Clinical Studies

CLINICAL RESEARCH

Clinical research at the University of Utah John A. Moran Eye Center is conducted to contribute to the understanding of ocular diseases; to investigate drugs, devices, and procedures for their treatment; and to optimize outcomes for patients. The collaborative culture that exists among clinical investigators at the Moran Eye Center encompasses the institution’s research, education, outreach, and clinical care missions. Clinical research projects are managed through an organizational structure that provides central resources for regulatory oversight, financial management, and study coordination. Our productive clinical research program involves collaborations with pharmaceutical and device industry, federal agencies, and private foundation sponsors.


RECENTLY COMPLETED PROJECTS

Moran Eye Center investigators and patients participated in the following collaborative projects funded by the National Institutes of Health, National Eye Institute:


Cornea Donor StudyMark Mifflin

Principal Investigator: Mark D. Mifflin, MD

Purpose: The purpose of this study was to determine whether graft-failure rate is equivalent between cornea tissue obtained from donors over 65 years of age and tissue obtained from younger donors. The study also assessed the relationships between graft failure rate and donor/recipient characteristics (such as ABO blood type) and graft endothelial cell density.

Results: Five-year graft survival for cornea transplants at moderate risk for failure is similar using corneas from donors ≥ 66.0 years and donors < 66.0 years. Surgeons and patients now have evidence that corneas comparable in quality to those used in this study from donors through age 75 years are suitable for transplantation.

Reference: Cornea Donor Study Investigator Group1, Gal RL, Dontchev M, Beck RW, Mannis MJ, Holland EJ, Kollman C, Dunn SP, Heck EL, Lass JH, Montoya MM, Schultze RL, Stulting RD, Sugar A, Sugar J, Tennant B, Verdier DD. “The effect of donor age on corneal transplantation outcome: results of the corneal donor study.” Ophthalmology. 2008 April; 115(4): 620-626.e6.


Multicenter Uveitis Steroid Treatment (MUST) TrialAlbert Vitale

Principal Investigator: Albert T. Vitale, MD

Purpose: The purpose of this study was to compare standard systemic treatment (oral corticosteroids, possibly combined with immunosuppressive drugs) for severe non-infectious uveitis to a newly FDA-approved ocular drug implant (controlled release fluocinolone implant).

Results: In each treatment group, mean visual acuity improved over 24 months, with neither approach superior to a degree detectable with the study’s power. Therefore, the specific advantages and disadvantages identified should dictate selection between the alternative treatments in consideration of individual patients’ particular circumstances.

Reference: Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group, Kempen JH, Altaweel MM, Holbrook JT, Jabs DA, Louis TA, Sugar EA, Thorne JE.  “Randomized comparison of systemic anti-inflammatory therapy versus fluocinolone acetonide implant for intermediate, posterior, and panuveitis: the multicenter uveitis steroid treatment trial.” Ophthalmology. 2001 Oct;118(10);1916-26.


Age-related Eye Disease Study (AREDS2)Paul Bernstein

Principal Investigator: Paul S. Bernstein, MD, PhD

Purpose: The AREDS2 trial was designed to assess the effects of oral supplementation with high doses of lutein and zeaxanthin and/or omega-3 fatty acids as a treatment for AMD, cataract, and moderate vision loss. All enrolled participants took study supplements and were followed until the last participant had completed five years of follow up.

Results: Neither omega-3 fatty acids nor lutein/zeaxanthin, when added to the original AREDS formula, had any overall effect on the need for cataract surgery. Adding DHA/EPA or lutein/zeaxanthin to the original AREDS formula (containing beta-carotene) had no overall effect on the risk of advanced AMD. However, trial participants who took AREDS containing lutein/zeaxanthin without beta-carotene had a slight reduction in the risk of advanced AMD, compared to those who took AREDS with beta-carotene. Also, for a subgroup of participants with very low levels of lutein/zeaxanthin in their diet, adding these supplements to the AREDS formula helped lower their risk of advanced AMD.

