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

Sponsor
Affiliated Hospital of Nantong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05138029
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
15.5
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Ranibizumab Injection [Lucentis]
  • Procedure: Inner limiting membrane stripping
  • Drug: Dexamethasone intravitreal implant
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time Optical Coherence Tomography During Operation
Actual Study Start Date :
Nov 15, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Anti-VEGF treatment group

Visual acuity and center thickness of the macula

Drug: 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.
Other Names:
  • Lucentis
  • Experimental: Inner limiting membrane stripping group

    Visual acuity and center thickness of the macula

    Procedure: 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.

    Experimental: Glucocorticoid treatment group

    Visual acuity and center thickness of the macula

    Drug: 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 Names:
  • Dexamethasone Implants
  • Outcome Measures

    Primary Outcome Measures

    1. Review the patient's vision before surgery [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 Outcome Measures

    1. Review the patient's vision for one day after surgery [The patient's first day after 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.

    2. Review the patient's vision for 7 days after surgery [1st week after 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.

    3. Review the patient's vision for 1 month after surgery [4th week after 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.

    4. Review the patient's vision for 3 months after surgery [12th week after 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.

    5. Review the patient's vision for 6 months after surgery [24th week after 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Affiliated Hospital of Nantong UniversityNantongJiangsuChina226001

    Sponsors and Collaborators

    • Affiliated Hospital of Nantong University

    Investigators

    • Principal Investigator: Rongrong Zhu, master, Affiliated Hospital of Nantong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Affiliated Hospital of Nantong University
    ClinicalTrials.gov Identifier:
    NCT05138029
    Other Study ID Numbers:
    • MSZ20180
    First Posted:
    Nov 30, 2021
    Last Update Posted:
    Mar 8, 2022
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 8, 2022