Clinical Trials/Studies

Clinical Trials/Studies for Fiscal Year 2020

More than 90 clinical research trials and studies are underway at the Moran Eye Center.

CATARACT

Clinical Study of the ARTISAN Aphakia Lens for the Correction of Aphakia in Adults

PI: Craig J. Chaya, MD

Clinical Study of the ARTISAN Aphakia Lens for the Correction of Aphakia in Children

PI: Craig J. Chaya, MD

Expanded Access/Compassionate Use of the Ophtec ARTISAN Aphakia Lens for the Correction of Aphakia

PI: Craig J. Chaya, MD

Relationship Between Geriatric Patient Age and Refractive Outcomes in Cataract Surgery

PI: Jeff Pettey, MD, MBA

Survey of Ophthalmology Residency Programs to Determine Training Frequencies of Extracapsular Cataract Surgery and Small Incision Cataract Surgery

PI: Jeff Pettey, MD, MBA

Pediatric Cataract Surgery Outcomes Registry

PI: Marielle Young, MD

CORNEA

CIRB: Zoster Eye Disease Study (ZEDS)—A multicenter, randomized, double-masked, placebo-controlled clinical trial of suppressive valacyclovir for one year in immunocompetent study participants with an episode of dendriform epithelial keratitis, stroma

PI: Amy Lin, MD

Minimally Invasive Glaucoma Procedures and Corneal Transplants

PI: Amy Lin, MD

Prevention of Exposure Keratopathy in the Medical Intensive Care Unit

PI: Amy Lin, MD

INTACS for Treatment of Keratoconic Patients

PI: Mark D. Mifflin, MD

Survey of Post-Operative Pain in Photorefractive Keratectomy When Using Topical Versus Oral Non-Steroidal Anti-Inflammatory Drugs

PI: Mark D. Mifflin, MD

Outcomes of Topography-Guided Laser-Assisted in Situ Keratomileusis (LASIK) and Photorefractive Keratectomy (PRK) Compared to Wavefront Optimized LASIK and PRK

PI: Mark D. Mifflin, MD

A Phase I/II Randomized, Double-Masked, Placebo-Controlled Study for Determining the Safety of Processed Amniotic Fluid (PAF) Drops after Photorefractive Keratectomy

PI: Mark D. Mifflin, MD

Incidence of Chronic Dry Eye Following Photorefractive Keratectomy and Laser in Situ Keratomileusis

PI: Mark D. Mifflin, MD

Causes of Death and Co-Morbidities among Individuals with Keratoconus

PI: Randall J Olson, MD

GLAUCOMA

Multicenter GATT Retrospective Review

PI: Craig J. Chaya, MD

Effect of Dermatological Pulsed Dye Laser Therapy on Intraocular Pressure in Children with Facial Port Wine Stains

PI: Craig J. Chaya, MD

Glaucoma Surgery in Patients with Uveitis

PI: Craig J. Chaya, MD

Outcomes of Ab-Externo XEN 45 Placement—a New Delivery—in Patients with Glaucoma: EXPAND Study

PI: Craig J. Chaya, MD

Open-Angle Glaucoma after Vitrectomy: A retrospective review

PI: TBA

Virtual Reality Functional Testing to Screen for Early-Stage Glaucoma

PI: Randall J Olson, MD

Pseudoexfoliation and Co-Morbidities

PI: Barbara M. Wirostko, MD

NEURO-OPHTHALMOLOGY

The Use of Color Duplex Sonography in the Evaluation of Giant Cell Arteritis

PI: Alison Crum, MD

Identification of Bacteria in Tissue Specimens from Patients with Giant Cell Arteritis

PI: Bradley J. Katz, MD, PhD

Advanced Imaging Techniques for Better Detection of MLF Lesions Using Multidirection DTI

PI: Meagan Seay, DO

Outcomes after Acute Central Retinal Artery Occlusion

PI: Meagan Seay, DO

Virtual Visual Field Retrospective Analysis

PI: Meagan Seay, DO

Genetic Initiative in Neuro-Ophthalmic Conditions (GINOC)—Idiopathic Intracranial Hypertension (IIH)

PI: Judith E.A. Warner, MD

Documenting Sharp Edge Eye Syndrome (SEES): Clinical and phenotype presentations

PI: Judith E.A. Warner, MD

Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) in Patients Age 50-years or Less

