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104 active trials for Diabetic Retinopathy

Study of the Safety and Efficacy of APX3330 in Diabetic Retinopathy

The objective of this study is to evaluate the safety and efficacy of APX3330 to treat diabetic retinopathy (DR) and diabetic macular edema (DME).

Start: April 2021

Changes of Macular Vasculature After Uncomplicated Phacoemulsification Surgery Using Optical Coherence Tomography Angiography

To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA, a comparative study between healthy and diabetic patients

Start: April 2021

Mitochondrial DNA in Vitreous Fluid and Blood in Patients With Eye Disease or Ocular Trauma.

This study is to characterize mitochondrial DNA (mtDNA) populations in adults with eye injuries and eye diseases. The eye exam is often hindered by the clouding of tissues involved in injury or disease. This protocol examines the use of mtDNA populations as indicators of developing inflammation and resolution of injury. This may be used to provide proactive treatment or define appropriate treatment needs beyond the indications of an ophthalmological exam.

Start: September 2020

Improve Timely Referral Flow and Compliance of Diabetic Retinopathy Patients

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.

Start: March 2021

Augmenting Referral Pathway to Improve Uptake of Retinal Services by Diabetic Patients

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.

Start: February 2021

Automated Screening of Diabetic Retinopathy Using a Smartphone-based Camera

The prevalence of diabetic retinopathy (DR) in the UK is on the rise. Within 20 years of diabetes diagnosis, nearly all people with type 1 and almost two thirds of people with type 2 diabetes (60%) have some degree of DR. NHS guidelines mandate annual DR screening in all patients aged 12 and above to prevent complications of DR. Screening for DR in England involves labour-intensive manual grading of retinal images through the teleophthalmology platform. Automated retinal image analysis systems with the use of artificial intelligence (AI) may offer an alternative to manual grading. The purpose of this study is to evaluate the performance of a portable, hand-held fundus camera with integrated artificial intelligence for diabetic retinopathy screening by comparing it against the current standard i.e diagnosis provided by trained human graders evaluating the standard photographs/ophthalmologists.

Start: June 2021

Macular Perfusion Changes After Anti-VEGF Versus Targeted Retinal Photocoagulation in Proliferative Diabetic Retinopathy

Diabetic retinopathy (DR) is the most common microvascular complication of diabetes mellitus (DM), while proliferative diabetic retinopathy (PDR) is the principal cause of severe visual loss in patients with diabetes. Since 1981, Panretinal photocoagulation (PRP) has been a standard of treatment for PDR. However, PRP can be associated with adverse effects, including visual field constriction, decreased night vision, and worsening of coexisting diabetic macular edema (DME). For this reason, some authors have advocated targeted treatment with PRP. Targeted retinal laser photocoagulation (TRP) is designed to treat areas of retinal capillary non-perfusion and intermediate retinal ischemic zones in PDR that may spare better-perfused tissue from laser-induced tissue scarring. Protocol S by Diabetic Retinopathy Clinical Research Network (DRCR.net) has shown that patients that receive ranibizumab as anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred PRP are non-inferior regarding improving in visual acuity to those eyes receiving standard prompt PRP therapy for the treatment of PDR. Retinal ischemia is an important factor in the progression and prognosis of diabetic retinopathy. Regarding the effect of anti-VEGF drugs on macular perfusion, several studies have shown mixed results with an increase, decrease, or no effect on perfusion in response to anti-VEGF treatment. In many of these studies, however, patients with more ischemic retinas were not included. Fluorescein angiography (FA) was the method used to assess changes in macular perfusion after anti-VEGF injections in most of the clinical trials. Despite its clinical usefulness, however, FA is known to have documented risks. Optical coherence tomography angiography (OCTA) in macular perfusion evaluation in these cases was recommended by some investigators. Several studies have proved the reliability of OCTA in detecting and quantifying macular ischemia in diabetics. The investigators aim to compare changes in the macular perfusion in patients with PDR after treatment with anti-VEGF therapy versus TRP versus Standard PRP using OCTA.

