Clinical Research Directory

Screening for Research Participants

This study will allow National Eye Institute (NEI) doctors the opportunity to examine people with eye disease, whether the diagnosis is known or not, to determine if they are eligible for other NEI research studies. No treatment is offered in this study. People of all ages with various eye conditions, including genetic conditions, eye movement disorders, inflammatory eye diseases, retinal diseases and external eye diseases, may be eligible for this study. Participants undergo various tests and procedures to diagnose or evaluate their eye disease. The procedures may include the following: * Personal and family medical history * Physical examination and blood tests, including genetic testing. * Eye examination with dilation to measure visual acuity and eye pressure and to examine the front and back parts of the eye. * Questionnaire about vision and daily activities. * Conjunctival swab or lacrimal bland biopsy, or both: A sample of cells from the eyes is collected by swabbing the surface of the eye or by surgically removing a small sample of the surface of the eye or tear gland. * Electroretinogram to examine retinal function: The subject sits in the dark with his or her eyes patched for 30 minutes. The patches are removed, the surface of the eyes is numbed, and contact lenses that can sense signals from the retina are placed on the eyes. The subject then watches flashing lights. * Fluorescein angiography to examine the blood vessels in the eye: A dye is injected into a vein in the arm. The dye travels through the veins to the blood vessels in the eyes. A camera takes pictures of the dye as it flows through the blood vessels. * Optical coherence tomography to measure retinal thickness: A machine used to examine the eyes produces cross-sectional pictures of the retina. * Microperimetry to test how sensitive different parts of the retina are to changing levels of light. The subject sits in front of a computer and presses a button when he or she sees a light on the screen. * Oculography to record eye movements: Eye movements are measured by contact lenses or goggles that the subject wears while watching a series of spots on a computer screen.

Advancing Pediatric Retinal Imaging With Auto-aligned OCT

The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.

Study to Evaluate Sepofarsen in Subjects With Leber Congenital Amaurosis (LCA) Type 10 (HYPERION)

The purpose of this double-masked, randomized, placebo-controlled, paired-eye study is to evaluate the efficacy, safety and tolerability of Sepofarsen in subjects with Leber Congenital Amaurosis (LCA) due to the c.2991+1655A\>G (p.Cys998X) mutation in the CEP290.

Rate of Progression in EYS Related Retinal Degeneration

The overall goal of this project funded by the Foundation Fighting Blindness is to characterize the natural history of disease progression in patients with EYS mutations in order to accelerate the development of outcome measures for clinical trials.

Adaptive Optics Retinal Imaging

Background: \- By the time diseases of the retina are detected, serious damage has often already been done. Researchers want to find better ways of viewing the retina. One way called adaptive optics may help detect problems earlier. Objectives: \- To study if adaptive optics can help find better ways to diagnose, treat, and manage retinal diseases. Eligibility: * People over age 12 with an eye disease. * Healthy volunteers over age 12. Design: * Participants will be screened with medical history and eye exams. These may include dilating pupils and taking pictures of the eyes. * Participants will have 1 or more study visits. They will have: * Medical and eye history. * Questions about their medications. * Eye exam including pupil dilation. * Adaptive optics imaging. After dilation, participants sit still while looking into an adaptive optics instrument. They look at specific places and images are taken of their retina. * They may also have: * More images. * Perimetry. Participants look into a lens and press a button when they see a light. * Color vision tests. * Electroretinogram. Participants will get numbing eye drops and special contact lenses. A small metal electrode will be put on their forehead. They will look at flashing lights and try not to blink.

Autologous Serum Tears With Hyaluronate vs Balanced Salt Solution for Moderate-to-Severe Dry Eye

This study aims to find out whether adding sodium hyaluronate, a moisturizing ingredient commonly found in artificial tears, makes autologous serum eye drops more effective for treating moderate-to-severe dry eye disease. Each participant will use one version of the drops in one eye and the standard version in the other eye. The goal is to see if the new combination provides better relief, comfort, and eye surface healing compared to the traditional formulation.

Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER).

The centre of the retina (macula) at the back of the eye contains cells that give us our central vision that we use for reading and recognising faces. These cells can be damaged by a disease called wet age-related macular degeneration (AMD), where new abnormal blood vessels grow through the macula and leak fluid. This can affect vision. In some cases, wet AMD can also cause a bleed under the macula, known as a submacular haemorrhage (SMH), which can lead to marked and persistent loss of vision in the eye. The current standard treatment for wet AMD is to give injections containing 'anti-VEGF' drugs into the eye. Anti-VEGF drugs reduce the leakage of fluid so that the macula can become dry again and sight can improve. Anti-VEGFs are also the current standard of care for SMH, mainly because there is no licensed treatment for the SMH itself (patients with SMH were excluded from most wet AMD studies). The purpose of this study therefore is to compare two treatments: 1. Standard treatment for wet AMD (anti-VEGF injections). 2. Standard treatment above plus surgery. This study will find out if having surgery alongside anti-VEGF injections can improve vision further over the current standard treatment of anti-VEGF injections alone.

Assessment of the Ocular Microbiome in Health and Disease

The objective of this application is to illustrate the core constituents of the ocular surface microbiome, describe factors that promote colonization, and assess the ocular microbiome's role in the health of the anterior segment. We will conduct a prospective, observational cohort study, including a longitudinal analysis of the ocular microbiome in adults.

RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)

The primary objective of this randomized clinical trial is to determine whether repeat trichiasis surgery performed with Bevel-Rotate Advancement Procedure (B-RAP) improves surgical success compared to Bilamellar Tarsal Rotation (BLTR) among a group of 8-10 TT surgeons in Tanzania. The study aims to enroll 1,000 individuals with PTT. The primary outcome is repeat PTT within one year after surgery. Additionally, the study will assess eyelid contour abnormalities and how they change over a two-year period as well as patient reported outcomes. If this project is successful in improving surgical outcomes, it could change the approach to treating PTT globally. Individuals with trichiasis have a significantly reduced quality of life; correcting their trichiasis long-term has the potential to improve their quality of life and their family members' quality of life considerably.

SGLT2 Inhibitors in Geographic Atrophy

AMD is a leading cause of blindness in individuals over 50 years old, with dry AMD being the most common form. Geographic atrophy (GA) is an advanced stage of dry AMD characterized by progressive retinal cell degeneration. The primary objectives of the study are to assess the safety, tolerability, and evidence of activity of SGLT2 inhibitors in subjects with Geographic Atrophy associated with AMD.

Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (SIGHT) 2

To compare eye disease detection rates at a Federally Qualified Health Center between a technology-enhanced protocol and standard optometric clinical examination for three of the leading causes of blindness: glaucoma, diabetic retinopathy, and visually significant cataract.

Switching From Restasis to TRYPTYR

Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Restasis at 28 days post-treatment compared to baseline. Dry eye disease (DED) is a prevalent condition that commonly affects patients of working age in addition to the elderly. DED is a complex condition that results in ocular symptoms such as dryness and burning and signs such as decreased tear production (aqueous deficient DED) or increased tear evaporation (evaporative DED). Unfortunately, there is not a perfect correlation between DED signs and symptoms, which makes diagnosis and timely treatment challenging.

Switching From Xiidra to TRYPTYR

To determine the efficacy of switching participants who are being treated with Xiidra to acoltremon 0.003%. Hypothesis: Switching to acoltremon 0.003% will greatly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline.

Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work

This 1-month, 3-visit study will be conducted at the Southern College of Optometry (Memphis, TN), Kannarr Eye Care, LLC (Pittsburg, KS) and Complete Eye Care of Medina (Minneapolis, MN). Adults ≥18 years of age who have been diagnosed with DED for at least 6 months and who are currently symptomatic (Eye Dryness VAS Score ≥40) will be recruited. Subjects will have an abnormal Schirmer test of \<10 mm/5 min. Subjects will also be required to score ≤70 on the IDEEL Quality of Life (QoL) Work domain to ensure that their DED symptoms are significantly impacting their ability to do work.9 Subjects will be required to have corrected distance visual acuity of 20/32 (0.2 logMAR) or better.

Natural History Study of Patients With EYS-Associated RP

This natural history study of patients with EYS mutations from Russia and former CIS (Commonwealth of Independent States) territories will accelerate the development of outcome measures for clinical trials. Sensitive, reliable outcome measures of retinal degeneration will greatly facilitate development of treatments for retinitis pigmentosa due to EYS mutations. This approach helps to develop experimental treatment protocol, and assessing its effectiveness. The goals and expected impact of this natural history study are to: 1. Describe the natural history of retinal degeneration in patients with biallelic mutations in EYS gene in Russia and former CIS territories. 2. Identify sensitive structural and functional outcome measures to use for future multicenter clinical trials in EYS-related retinal degeneration in Russia and former CIS territories. 3. Identify well-defined subpopulations for future clinical trials of investigative treatments for EYS-related retinal degeneration in Russia and former CIS territories.

Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)

The investigators are conducting a 5-year prospective, 2:1 cluster-randomized controlled trial, funded by the Centers for Disease Control (CDC), which provides vision screenings to underserved New York City residents living in affordable housing buildings in Harlem and Washington Heights.

Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging

The goal of this observational study is to test the use of a novel Widefield Confocal Scanning Laser Ophthalmoscope (WiSLO) Optimized for Pediatric and Neonatal Imaging in pediatric and adult subjects who are undergoing clinical evaluation for eye disease or are healthy adult volunteers. The main questions to answer are: * Whether WiSLO will be more comfortable and satisfactory in experience for the patient and operator than commercial alternatives. * If the quality of WiSLO near infrared images will be comparable to color fundus camera imaging across population of different ages and fundus pigmentation. Participants will have the following research procedures: * Imaging of both eyes with a research noncontact WiSLO * Imaging of both eyes with a commercially available non-contact hand held fundus camera (Volk Pictor Plus) * Likert scales for adults * Pediatric Likert scales for children * CRIES scales for infants.

Investigating Geographic Atrophy Insights (i-GAIN) Natural History Study

An observational study to investigate the natural history and evaluate biomarkers of participants with geographic atrophy secondary to age-related macular degeneration

Safety and Efficacy Study of IVB102 Injection in Subjects With X-linked Retinoschisis

The goal of this clinical trial is to evaluate the safety and efficacy of IVB102 injection in subjects with XLRS.

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for NAION

This trial will study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of non-arteritic ischemic optic neuropathy

Repeated Low-Level Red-Light Therapy for Shortening Axial Length

The purpose of this clinical trial is to confirm the incidence and magnitude of axial length shortening after RLRL therapy in Chinese high myopia children and teenagers.

Non-Interventional Long Term Follow-up Study of Participants Previously Enrolled in the RESTORE Study

This study will be conducted following Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Eligible subjects will be consented to return for scheduled study visits for this study following their completion in study NTXMCO-002 (RESTORE). They will not receive a second treatment with MCO-010 (or a repeated sham injection) in this study

MAD of IVT VP-001 in PRPF31 Mutation-Associated Retinal Dystrophy Subjects (Wallaby)

A Phase 1 Open-Label, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of Intravitreally Administered VP-001 in Participants with Confirmed PRPF31 Mutation-Associated Retinal Dystrophy

Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.