Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time OCT During Operation

Affiliated Hospital of Nantong University

Status and phase: Enrolling; Phase 3

Conditions: Diabetic Retinopathy

Treatments: Drug: Dexamethasone intravitreal implant; Drug: Ranibizumab Injection [Lucentis]; Procedure: Inner limiting membrane stripping

Study type: Interventional

Funder types: Other

Identifiers

NCT05138029

MSZ20180

Details and patient eligibility

About

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.

Full description

1. Test method:

   • 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.

     • 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Anti-VEGF treatment group

Experimental group

Description:

Visual acuity and center thickness of the macula

Treatment:

Drug: Ranibizumab Injection [Lucentis]

Inner limiting membrane stripping group

Experimental group

Description:

Visual acuity and center thickness of the macula

Treatment:

Procedure: Inner limiting membrane stripping

Glucocorticoid treatment group

Experimental group

Description:

Visual acuity and center thickness of the macula

Treatment:

Drug: Dexamethasone intravitreal implant