Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time OCT During Operation
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2021
CompletedStudy Start
First participant enrolled
November 15, 2021
CompletedFirst Posted
Study publicly available on registry
November 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedAugust 1, 2023
July 1, 2023
2 years
September 22, 2021
July 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Review the patient's vision before 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.
The day before the patient's surgery
Secondary Outcomes (5)
Review the patient's vision for one day after surgery
The patient's first day after surgery
Review the patient's vision for 7 days after surgery
1st week after surgery
Review the patient's vision for 1 month after surgery
4th week after surgery
Review the patient's vision for 3 months after surgery
12th week after surgery
Review the patient's vision for 6 months after surgery
24th week after surgery
Study Arms (3)
Anti-VEGF treatment group
EXPERIMENTALVisual acuity and center thickness of the macula
Inner limiting membrane stripping group
EXPERIMENTALVisual acuity and center thickness of the macula
Glucocorticoid treatment group
EXPERIMENTALVisual acuity and center thickness of the macula
Interventions
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.
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.
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
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rongrong Zhu, master
Affiliated Hospital of Nantong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2021
First Posted
November 30, 2021
Study Start
November 15, 2021
Primary Completion
December 1, 2023
Study Completion
May 1, 2024
Last Updated
August 1, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share