A multicentric Clinical study to assess the quality and performance of Adven-I software device in dignosis of diabatic retinopathy from digital fundus images - Adven-I

Advenio tecnosys Private limited0 个研究点目标入组 120 人开始时间: 待定最近更新: 2023年5月29日

试验速览

暂无简介。

•1.Age >= 18
•2.Male/female
•3.Persons diagnosed with diabetes and prior to the current study have not been diagnosed with Diabetic Retinopathy (DR).
•4.Hemoglobin A1c (HbA1c >= 6.5% based on repeated assessments
•5.Fasting Plasma Glucose (FPG) >= 126 mg/dL (7.0 mmol/L) based on repeated assessments Oral Glucose Tolerance Test (OGTT) with two-hour plasma glucose (2-hr PG) >= 200mg/dL (11.1 mmol/L) using the equivalent of an oral 75g anhydrous glucose dose dissolved in water.
•6.Symptoms of hyperglycemia or hyper glycemic crisis with a random plasma glucose (RPG)>= 200 mg/dL (11.1 mmol/L)
•7.Subjects willing to give written informed consent and come for a regular follow up.

•Uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
•History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
•Currently participating in another investigational eye study and actively receiving investigational product for DR or DME.
•Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation).
•Participant is contraindicated for imaging by fundus imaging systems used in the study:
•Participant is hypersensitive to light
•Participant recently underwent photodynamic therapy (PDT)
•Participant is taking medication that causes photosensitivity
•Participant has a history of angle-closure glaucoma or narrow anterior chamber angles

发起方

Advenio tecnosys Private limited