Status:
UNKNOWN
Prophylactic Effect of Conbercept Intravitreal Injection at the Conclusion of Cataract Surgery for Diabetic Macular Edema
Lead Sponsor:
Eye & ENT Hospital of Fudan University
Conditions:
Diabetic Macular Edema
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Diabetic macular edema (DME) is an important cause of central vision impairment among people with diabetic retinopathy (DR), which can have a significant adverse effect on daily activities and quality...
Eligibility Criteria
Inclusion
- Patients sign informed consent, and are willing and able to comply with all the follow-ups
- Age ≥ 18 years , both genders
- Diagnosis of type 1 or type 2 diabetes mellitus
- Serum HbA1c ≤ 10%
- Patients with a diagnosis of DR (ETDRS 35-53) and cataract
Exclusion
- CI-DME
- Any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy
- History of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases
- Received anti- VEGF treatment (including intravitreal injection or systematic application) within three months prior to enrollment
- History of panretinal laser photocoagulation (PRP) in the study eye 6 months prior to enrollment, or possibly need panretinal photocoagulation of the study eye during the study
- Intraocular conventional surgery within the past three months
- Traumatic cataract or congenital bilateral cataract in the study eye
- Active ocular or periocular infection in either eye
- Iris neovascularization in the study eye
- Uncontrolled glaucoma, or history of glaucoma surgery
- Aphakia in the study eye
- History of vitrectomy in the study eye
- The density of corneal endothelial cells is lower than 2000/mm2
- Patients with uncontrolled hyperglycemia, or Hemoglobin A1C (HbA1c) ≥10.0%, or under hemodialysis, or started insulin usage within the last 4 months, or expected to start insulin use for hyperglycemia control in the next 4 months
- Any surgical contraindications
- Uncontrolled Blood Pressure
- Myocardial infarction, heart failure, stroke, or transient ischemic attack within one month
- Renal Failure
- Pregnant or breast-feeding women
- Participation in another simultaneous medical investigator or trial
- Other situations where the researcher judges that the patient is not suitable for inclusion
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04668703
Start Date
January 1 2021
End Date
January 1 2022
Last Update
December 16 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.