Start: March 2021

Pars Plana Vitrectomy Combined With Phacoemulsification Cataract Surgery in Phakic Diabetes Retinopathy Patients

Pars plana vitrectomy (PPV) is one of the most widely used surgical therapies to proliferative diabetic retinopathy in the world. However, as a predictable consequence of PPV surgery, postoperative cataract is observed in 79%-95% of phakic diabetes retinopathy patients after PPV in 6-24 months and a subsequent cataract surgery is usually required. While, the subsequent cataract surgeries not only bring additional economy and workload burden, but also increase the surgical risks. Since the two-step surgical approach has its defects, the combination of PPV and phacoemulsification is an ideal surgical option. This study is a multi-center prospective study, aimed to evaluate the effect of PPV combined with phacoemulsification cataract surgery in phakic diabetes retinopathy patients, and make a comparation between the combined surgery and the two-step surgery in patients without severe lens opacities.

Start: February 2021

Providing Financial Incentives to Improve Adherence to Referral Eye Care Visits

Glaucoma is a blinding eye disease increasingly common in older adults, particularly in African Americans, and often diagnosed late in the disease course. It is essential to develop novel health care models, utilizing telemedicine, to improve the ability to detect glaucoma at an earlier stage, and to provide a platform to manage this disease in community-based clinics so that further vision loss is prevented. Our goal is to improve the quality and accessibility of glaucoma detection and management among a vulnerable and at-risk segment of our population.

Start: November 2020

Early Laser Treatment for Diabetic Eye Disease in China : A Pilot Randomized Trial

To compare immediate laser pan-retinal photocoagulation (PRP) treatment of severe or very severe non proliferative diabetic retinopathy (NPDR) stage versus deferral of treatment until the appearance of any proliferative diabetic retinopathy (PDR) in rural and urban patients in China. Interview data from some patients and survey data from ophthalmologists in the study hospitals will help determine acceptability of early treatment, and how to overcome barriers to increased use of this option.

Start: October 2016

Assessment of EyeCheckup as an Automated Diabetic Retinopathy Screening Tool

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).

Start: April 2021

Village-Integrated Eye Worker Trial II - Pilot

Start: May 2018

Village-Integrated Eye Worker Trial II

The vast majority of blindness is avoidable. The World Health Organization (WHO) estimates that 80% of cases of visual impairment could be prevented or reversed with early diagnosis and treatment. The leading causes of visual impairment are cataract and refractive error, followed by glaucoma, age-related macular degeneration (AMD), and diabetic retinopathy (DR). Loss of vision from these conditions is not inevitable; however, identifying at-risk cases and linking cases with appropriate care remain significant challenges. To address the global burden of avoidable blindness, eye care systems must determine optimal strategies for identifying people with or at risk for visual impairment beyond opportunistic screening. Outreach programs can prevent blindness both by screening for asymptomatic disease like age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma and case detection of symptomatic disease like cataract and refractive error. Eye care systems have developed numerous community-based approaches to these identification methods, including screening using telemedicine and case detection via cataract camps or community health worker models, but no studies have been conducted on the comparative effectiveness or cost effectiveness of these various approaches. Technology promises to greatly improve access to sophisticated eye care. AMD, DR, and glaucoma can result in irreversible vision loss, and early diagnosis and effective treatment can prevent progression.Thus, community screening programs may prevent progression and improve the vision of a population.However, mass screening for eye disease is currently not recommended. Although self-evident that early detection can prevent blindness for an individual, no randomized controlled trial has been able to demonstrate that screening improves visual acuity at the community level. However, recent technological advances promise to dramatically change the equation by allowing non-medical personnel to use mobile,easy-to-use retinal imaging devices to diagnose screenable eye diseases such as AMD, DR, and glaucoma. Mobile technology could also transform the way clinics communicate with their patients, improving linkage to and retention in care. Optical coherence tomography (OCT) is an ideal test for community-based screening. OCT can be performed through an undilated pupil and is less subject to optical aberrations due to cataract than is fundus photography. OCT machines have pre-installed algorithms to screen for glaucoma, and major anatomical abnormalities can easily be detected even by novice technicians. The infrared image allows detection of referable diabetic retinopathy, and newer OCT angiography machines offer even more discrimination of early diabetic retinopathy. OCT machines are ever more portable, and could be feasibly used in community-based screening programs. The investigators propose a large cluster-randomized trial in Nepal to compare two community-based blindness prevention programs: (1) a state-of-the-art screening program employing OCT and intraocular pressure testing to screen for glaucoma, DR, and AMD followed by enhanced linkage-to-care to the local eye hospital, and (2) a screening program involving only visual acuity assessment. An initial door-to-door census will assess baseline visual acuity in both study arms. The investigators will compare visual acuity between the two arms through a second door-to-door census 4 years later (primary outcome). The investigators maximize their chances of finding an effect by conducting the study in Nepal, where the burden of undiagnosed eye diseases is high. If successful in Nepal, future studies could assess the generalizability of such a program to other settings, such as rural communities in the industrialized world.