PI: Judith E.A. Warner, MD

OCULOPLASTICS

Patient Satisfaction in Ocular Related Micrographic and Reconstructive Surgery

PI: Douglas Marx, MD

OTHER

Patterns of Blindness in the Navajo Nation: A Retrospective Study

PI: Craig J. Chaya, MD

Visual Impairment among School-Aged Children in Federated States of Micronesia

PI: Craig J. Chaya, MD

Evaluation of a Double-Flipped, Online Ophthalmology Elective

PI: Griffin Jardine, MD

Multivariate Analysis of Variables Affecting Resident Performed Cataract Surgery Complication Rates

PI: Jeff Pettey, MD, MBA

Assessing a Professionalism Mentor in Academic Medical Departments

PI: Jeff Pettey, MD, MBA

Tracking Outcomes in Moran Outreach Programs

PI: Jeff Pettey, MD, MBA

Prevalence of Ophthalmic Disease in a Salt Lake City Homeless Population

PI: Jeff Pettey, MD, MBA

Job Description, Goals and Responsibilities of a Vice Chair of Education within the Department of Ophthalmology

PI: Jeff Pettey, MD, MBA

Sight Outcomes Research (SOURCE) Multicenter Ophthalmology EHR Repository

PI: Brian C. Stagg, MD

Exemption Umbrella: Secondary Analysis of Electronic Medical Record Data to Improve Eyecare

PI: Brian C. Stagg, MD

The Interest and Needs of Eye Care Providers in Clinical Decision Support

PI: Brian C. Stagg, MD

Comparison of the Demographic and Ocular Clinical Profile of Homeless and Non-Homeless Patients in Salt Lake City, Utah

PI: Albert T. Vitale, MD

Reporting Methods, Documentation, and Rates of Intra-Operative Surgery Complications at the John A. Moran Eye Center

PI: Judith E.A. Warner, MD

PEDIATRIC OPHTHALMOLOGY

Collaborative Retrospective Reviews of Rare Pediatric Ophthalmology Diseases

PI: Mary Elizabeth Hartnett, MD

Postnatal Growth and Retinopathy of Prematurity Model Development Study G-ROP-1

PI: Robert O. Hoffman, MD

Growth and Retinopathy of Prematurity Registry (G-ROP Registry)

PI: Robert O. Hoffman, MD

Analysis of Genetic Variant and Treatment Based Variations in Infants at Risk for Retinopathy of Prematurity (ROP)

PI: Leah Owen, MD, PhD

Clinical and Molecular Relationship between Maternal Pre-eclampsia and Retinopathy of Prematurity

PI: Leah Owen, MD, PhD

Clinical Phenotypes of Inherited Retinal Disease

PI: Marielle Young, MD

Building Capacity for Pediatric Eye Care in the Navajo Nation

PI: Marielle Young, MD

PEDIATRIC RETINA

Genetic Associations in Preterm Infants at Risk of Retinopathy of Prematurity

PI: Mary Elizabeth Hartnett, MD

Retrospective Review of Retinopathy of Prematurity and Associated Conditions

PI: Mary Elizabeth Hartnett, MD

ROP1—Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity

PI: Mary Elizabeth Hartnett, MD

ROP2Y—Two-Year Follow-Up after Treatment of 6 Severe Retinopathy of Prematurity with Low-7 Dose Bevacizumab

PI: Mary Elizabeth Hartnett, MD

Vgfte-ROP-1920— Randomized, Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients with Retinopathy of Prematurity

PI: Mary Elizabeth Hartnett, MD

DIGIROP2— Individual Risk Prediction for Sight-Threatening Retinopathy of Prematurity Using Longitudinal Data

PI: Mary Elizabeth Hartnett, MD

RETINA

National Ophthalmic Genotyping Network, Stage 1—Creation of Repository for Inherited Ophthalmic Diseases

PI: Paul S. Bernstein, MD, PhD

Natural History Observation and Registry Study of Macular Telangiectasia Type 2: The MacTel Study

PI: Paul S. Bernstein, MD, PhD

Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD

PI: Paul S. Bernstein, MD, PhD

Utah Center for MacTel Genetics: A Study of Subjects Enrolled in “The Macular Telangiectasia Project” at the University of Utah

PI: Paul S. Bernstein, MD, PhD

Macular Pigment Measurements in Eye and Other Tissues

PI: Paul S. Bernstein, MD, PhD

4D Molecular Therapeutics Protocol Number: 4D-CHM-001-NH0001—A Multicenter Prospective Observational “Natural History” Study in Patients with Choroideremia

PI: Paul S. Bernstein, MD, PhD

Rate of Progression in USH2A Related Retinal Degeneration (RUSH2A) (CIRB)