References:

    1. Age-related Eye Disease Study 2 (AREDS2) Research Group, Chew EY, Clemons TE, Sangiovanni JP, Danis RP, Ferris FL 3rd, Elman MJ, Antoszyk An, Ruby AJ, Orth D, Bressler SB, Fish GE, Hubbard GB, Klein ML, Chandra SR, Blodi BA, Domalpally A, Friberg T, Wong WT, Rosenfeld PJ, Agron E, Toth CA, Bernstein PS, Sperduto RD. “Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression: AREDS2 report No.3.” JAMA Ophthalmology. 2014 Feb;132(2):142-9
    2. Age-related Eye Disease Study 2 Research Group. “Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-related eye disease study 2 (AREDS2) randomized clinical trial.” JAMA. 2013 May 15:309(19):2005-15. doi: 10.1001/jama.2013.4997


Idiopathic Intracranial Hypertension Treatment Trial (IIHTT)Kathleen Digre

Principal Investigator: Kathleen B. Digre, MD

Purpose: Idiopathic Intracranial Hypertension (IIH), also called “pseudotumor cerebri,” causes visual disturbances due to increased pressure within the fluid-filled spaces inside and around the brain.  Approximately 100,000 Americans suffer from IIH symptoms; predominantly overweight women of reproductive age.  The trial was conducted to determine if an inexpensive glaucoma drug, acetazolamide, combined with weight loss, would be an effective treatment.

Results: All 161 participants were prescribed a weight-loss plan intended to reduce their daily intake by about 500 to 1,000 calories.  About half the participants were randomly assigned to also receive acetazolamide. The visual symptoms of participants on acetazolamide improved about twice as much as those on placebo.

Reference: Effect of Acetazolamide on Visual Function in Patients with Idiopathic Intracranial Hypertension and Mild Visual Loss: The Idiopathic Intracranial Hypertension Treatment Trial. NORDIC Idiopathic Intracranial Hypertension Study Group Writing Committee, Wall M, McDermott MP, Kieburtz KD, Corbett JJ, Feldon SE, Friedman DI, Katz DM, Keltner JL, Schron EB, Kupersmith MJ. JAMA. 2014. April 23-30:311(16):1641-51. doi: 10.1001/jama.2014.3312.


CURRENT RESEARCH

Cataract

  • Accuracy of the Holladay 2 Formula Using Lenstar Biometry
  • Refractive Index and Pseudophakic Dysphotopsia
  • Impact of AcrySof Glistenings on Visual Quality
  • Quality-of-Life Assessment in an Indigent Population Following Cataract Surgery

Cornea

  • Retrospective Study of Descemet's Stripping Automated Endothelial Keratoplasty Outcomes
  • Biomechanical Changes in the Cornea after Laser Assisted in situ Keratomileusis (LASIK) and Photorefractive Keratectomy (PRK)
  • Topical Proparacaine vs Tetracaine in Photorefractive Keratectomy (PRK)

General

  • Potential for Vision Loss Following Blast Exposure
  • Experience in an Ophthalmology Clinic for Homeless Patients

Glaucoma

  • Communication about Glaucoma and Patient Outcomes

Neuro-Ophthalmology

  • Prospective Assessment of Photophobia in Moran Eye Center Patients
  • Evaluation of Optic Neuropathies with Imaging
  • Retrospective Review of Primary and Secondary Causes of Pseudotumor Cerebri
  • Measurement of Critical Flicker Fusion Frequency
  • Proteomics and Genomics of Giant Cell Arteritis
  • Optic Nerve Drusen: Clinical Characterization and Genetic Mapping
  • Treatment of Giant Cell Arteritis with Antibiotics
  • Benign Essential Blepharospasm in Children
  • Posterior Cortical Atrophy

