Clinical trial NCT05138029: Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time OCT During Operation
Official title: Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time Optical Coherence Tomography During Operation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Diabetic Retinopathy
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Review the patient's vision before surgery
timeFrame: The day before the patient's surgery
Secondary outcomes:
measure: Review the patient's vision for one day after surgery
timeFrame: The patient's first day after surgery
measure: Review the patient's vision for 7 days after surgery
timeFrame: 1st week after surgery
measure: Review the patient's vision for 1 month after surgery
timeFrame: 4th week after surgery
measure: Review the patient's vision for 3 months after surgery
timeFrame: 12th week after surgery
measure: Review the patient's vision for 6 months after surgery
timeFrame: 24th week after surgery
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Rongrong Zhu, master
role: PRINCIPAL_INVESTIGATOR
References: