Wills Eye Glaucoma Clinical Trials

Glaucoma: Clarifying the Optimal Application of SLT Therapy (COAST)
Principal Investigator (PI): Lauren Hock, MDR
Objective: Randomized clinical trial seeks to compare the efficacy and safety of SLT repeated PRN at standard energy versus annually plus PRN at low energy in treatment naive or minimally treated eyes with ocular hypertension or mild-moderate open-angle glaucoma.
Study population: Adults with high-risk ocular hypertension or mild-moderate primary open angle glaucoma who are treatment naive or have received no more than 6 cumulative months of therapy with topical glaucoma medication within the last 5 years. And have never had IOP lowering surgery or laser.
Coordinator: Meskerem (Mimi) Divers, mdivers@willseye.org

Glaucoma: A Prospective, Multicenter, Non-Randomized Clinical Trial Designed to Evaluate the Safety and Feasibility of the ELIOS System to Reduce Intraocular Pressure in Patients with Primary Open-Angle Glaucoma as a Standalone Procedure (ELIOS)
Principal Investigator (PI): Jonathan Myers, MD
Objective: To evaluate the safety and feasibility of the ELIOS procedure to reduce intraocular pressure in adult subjects with mild to moderate primary open-angle glaucoma (POAG) as a standalone procedure.
Study population: Subjects with POAG, a history of elevated intraocular pressure. Only one (1) eye per subject will be treated under the study protocol (unilateral treatment), but both eyes may be screened. If both eyes qualify for surgery, the eye with the worse best corrected visual acuity (BCVA) will be designated as the study eye. If the visual acuity of both eyes is the same, the nondominant eye will be selected.
Coordinator: Meskerem (Mimi) Divers, mdivers@willseye.org

Glaucoma: A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Subjects with Glaucoma
Principal Investigator (PI): Jonathan Myers, MD
Objective: Study is designed to evaluate the safety and effectiveness of the XEN63 Gel Stent via ab interno and ab externo surgical approaches in subjects with glaucoma when both medical and conventional surgical treatments have failed and when only medical treatments have failed.
Study Population: Adult subjects aged 45 years and older with glaucoma are to be enrolled in the study. Diagnosed with glaucoma uncontrolled by maximal medical therapy (four or more classes of IOP-lowering medications, or fewer in cases where it has been documented that certain medication classes cannot be tolerated or are contraindicated) and failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery, tube shunt). Uncontrolled by medical therapy (to meet OUS requirements) with subjects who only have glaucoma uncontrolled by medical therapy (non-refractory glaucoma), a maximum of 10 subjects who meet only criterion b (and not a) will be enrolled in each cohort.
Coordinator: Jeanne Molineaux, jmolineaux@willseye.org

Glaucoma: Acute Changes in Optic Nerve Head (ONH) and Macular Blood Flow after Caffeine Consumption in Glaucoma Patients and Healthy Subjects: A Quantitative Optical Coherence Tomography Angiography (OCTA) Study
Principal Investigator (PI): Reza Razeghinejad, MD
Objective: The purpose of this study is to learn about the changes in blood flow in the eye after consuming caffeine in glaucoma patients and in healthy subjects. This study aims to learn about the ocular blood flow changes by using OCTA in glaucoma patients at different stages and healthy subjects before and after the ingestion of a 200 mg caffeine tablet, which contains as much caffeine as about 2 cups of coffee.
Study Population: Eligible if subject has glaucoma or you have no eye problems.
Not eligible to participate in this study if you are pregnant or breast-feeding, have anxiety disorder, bipolar disorder, any bleeding disorder, heart disorders, uncontrolled diabetes mellitus, diarrhea, epilepsy, uncontrolled hypertension or osteoporosis.
Coordinator: Jeanne Molineaux, jmolineaux@willseye.org

Project Title: DOMAIN – Optical Coherence Domain Reflectometry & Optical Coherence Tomography Measurements of Intraocular Science
Principal Investigator (PI):
 Joel S. Schuman
Study Aims: This is an observational research study to evaluate eye health using advanced imaging technologies such as Optical Coherence Tomography (OCT). The goal is to identify new biomarkers that can help detect glaucoma earlier and predict how the disease may progress.
You may be eligible to participate if you are 18 or older and either healthy or have an eye condition such as glaucoma, age-related macular degeneration, diabetic retinopathy, or central serous chorioretinopathy. You will not be eligible if you have certain medical or eye conditions that affect vision or eye structure.
Participation involves reviewing your medical history and undergoing OCT imaging of your eyes, which uses safe, low-powered light to take high-quality pictures. Each visit will last less than 60 minutes and may include pupil dilation.
Participants may be enrolled into either a longitudinal or reproducibility group:
Longitudinal group: Follow-up during regular annual eye exams.
Reproducibility group: 5 OCT sessions within one month, each lasting up to 45 minutes.
There is no fixed number of study visits.
Sponsor:
 National Institutes of Health; National Eye Institute
Dates of Enrollment:
 Currently enrolling
Contact Person/Study Coordinator:
 Ronald Zambrano / Ahna Donahue

