Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT04668703
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04668703
Study Brief:
Protocol Section:
NCT04668703