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

Sponsor
Affiliated Hospital of Nantong University
Study ID
NCT05138029
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab Injection [Lucentis] — DRUG
    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 — PROCEDURE
    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 — DRUG
    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 Details

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.

Key Dates

First listed
Nov 30, 2021
Start date
Nov 15, 2021
Status verified
Jul 2023
Primary completion
Dec 31, 2023
Completion
May 31, 2024

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Anti-VEGF treatment group
    Visual acuity and center thickness of the macula
  • Experimental: Inner limiting membrane stripping group
    Visual acuity and center thickness of the macula
  • Experimental: Glucocorticoid treatment group
    Visual acuity and center thickness of the macula

Primary Outcome Measure

Review the patient's vision before surgery [ Time Frame: The day before the patient's surgery ]

Central Contacts

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