Start: April 2019

Validation Study of RETINA-AI Galaxy™, an Automated Diabetic Retinopathy Screening Device

Diabetes affects approximately 35 million Americans, each of whom needs at least one retinal exam per year. However, majority do not get their eye exam due to multiple prohibitive factors such as cost, transportation, difficulty of taking time off from work, and inconvenience, amongst others. The standard of care in diabetes requires at least an annual eye exam to detect onset of diabetic retinopathy and to treat when indicated. This is important as diabetes is the most common cause of visual impairment and blindness in working age adults in the United States. There are too few trained professionals to diagnose diabetic retinopathy, this prompted the development of RETINA-AI Galaxy an automated software as a medical device which screens for diabetic retinopathy in the primary care setting. This observational study is designed to validate the safety and efficacy of the device.

Start: March 2021

Retinal Care Data Repository

The Retinal Care Data Repository's primary objective is to make data available for Retinal Care to develop algorithms that improve the care of people with retinal diseases.

Start: July 2021

Pars Plana Vitrectomy With Internal Limiting Membrane Peeling Versus Intravitreal Ziv-Aflibercept for Treatment-Naïve Diabetic Macular Edema

Treatment-naïve subjects with center-involved diabetic macular edema undergoing pars plana vitrectomy with internal limiting membrane peeling will have similar visual outcomes but better anatomical outcomes compared to subjects undergoing intravitreal bevacizumab monotherapy at one year.

Start: September 2018

Silicone Oil Versus Long-acting Gas Tamponade in Proliferative Diabetic Retinopathy Patients With High-grade Vitreoretinal Adhesion Undergoing Vitrectomy

Subjects receiving 16% C3F8 gas tamponade during vitrectomy will have better visual acuity and similar postoperative complications to subjects who receive silicone oil tamponade during vitrectomy.

Start: September 2018

Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy for Vitreous Hemorrhaging

Subjects undergoing ILM peeling during vitrectomy will have better visual acuity and lower rates of DME to control subjects

Start: September 2018

Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy

Subject/Participant Groups: Study Group: Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment Control Group: Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment

Start: June 2022

Intelligent Evaluation of Diabetic Retinopathy

Brief Summary: The main objective of EviRed project is to develop and validate a system assisting the ophthalmologist by improving prediction of evolution, and decision making during diabetic retinopathy (DR) follow-up. It will replace the current classification of diabetic retinopathy (DR) which provides an insufficient prediction precision. It will use modern available fundus imaging devices and artificial intelligence (AI) to properly integrate the amount of data they provide with other medical data of the patient. A cohort of 5000 diabetic patients will be recruited and followed for an average of 2 years in order to collect data to train and validate the new prediction system.

Start: December 2020