The integrity of retinal ganglion cells is tightly associated with diabetic macular degeneration that leads to damage and death of retinal ganglion cells,affecting vision.The major clinical treatments for diabetic mac...The integrity of retinal ganglion cells is tightly associated with diabetic macular degeneration that leads to damage and death of retinal ganglion cells,affecting vision.The major clinical treatments for diabetic macular edema are anti-vascular endothelial growth factor drugs and laser photocoagulation.However,although the macular thickness can be normalized with each of these two therapies used alone,the vision does not improve in many patients.This might result from the incomplete recovery of retinal ganglion cell injury.Therefore,a prospective,non-randomized,controlled clinical trial was designed to investigate the effect of anti-vascular endothelial growth factor drugs combined with laser photocoagulation on the integrity of retinal ganglion cells in patients with diabetic macular edema and its relationship with vision recovery.In this trial,150 patients with diabetic macular edema will be equally divided into three groups according to therapeutic methods,followed by treatment with anti-vascular endothelial growth factor drugs,laser photocoagulation therapy,and their combination.All patients will be followed up for 12 months.The primary outcome measure is retinal ganglion cell-inner plexiform layer thickness at 12 months after treatment.The secondary outcome measures include retinal ganglion cell-inner plexiform layer thickness before and 1,3,6,and 9 months after treatment,retinal nerve fiber layer thickness,best-corrected visual acuity,macular area thickness,and choroidal thickness before and 1,3,6,9,and 12 months after treatment.Safety measure is the incidence of adverse events at 1,3,6,9,and 12 months after treatment.The study protocol hopes to validate the better efficacy and safety of the combined treatment in patients with diabetic macula compared with the other two monotherapies alone during the 12-month follow-up period.The trial is designed to focus on clarifying the time-effect relationship between imaging measures related to the integrity of retinal ganglion cells and best-corrected visual acuity.The trial protocol was approved by the Medical Ethics Committee of the Affiliated Hospital of Beihua University with approval No.(2023)(26)on April 25,2023,and was registered with the Chinese Clinical Trial Registry(registration number:ChiCTR2300072478,June 14,2023,protocol version:2.0).展开更多
AIM： To assess and compare the diurnal macular choroidal area fluctuation in normal and primary open angle glaucoma （POAG） groups using enhanced depth imaging optical coherence tomography （EDI-OCT）. METHODS： Tw...AIM： To assess and compare the diurnal macular choroidal area fluctuation in normal and primary open angle glaucoma （POAG） groups using enhanced depth imaging optical coherence tomography （EDI-OCT）. METHODS： Twenty-eight normal and 27 POAG eyes were enrolled in this study. EDI-OCT was used to measure the macular choroidal area every 3h from 9：00 a.m. to 21：00 p.m. RESULTS： Significant diurnal fluctuations of macular choroidal area were observed in both normal （P=-0.003） and POAG groups （P〈0.001）. But no significant macular choroidal area difference has been found between the two groups at all the five measurement time-points （512778＋166242 vs 455079：1：207278 pm2, P=-0.195 at 9：00 a.m.; 501526168953 vs 447846.：211147 pm2, P=-0.245 at 12：00 a.m.; 501982＋173158 vs 448024#.206653 pm2, P=-0.239 at 15：00 p.m.; 508912＋174589 vs 457783＋-207081 pm2, P=-0.252 at 18：00 p.m.; 503787＋171241 vs 453230＋_205955 pm2, P=-0.274 at 21：00 p.m.; respectively）. Furthermore, neither the fluctuation manners nor the change in macular choroidal area between the two adjacent measurement time points showed significant difference between normal and POAG groups （all P〉0.05）. In the meantime, significant diurnal intraocular pressure fluctuations were also observed in normal and POAG groups （both P〈0.001）. CONCLUSION： In diurnal time, the macular choroidal area in both normal and POAG groups fluctuated significantly; moreover, neither the value of macular choroidal area, nor the fluctuation of macular choroidal area in POAG group is significantly different from that in normal group.展开更多