Project Title:
 visOCT – Evaluation of Longitudinal Changes of the Retinal Layer Structure in Optic Neuropathies Using Visible Light Optical Coherence Tomography
Principal Investigator (PI):
 Joel S. Schuman
Study Aims: This is an observational research study using a new imaging technology called visible light Optical Coherence Tomography (vis-OCT). The purpose of the study is to evaluate how well vis-OCT can detect detailed changes in the retina and to explore whether oxygen levels in the retina (retinal oximetry) can serve as a biomarker for glaucoma.
You may be eligible to participate if you are 18 or older and have been diagnosed with an acute, subacute, or chronic optic neuropathy before the day of your study visit.
Participation involves allowing the study team to review your medical records and taking images of your eyes using the investigational vis-OCT camera. These images are non-invasive and safe. You will continue your regular eye care visits, and the vis-OCT sessions will be added to those visits. There is no set number of study visits.
Sponsor:
 National Institutes of Health; National Eye Institute
Dates of Enrollment:
 Currently enrolling
Contact Person/Study Coordinator:
 Ronald Zambrano / Ahna Donahue

Project Title: VVP - Clustered Home Assessment of Visual Fields in Patients with Glaucoma
Principal Investigator (PI):  Joel S. Schuman
Study Aims: This research study is evaluating the safety and effectiveness of a virtual reality-based device called Vivid Vision Perimetry (VVP). This experimental device is designed to allow people with glaucoma to perform visual field tests from home, with the goal of making testing easier and more precise.
We are inviting individuals who have glaucoma and who have previously completed glaucoma visual field testing. Healthy volunteers with no active eye disease may also be eligible. You may not be eligible to participate if you have certain other eye diseases study or if the study staff determine that you are unable to complete all parts of the study.
Participation in the study will last about 14 months, including 6 clinic visits and 50 at-home VVP tests. Participants will receive $50 for each clinic visit and $100 for every 10 at-home tests completed.
Sponsor:
National Institute of Health; National Eye Institute
Dates of enrollment:
Currently enrolling
Contact person/Study coordinator:
Ronald Zambrano/ Ahna Donahue

Project Title: TUT (Testing the Untestable) – Assessment of Vision Testing Methods
Principal Investigator (PI): Joel S. Schuman
Study Aims: This study is evaluating the safety and effectiveness of experimental vision tests developed by Vivid Vision. These tests use a virtual reality (VR) headset and new user interfaces designed to make vision testing easier and more accessible compared to conventional methods.
We are inviting individuals with glaucoma or other eye conditions, as well as healthy volunteers, to participate. Eligibility will be determined through a review of your medical history, a brief training session, and an eye exam by the study team.
Participation may range from a single 1-hour visit to up to 6 months of involvement, depending on the type of testing you complete. You will receive between $50 and $100 for each clinic visit to help cover expenses like travel and parking. If you complete at-home tests, you will also receive $10 for each test. Payments will be made via debit card at the end of your participation.
You may be invited to join the study in person during a regular clinic visit or contacted by phone or email. If you are eligible and consent to participate, the study device may be provided in clinic, mailed to you, or delivered with training over Zoom.
Sponsor:
National Institute of Health; National Eye Institute
Dates of enrollment:
Currently enrolling
Contact person/Study coordinator:
Ronald Zambrano/ Ahna Donahue

Project Title:
 A Pre-Approval Access Protocol Using Transorbital Alternating Current Stimulation for Optic Neuropathy
Principal Investigator (PI):
 Joel S. Schuman
Study Aims: This is a clinical trial investigating the use of a mild, non-invasive electrical stimulation called transorbital alternating current stimulation (rtACS) for people with visual impairment from optic neuropathy. The goal is to see if rtACS, which works by encouraging the brain to adapt and reorganize (a process called neuroplasticity), can help improve vision.
You may be eligible if you are 18 or older, have been diagnosed with optic neuropathy, and have had visual field defects for at least 6 months (based on two visual field tests).
Participation involves:
A total of 15 visits over a 6-month period
Most of the stimulation is done at home using a device
The study is offered under a compassionate use protocol (not yet FDA-approved)
A one-time cost of $5,000 applies to take part if you meet eligibility criteria
There is no guarantee that vision will improve
You will not be eligible if you have severe vision loss in both eyes, epilepsy, photosensitivity, certain neurological or systemic diseases, electronic implants, or are pregnant or breastfeeding. A full list of exclusion criteria will be reviewed by the study team.
Sponsor:
Donor-based funding
Dates of Enrollment:
Currently waitlisting
Contact Person/Study Coordinator:
 Ronald Zambrano / Ahna Donahue