Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time OCT During Operation
NCT ID: NCT05138029
Last Updated: 2023-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2021-11-15
2024-05-31
Brief Summary
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Detailed Description
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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.
* 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Anti-VEGF treatment group
Visual acuity and center thickness of the macula
Ranibizumab Injection [Lucentis]
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.
Inner limiting membrane stripping group
Visual acuity and center thickness of the macula
Inner limiting membrane stripping
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.
Glucocorticoid treatment group
Visual acuity and center thickness of the macula
Dexamethasone intravitreal implant
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.
Interventions
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Ranibizumab Injection [Lucentis]
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.
Inner limiting membrane stripping
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.
Dexamethasone intravitreal implant
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Combined with other retinal vascular diseases such as retinal vein occlusion
* Cardiorenal insufficiency
* Myocardial infarction or stroke occurred within 6 months.
18 Years
80 Years
ALL
No
Sponsors
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Affiliated Hospital of Nantong University
OTHER
Responsible Party
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Principal Investigators
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Rongrong Zhu, master
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Nantong University
Locations
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Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MSZ20180
Identifier Type: -
Identifier Source: org_study_id
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