View clinical trials related to Diabetic Retinopathy.
Filter by:It has been hypothesized that thermal damage of laser pan-retinal photocoagulation may affect macular pigment as well as inner layer cells in the retina, so it was aimed to investigate possible effect of conventional laser pan-retinal photocoagulation on macular pigment optical density in diabetic retinopathy patients without macular edema and pathology in this study.
The purpose of this study is to determine the clinical application of advanced ophthalmic imaging devices such as optical coherence tomography (OCT), retinal function imager (RFI), slit-lamp biomicroscopy (SLB), PERG in diseased eyes and normal controls. There are two phases in this study. The first phase is an observational phase which studies the eye in various conditions. The second phase is an interventional phase which studies the changes in the eyes after taking an over-the-counter medical food (Ocufolin) for 6 months.
Background Diabetic eye disease is the most frequent complication among the 320,000 Danes with diabetes. The formation of new vessels (PDR) in the inner part of the eye (retina) is a feared complication and a leading cause of blindness, since these vessels are fragile and often cause bleeding within the eye. Peripheral retinal laser treatment (PRP) halves the risk of blindness, but often comes with a high prize. The peripheral part of the retina is responsible for the visual field and the night vision, and PRP limits these abilities (i.e. loss of driving license). The technique of PRP has principally been the same for the past 40 years with standard treatment given for all patients. With this one size fits all approach, a substantial number of patients will either be treated too much or too little. Too little treatment is inefficient, and disease progression may occur. Excessive treatment may cause side effects like loss of visual fields and decreased night vision. Therefore, it is important to test if treatment can be applied on an individual basis to give high efficacy treatment with minimal side effects. IMPETUS 2018 - TREAT is the second of two studies aimed at making an individual design for retinal laser treatment. In IMPETUS 2018 - DETECT the investigators demonstrated that non-invasive examinations of the oxygen level and measurements of the retinal vascular tree provide important information of individual treatment response. For instance, if standard PRP led to three per cent higher retinal oxygen saturation, there was a 4-fold risk of disease progression despite treatment. Hence, such a patient would benefit from more treatment to avoid blindness. With these observations at hand, the investigators want to compare a less invasive treatment (individualized laser treatment) against the standard PRP. Another essential aspect in the treatment of PDR is to be able to give the right diagnosis and to evaluate the efficacy of laser treatment. So far, this has been performed by fluorescein angiography. However, this examination are highly person-dependent and unpleasant to patients, and a more objective approach is needed. Optical coherent tomography angiography (OCT-A) is a quick, noninvasive scanning of the retina which is ideal to visualize moving objects like blood within the retinal vessels. The method has been successfully implemented in a number of retinal diseases, but it has never been validated in PDR. Standard PRP is often performed in 3-4 sessions. However, it may be painful, and patients sometimes choose not to complete all sessions after the initial treatment has been given. There is insufficient knowledge of the patient-barriers to treatment, and it is important to address these in an individualized treatment design. Aim In this 6-month 1:1 randomized, prospective study the investigators want to investigate 1) whether individualized retinal laser treatment compared with standard PRP has the same efficacy but less side effects, 2) whether OCT-A can be used as an objective marker for disease activity, and 3) to obtain a better understanding of patient-reported barriers to standard laser treatment PRP and whether these can be addressed with personalized retinal laser treatment. Setup Fifty eight consecutively recruited patients (1 May 2017 - 30 April 2018) with newly diagnosed PDR referred to the Department of Ophthalmology, OUH, and randomly assigned to standard PRP (n=29) or individualized laser treatment (n=29). Intervention Standard laser treatment is performed in all four quadrants of the retina. Individualized laser treatment is only performed in the part(s) of the retina with proliferation(s). Both treatments are carried out at baseline (BL), and additional treatment is given at month three (M3) and/or (M6), if necessary. Investigations Retinal digital images, fluorescein angiography, OCT-A (BL, M3, M6). Test of visual fields, dark adaptation and quality of life (BL, M6). Semi-structured interview will be performed with five patients who have received PRP in one eye and individualized laser treatment in the other eye. This will address treatment experience, potential barriers to treatment, etc. What to measure: Differences in need for retreatment, night blindness, visual fields, visual acuity, bleeding in the eye, surgery, and quality of life between the groups.
More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic macular edema (DME) collectively known as diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual eye screening is recommended for all diabetic patients since vision loss can be prevented with laser photocoagulation and anti-VEGF treatment if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is orders of magnitude smaller than that needed to screen the large, growing diabetic population. Therefore, to meet this large unmet need for DR screening, a fully-automated computerized DR screening system is necessary. EyeArt is an automated screening device designed automatically analyze color fundus photographs of diabetic patients to identify patients with referable or vision threatening DED. This study is designed to assess the safety and efficacy of EyeArt.
The PROTECT2 pilot study is a single cohort prospective study to gather pilot data and finalize operational details of the main study. The PROTECT2 main study is a prospective randomized controlled multi-center three group clinical trial. The primary endpoint is the percentage of participants in each study group obtaining a qualified eye examination within 12 months of their enrollment in the study.
More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual eye screening is recommended for all diabetic patients since vision loss can be prevented with laser photocoagulation and anti-VEGF injections if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is orders of magnitude smaller than that needed to screen the large, growing diabetic population. Therefore, to meet this large unmet need for DR screening, a fully-automated computerized DR screening system is necessary. This study is designed to assess the performance of EyeArt, an automated DR screening tool.
To validate new screening instruments for eye disease, increase eye care access in underserved communities, and provide a scientifically implemented method to set up programs for eye disease screening.
This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST) in subjects with centre-involved diabetic macular oedema (DME).
The goal of this research is to develop better tools for diagnosing illness of the feet and legs of people who have diabetes. Investigators will use thermal videos of the foot to aid in the refinement of a system designed to detect signs of diabetic peripheral neuropathy (DPN). The team of investigators will also look at diabetic eye disease and how it might relate to diabetic foot disease.
Comparison between retinal measurements, done by the RT (Retinal Thickness) imaging and a commercial OCT (Optical Coherence Tomography)