View clinical trials related to Diabetic Retinopathy.
Filter by:In this study, OCTA is used to study the vascular changes following PRP in patients with PDR; regarding vessels density at 1 month and 6 months follow up period and measure superficial, deep, and outer retina for fovea, para-fovea and whole image.
In 2013, it was estimated that 16% (7.5 million) of all Egyptian adults between the ages of 20 and 79 years have type 2 diabetes and 2.6 million have diabetic retinopathy. A small pilot study looking at 323 patients with previously diagnosed diabetes mellitus (DM) and 183 patients with newly diagnosed DM found that the prevalence of diabetic retinopathy (DR) was 48.3% and 10.4% in each group respectively. By 2035, the Middle Eastern Region and Egypt is projected to have an over 96% increase in the diabetes population. Ultrawide field (UWF) imaging is a novel technology that allows the visualization of approximately 82% of the retina in a single image. Its use in diabetic retinopathy (DR) has been widely explored both as a diagnostic as well as a screening tool. Using this technology, more of the peripheral retina can be readily visualized allowing significantly greater hemorrhages/microaneurysms, intraretinal microvascular abnormalities and non-perfusion to be detected. UWF imaging in patients with DM allowed the identification of a distinct sub-set of eyes with lesions that are predominantly distributed in the peripheral retina. Eyes with significantly greater DR lesions in the extended peripheral fields compared to their respective ETDRS fields are said to have predominantly peripheral lesions or PPL. Eyes with PPL are at greater risk of progressing to more advanced DR and developing proliferative diabetic retinopathy (PDR) after 4 years of follow up. The increased risk of vision threatening complications in eyes with PPL has made the identification of these eyes an essential part of DR evaluation and screening. Furthermore, the presence of lesions in the peripheral retina results in a more severe DR grade in approximately 20% of eyes thereby making this tool more accurate at grading DR severity. A recent DRCR retina network multicenter study established earlier findings confirming the validity of this tool in DR management. I-care Ophthalmology Center will acquire the first UWF device in Egypt, the Optos California (Optos Plc, Dunfermline). Scanning laser ophthalmoscopy UWF imaging has been approved by both the FDA and EMA since 2011. Patients with DM, with or without known DR, will be imaged using the UWF imaging device both for diagnosis and screening purposes at I-care Ophthalmology center after informed consent. These images will be graded for the level of retinopathy and the presence/absence of PPL by certified trained graders. Internal validation and continuous quality control will routinely be conducted. Patients with vision threatening retinopathy (moderate non-proliferative diabetic retinopathy or worse, or the presence of diabetic macular edema) will be instructed to come back for further retinal evaluation and ancillary testing. Patients with mild retinopathy will be instructed to come for yearly follow up imaging. The expected duration for data collection will be 5-years, with interim data analysis on a yearly basis. The design although cross sectional, will have a prospective sub-analysis group in patients who have repeat imaging. Data collection and imaging will be conducted in Egypt and anonymized deidentified data will be shared with the Joslin Diabetes Center, Harvard Ophthalmology Department for joint research purposes. Data will be analyzed for the prevalence of DR and the distribution of DR severity levels in the studied population. In addition, the presence and absence of PPL and its association with DR progression will be studied. Non-modifiable (duration of DM, age of onset, type of DM etc.) and modifiable risk factors (HbA1c, hypertension, hyperlipidemia etc.) for increased risk of DR progression will also be analyzed. Sensitivity analysis will explore the sensitivity/specificity of initial DR grading compared to trained retina specialists.
Observational, comparative, cross-sectional study
This study is open to adults with diabetic macular ischemia who have received laser treatment. The main purpose of this study is to find out whether people with diabetic macular ischemia can tolerate a medicine called BI 765128. In this study, BI 765128 is given to people for the first time. The study has 2 parts. Part A tests 3 doses of BI 765128. Participants get either a low, medium or high dose of BI 765128 as a single injection into the eye. If participants tolerate it well, the highest dose will be used in part B. In part B, participants are put into 2 groups randomly, which means by chance. 1 group gets BI 765128 as injection into the eye. The other group gets sham injections. A sham injection means that it is not a real injection and contains no medicine. Participants cannot tell whether they get the real injection or a sham injection. In this part, participants receive study treatment once every month for 3 months. Participants in part A are in the study for about 4 months and visit the study site about 8 times. Participants in part B are in the study for about 5 months and visit the study site about 7 times. The doctors regularly check participants' health and take note of any unwanted effects.
This is a multicenter, observational study with primary endpoints to determine the sensitivity and specificity of two investigational software devices that detect the presence of more than mild diabetic retinopathy (mtmDR) in healthcare settings.
The objective of the study is to evaluate the differences in the retinal microcirculation measured by OCT-Angiography in patients with type 1 diabetes between the diagnosis of the disease and after 3 months of insulin treatment.
Lipid levels in the blood are proposed to play a role in the progression of diabetic retinopathy. Lipid levels can be controlled with dyslipidemic drugs, such as fenofibrate. Fenofibrate is known to prevent diabetic microvascular complications by decreasing cholesterol and triglyceride levels. This study aims to investigate the effects of oral fenofibrate on central macular thickness (CMT) and macular volume, as well as on specific biomarkers of endothelial dysfunction (eNOS), inflammation (VCAM-1), and angiogenesis (VEGF) in DR individuals with dyslipidemia.
