; Godfrey J Quin; Wedad Salem; Ji Li; Stephanie Goodwin; Christine Aroney; Ian L McAllister; Samantha Fraser-Bell Journal: Ophthalmology Date: 2014-08-22 Impact factor: 12.079
Authors: Jeffrey S Heier; Jean-François Korobelnik; David M Brown; Ursula Schmidt-Erfurth; Diana V Do; Edoardo Midena; David S Boyer; Hiroko Terasaki; Peter K Kaiser; Dennis M Marcus; Quan D Nguyen; Glenn J Jaffe; Jason S Slakter; Christian Simader; Yuhwen Soo; Thomas Schmelter; Robert Vitti; Alyson J Berliner; Oliver Zeitz; Carola Metzig; Frank G Holz Journal: Ophthalmology Date: 2016-09-17 Impact factor: 12.079