Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time Optical Coherence Tomography During Operation
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Review the patient's vision before surgery
Study Overview
Brief Summary
Select Proliferative Proliferative diabetic retinopathy(PDR) patients who are planning to undergo vitrectomy for informed notification. After obtaining informed consent, vitrectomy will be performed. After hemorrhage is removed, the macular shape can be obtained through intraoperative optical coherence tomography (iOCT) real-time scanning. If the central Macular Thickness (CMT) of the patient is ≥250μm, random Enter the Anti-vascular endothelial growth factor (anti-VEGF) treatment group, the internal limiting membrane stripping group and the glucocorticoid treatment group for treatment, and compare the patients' visual acuity (1 day, 7 days, 1 month, 3 months, 6 months) and The thickness of the center of the macula, compare and observe its treatment effect.
Detailed Description
- Test method:
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Include suitable cases of diabetic retinopathy and macular edema Inclusion criteria: a. PDR patients with severe vitreous hemorrhage who cannot collect oct images and require vitrectomy b. Type 2 diabetes, aged 18~80 years old c. Good blood sugar control (glycated hemoglobin <8.3%) d. Sign the informed consent form voluntarily, and are willing and able to follow the outpatient visits and research procedures within the time specified in the trial Exclusion criteria: a. Exclude severe infections of conjunctiva, cornea, and sclera b. Combined with other retinal vascular diseases such as retinal vein occlusion c. Cardiorenal insufficiency d. Myocardial infarction or stroke occurred within 6 months ②Intraoperative real-time operation All patients underwent 25Gauge(25G) transplanter three-channel vitrectomy to remove cloudy vitreous or vitreous hemorrhage and posterior vitreous cortex. Through intraoperative oct, the macular area was observed in real time and the central macular thickness was measured. If central macular thickness (CMT) ≥ 250 μm, anti-VEGF, glucocorticoid, or internal limiting membrane peeling was randomly selected to treat macular edema.
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Re-examine the effect of surgery after operation The visual acuity and the thickness of the center of the macula were reviewed at 1 day, 7 days, 1 month, 3 months, and 6 months after the operation to compare the effect of the operation, and observe the cornea, anterior chamber, vitreous cavity, and intraocular pressure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •PDR patients with severe vitreous hemorrhage who cannot collect oct images and need vitrectomy
- •Type 2 diabetes, aged 18~80 years old
- •Good blood sugar control (glycated hemoglobin <8.3%)
- •Sign the informed consent form voluntarily, and are willing and able to follow the outpatient visits and research procedures within the time specified in the trial
Exclusion Criteria
- •Exclude severe infections of conjunctiva, cornea, and sclera
- •Combined with other retinal vascular diseases such as retinal vein occlusion
- •Cardiorenal insufficiency
- •Myocardial infarction or stroke occurred within 6 months.
Arms & Interventions
Anti-VEGF treatment group
Visual acuity and center thickness of the macula
Intervention: Ranibizumab Injection [Lucentis] (Drug)
Inner limiting membrane stripping group
Visual acuity and center thickness of the macula
Intervention: Inner limiting membrane stripping (Procedure)
Glucocorticoid treatment group
Visual acuity and center thickness of the macula
Intervention: Dexamethasone intravitreal implant (Drug)
Outcomes
Primary Outcomes
Review the patient's vision before surgery
Time Frame: The day before the patient's surgery
Optical Coherence Tomography (OCT) is currently the main examination method for measuring retinal thickness and evaluating DME morphology and fine structure. DME OCT examination has a variety of morphological manifestations and accompanying images, and various manifestations reflect different pathological basis.
Secondary Outcomes
- Review the patient's vision for one day after surgery(The patient's first day after surgery)
- Review the patient's vision for 1 month after surgery(4th week after surgery)
- Review the patient's vision for 6 months after surgery(24th week after surgery)
- Review the patient's vision for 7 days after surgery(1st week after surgery)
- Review the patient's vision for 3 months after surgery(12th week after surgery)