PI: Paul S. Bernstein, MD, PhD

NTMT-03: A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of Renexus in Macular Telangiectasia Type 2

PI: Paul S. Bernstein, MD, PhD

OPH2005— A Phase 2b Randomized, Double-Masked, Controlled Trial to Establish the Safety and Efficacy of Zimura (Complement C5 Inhibitor) Compared to Sham in Subjects with Autosomal Recessive Stargardt Disease

PI: Paul S. Bernstein, MD, PhD

Detection of Hydroxychloroquine Levels Using Fluorescence Lifetime Imaging

PI: Paul S. Bernstein, MD, PhD

My Retina Tracker Genetic Testing Sub-Study: Feasibility of Enhancing the Data Value of the Patient-Driven Registry My Retina Tracker Through the Provision of Clinical Genetic Testing Services

PI: Paul S. Bernstein, MD, PhD

OAKS-APL2-304— A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy with Sham Injections in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degenerations

PI: Paul S. Bernstein, MD, PhD

XOLARIS— Natural History of the Progression of X-Linked Retinitis Pigmentosa

PI: Paul S. Bernstein, MD, PhD

Lutein and Zeaxanthin in Pregnancy (L-ZIP)— Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects

PI: Paul S. Bernstein, MD, PhD

SeaSTAR: A Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride with Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease

PI: Paul S. Bernstein, MD, PhD

Phase 1 Open-Label, Dose-Escalation Study of the Safety, Tolerability and Preliminary Efficacy of Intravitreal 4D-110 in Patients with Choroideremia

PI: Paul S.Bernstein, MD, PhD

NTMT-03 FLIO Sub-Study

PI: Paul S. Bernstein, MD, PhD

ISEE2008 —A Phase 3 Multicenter, Randomized, Double Masked, Sham-Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients with Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

PI: Paul S. Bernstein, MD, PhD

4D-125-C001— An Open-label, Phase 1/2 Trial of Gene Therapy 4D-125 in Males with X-linked Retinitis Pigmentosa (XLRP) Caused by Mutations in the RPGR Gene

PI: Paul S. Bernstein, MD, PhD

Multimodal Retinal Imaging in Pentosan Polysulfate Associated Maculopathy

PI: Paul S. Bernstein, MD, PhD

The Effect of NMN Supplementation on the FLIO Patterns of Patients with Early Macular Degeneration

PI: Paul S. Bernstein, MD, PhD

Spectral Domain Optical Coherence Tomography Imaging of Eyes: A Practical Diagnostic Tool and Methodology

PI: Mary Elizabeth Hartnett, MD

Growth Factors in Vitreoretinal Diseases

PI: Mary Elizabeth Hartnett, MD

Re-Opening Genetic Analysis of Coats’ Disease Patients (and Family) and Correlation of Patient Phenotypic and Imaging Data

PI: Mary Elizabeth Hartnett, MD

Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy (HIE) in Infants

PI: Mary Elizabeth Hartnett, MD

Retrospective Review of Complications of X-Linked Retinoschisis Especially Causes of Vitreous Hemorrhage

PI: Mary Elizabeth Hartnett, MD

Assessing Efforts to Raise Awareness on OCT: Use of Focus Groups

PI: Mary Elizabeth Hartnett, MD

YOSEMITE—A PHASE III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety Ofro6867461 in Patients with Diabetic Macular Edema

PI: Rachael Jacoby, MD

RHONE-X GR41987—A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients with Diabetic Macular Edema

PI: Rachael Jacoby, MD

Vitreous Biopsy Analysis

PI: Akbar Shakoor, MD

Machine Learning Algorithm for Electroretinography Sorting

PI: Akbar Shakoor, MD

OCT Findings in Patients with Ocular Syphilis

PI: Akbar Shakoor, MD

UVEITIS

Oral Steroids in the Treatment of Bacterial Endophthalmitis

PI: Akbar Shakoor, MD

Macular Edema Ranibizumab vs. Intravitreal Anti-Inflammatory Therapy (MERIT) Trial

PI: Albert T. Vitale, MD

Adalimumab vs. Conventional Immunosuppression for Uveitis (ADVISE) Trial

PI: Albert T. Vitale, MD

CIRB: Adalimumab in Juvenile Idiopathic Arthritis-Associated Uveitis Stopping Trial (ADJUST)

PI: Albert T. Vitale, MD

Phacoemulsification Combined with Pars Plana Vitrectomy in Intermediate Uveitis

PI: Albert T. Vitale, MD