基金supported by Science and Technology Research Project of Jilin Provincial Department of Education,No.JJKH20220072KJ(to XL)Science and Technology Development Program of Jilin Province,No.20200201495JC(to YL)。
文摘The integrity of retinal ganglion cells is tightly associated with diabetic macular degeneration that leads to damage and death of retinal ganglion cells,affecting vision.The major clinical treatments for diabetic macular edema are anti-vascular endothelial growth factor drugs and laser photocoagulation.However,although the macular thickness can be normalized with each of these two therapies used alone,the vision does not improve in many patients.This might result from the incomplete recovery of retinal ganglion cell injury.Therefore,a prospective,non-randomized,controlled clinical trial was designed to investigate the effect of anti-vascular endothelial growth factor drugs combined with laser photocoagulation on the integrity of retinal ganglion cells in patients with diabetic macular edema and its relationship with vision recovery.In this trial,150 patients with diabetic macular edema will be equally divided into three groups according to therapeutic methods,followed by treatment with anti-vascular endothelial growth factor drugs,laser photocoagulation therapy,and their combination.All patients will be followed up for 12 months.The primary outcome measure is retinal ganglion cell-inner plexiform layer thickness at 12 months after treatment.The secondary outcome measures include retinal ganglion cell-inner plexiform layer thickness before and 1,3,6,and 9 months after treatment,retinal nerve fiber layer thickness,best-corrected visual acuity,macular area thickness,and choroidal thickness before and 1,3,6,9,and 12 months after treatment.Safety measure is the incidence of adverse events at 1,3,6,9,and 12 months after treatment.The study protocol hopes to validate the better efficacy and safety of the combined treatment in patients with diabetic macula compared with the other two monotherapies alone during the 12-month follow-up period.The trial is designed to focus on clarifying the time-effect relationship between imaging measures related to the integrity of retinal ganglion cells and best-corrected visual acuity.The trial protocol was approved by the Medical Ethics Committee of the Affiliated Hospital of Beihua University with approval No.(2023)(26)on April 25,2023,and was registered with the Chinese Clinical Trial Registry(registration number:ChiCTR2300072478,June 14,2023,protocol version:2.0).
文摘AIM： To assess and compare the diurnal macular choroidal area fluctuation in normal and primary open angle glaucoma （POAG） groups using enhanced depth imaging optical coherence tomography （EDI-OCT）. METHODS： Twenty-eight normal and 27 POAG eyes were enrolled in this study. EDI-OCT was used to measure the macular choroidal area every 3h from 9：00 a.m. to 21：00 p.m. RESULTS： Significant diurnal fluctuations of macular choroidal area were observed in both normal （P=-0.003） and POAG groups （P〈0.001）. But no significant macular choroidal area difference has been found between the two groups at all the five measurement time-points （512778＋166242 vs 455079：1：207278 pm2, P=-0.195 at 9：00 a.m.; 501526168953 vs 447846.：211147 pm2, P=-0.245 at 12：00 a.m.; 501982＋173158 vs 448024#.206653 pm2, P=-0.239 at 15：00 p.m.; 508912＋174589 vs 457783＋-207081 pm2, P=-0.252 at 18：00 p.m.; 503787＋171241 vs 453230＋_205955 pm2, P=-0.274 at 21：00 p.m.; respectively）. Furthermore, neither the fluctuation manners nor the change in macular choroidal area between the two adjacent measurement time points showed significant difference between normal and POAG groups （all P〉0.05）. In the meantime, significant diurnal intraocular pressure fluctuations were also observed in normal and POAG groups （both P〈0.001）. CONCLUSION： In diurnal time, the macular choroidal area in both normal and POAG groups fluctuated significantly; moreover, neither the value of macular choroidal area, nor the fluctuation of macular choroidal area in POAG group is significantly different from that in normal group.