An effective referral system helps to ensure a close relationship between all levels of the health system and ensures clients receive optimum care at the appropriate level and at affordable cost, and hospital facilities are used optimally and cost-effectively. A referral system requires consideration of all its important components that can be then adjusted to the local situation. Being a system, the important components of a referral system are Health system issues (Service providers, Referral protocols, Communication & transportation provide), Referring facility& Referral practicalities (Client & their condition, Protocols of care, Care provider & documents, Referral decision, Outward referral form, Communicate with referral facility, Client information, Referral register), Referral facility& Referral practicalities (Client with referral form, Treat the client with the document, Rehabilitation plan, Back referral form, Feedback to referring facility, Referral register) and Supervision and capacity building (Referral monitoring, Ensure back referral, Feedback and training to facility staff and Feedback to central level) ((USAID), 2012). There are mainly two limitations on referring Diabetic Retinopathy patients. Patient-related reasons: lack of awareness, belief, cost, distance from screening/ treatment centers, discomfort from dilating drops, efforts to attend yet another center, fear of laser treatment, fear of its impact on quality of life and jobs, lack of family support and guilt surrounding the failure to control blood sugar. Provider-related reasons are poor counseling and advisory services about ocular complications for patients with diabetes, inefficient call and recall system, long waiting times for screening or treatment, and complicated referral mechanism. Lumbini eye institute is a comprehensive tertiary eye care center in western Nepal. In spite of 19 peripheral referral centers under it, there is a poor inflow of Diabetic retinopathy patients as against the estimated disease burden in the catchment area. The objective of our study is to improve timely referral flow from referring centers and compliance with referral cases after the intervention. In order to meet our objective, the investigators tend to implement patient counseling at referral centers, a referral tracking system, and a fast-track mechanism for patients at base hospitals.
Reiyukai Eiko Masunaga Eye Hospital (REMEH) is a non-profitable organization. Retina services were resumed from October 2019. Until this retinal service started, it has been mostly cataract-focused. People are unaware of this new retinal service in the hospital. The investigators would like to fill this gap and our objective is to increase the attendance of patients with Diabetes Mellitus, for retinal screening at REMEH by providing health education intervention to selected physicians and establish a referral pathway. Study Design: pre- post-intervention Methods: The investigators are going to conduct intervention by providing health education on diabetes Retinopathy to the health personnel of Scheer Memorial Hospital. It has been referring eye patients to REMEH as there is no eye department there. Data Management: The demographic information of health personnel of Sheer memorial and demographic information and other variables of the patient who are referred from Scheer Hospital will be collected and entered in an excel sheet. The study period of approximately 16 months (March 2020 to Sep 2021): Initial 10 months for proposal writing, preparation, and getting ethical approval. Feb2021 - April 2021 three months for pretest intervention May- July further data collection and last two months Aug- Sep Analysis and writing result. Results: The proposed outcome is to increase the proportional change in the number of patients availing retinal services and to find out a proportional increase in the number of diabetes screenings from the baseline. Also, a positive outcome is a clear indication for health education, and setting communication between general physicians and specialties will set the path for improvement in a timely health care delivery system.
The duration of diabetes is directly related to eye complications. Diabetic retinopathy affects 80 percent of those who have had diabetes for 20 years or more. At least 90% of new cases can be reduced with proper treatment and monitoring of the eyes. The longer a person has diabetes, the more likely it is to develop diabetic retinopathy. Each year in the United States, diabetic retinopathy accounts for 12% of all new cases of blindness. It is also the leading cause of blindness in people between the ages of 20 and 64. The most important complication of diabetes leading to vision loss is diabetic retinopathy. Depending on this, macular edema, bleeding into the retina and vitreous,neovascular glaucoma can cause blindness. Diabetic retinopathy (DR) is a leading cause of vision-loss globally. Of an estimated 285 million people with diabetes mellitus worldwide, approximately one third have signs of DR and of these, a further one third of DR is vision-threatening DR, including diabetic macular edema (DME). Diabetic retinopathy is a retinal disease that can often be stopped with early diagnosis, but if neglected, it can lead to severe vision loss, including permanent blindness. Diabetes has high morbidity and there are millions of people who should be screened for diabetic retinopathy (DR). Annual eye screening is recommended for all diabetic patients since vision loss can be prevented if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is less than that needed to screen a growing diabetic population. Therefore, the automatic DR screening system will be able to screen more diabetic patients and diagnose them early. EyeCheckup is an automated retinal screening device designed automatically analyze color fundus photographs of diabetic patients to identify patients with referable or vision threatening DR. This study is designed to assess the safety and efficacy of EyeCheckup. The study is a single center study to determine the sensitivity and specificity of EyeCheckup to diabetic retinopathy. EyeCheckup is an automated software device that is designed to analyze ocular fundus digital color photographs taken in frontline primary care settings in order to quickly screen for diabetic retinopathy (DR).