Compare the Efficacy of VItrectomy Combined With DExamethasone Implant Versus With Aflibercept in DME Patients Diagnosed by Intraoperative OCT (the VIDEO Study): Study Protocol for a Randomized Controlled Trial
Diabetic Macular Edema, Pars Plana Vitrectomy, Dexamethasone Intravitreal Implant
About this trial
This is an interventional treatment trial for Diabetic Macular Edema
Eligibility Criteria
Inclusion Criteria: ≥18 years of age; Patients and their families fully understand the research and must sign an informed consent form; Patients have a history of diabetes and were diagnosed with PDR by ophthalmic examination; Haemoglobin A1c (HbA1c) levels of <10% within 3 months; No contraindication of vitrectomy; Pseudophakia or this operation is combined with phacoemulsification and lens implantation; Diagnosed with DME by intraoperative optical coherence tomography during vitrectomy Exclusion Criteria: The follow-up period is less than 6 months; Patients need gas or silicon oil tamponade; Patients with rubeosis iridis, neovascular glaucoma and endophthalmitis; Patients with other intraocular surgeries (except cataract surgery with no ruptured posterior lens capsule); Patients with other retinal diseases (i.e., age-related macular degeneration, retinal vein occlusion); Patients received intravitreal Ozurdex three months prior to screening or anti-VEGF injection one month prior to screening; Patients with uncontrolled systemic disease
Sites / Locations
- Tianjin medical university eye hosipital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ozurdex group
Aflibercept group
Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of Ozurdex will be performed at the end of the surgery.
Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of aflibercept will be performed at the end of the surgery.