Pediatric

  • Genetics of Pediatric Retinal Disorders
  • Preeclampsia and Retinopathy of Prematurity
  • Genetic Associations in Preterm Infants at Risk of Retinopathy of Prematurity
  • Spectral Domain OCT Imaging of Eyes: a Practical Diagnostic Tool and Methodology
  • Postnatal Growth and Retinopathy of Prematurity Study (G-ROP)
  • Retrospective Analysis of Neurofibromatosis Type 1-associated Optic Glioma Outcome after Treatment
  • Telemedicine Approaches to Evaluating Acute-phase Retinopathy of Prematurity (eROP)
  • Prevalence of Autism Spectrum Disorders in Patients with Oculocutaneous Albinism
  • Pediatric Cataract Surgery Outcomes Registry
  • Clinical Phenotypes of Inherited Retinal Disease

Retina

  • Sub-retinal Versus Intravitreal TPA for Sub-retinal Hemorrhage
  • Macular Pigment Imaging in Infants using the RetCam
  • Utah Center for the Collaborative Study of the Role of Macular Pigment Carotenoids in the Pathogenesis and Treatment of MacTel
  • Natural History of the Progression of Atrophy Secondary to Stargardt Disease: a Retrospective Longitudinal Study (ProgSTAR)
  • Effects of Maternal Nutrition and Intrauterine Growth Restriction on Infant Carotenoid Status
  • Genetic and Epidemiological Study of Diseases of the Posterior Eye
  • Genetic Analysis of Coats' Disease Patients and Correlation of Phenotypic and Imaging Data
  • Value of Genetic Counseling and Testing for Patients who Would Like to Know More About Their Personal Risk of AMD
  • Efficacy of Pars Plana Vitrectomy and Sub-retinal Tissue Plasminogen Inhibitor for the Treatment of Sub-macular Hemorrhage
  • Birdshot Chorioretinopathy OCT Study
  • Utility of Lyme Antibody Testing in the Uveitis Workup
  • Standardization of Uveitis Nomenclature Working Group

CURRENT CLINICAL TRIALS 

A listing of clinical trials currently being conducted at the Moran Eye Center can be found here:


PUBLICATIONS (2013)
  • Bernstein PS, Sharifzadeh M, Liu A, Ermakov I, Nelson K, Sheng X, Panish C, Carlstrom B, Hoffman RO, Gerllermann W. Blue-light reflectance imaging of macular pigment in infants and children. Invest Ophthalmol Vis Sci. 2013 Jun;54(6):4034-40.  Keyword(s): Imaging; Pediatric; Retina/Retinal Diseases
  • Henriksen BS, Chan G, Hoffman RO, Sharifzadeh M, Ermakov IV, Gellermann W, Bernstein PS. Interrelationships between maternal and carotenoid status and newborn infant mauclar pigment optical density and carotenoid status. Invest Ophthalmol Vis Sci. 2013 Aug;54(8):5568-78.  Keyword(s): Imaging; Pediatric; Retina/Retinal Diseases
  • Meyers KJ, Johnson EJ, Bernstein PS, Iyengar SK, Engelman CD, Karki CK, Liu Z, Igo Jr, RP, Truitt B, Klein ML, Snodderly DM, Blodi BA, Gehrs KM, Sarto GE, Wallace RB, Robinson J, LeBlanc ES, Hageman G, Tinker L, Mares JA. Genetic determinants of macular pigments in women of the carotenoids in age-related eye disease study. Invest Ophthalmol Vis Sci. 2013 Mar;54(3):2333-45. Keyword(s): AMD; Epidemiologyl Retina/Retinal Diseases
  • Shelton JB, Digre KB, Gilman J, Warner JEA, Katz BJ. Characteristics of myelinated retinal nerve fiber layer in ophthalmic imaging: Findings on autofluorescence, fluorescein angiographic, infrared, optical coherence tomographic, and red-free images. JAMA Ophthalmol. 2013 Jan;131(1):107-9.  Keyword(s): Neuro-Ophthalmology
  • Hsu M, Jorgensen AJ, Moshirfar M, Mifflin MD. Management and outcomes of descemet stripping automated endothelial keratoplsty with intraocular lens exchange, aphakia, and anterior chamber intraocular lens. Cornea. 2013 May;32(5):e64-8.  Keyword(s): Cornea
  • Kim G, Singleton R, Mifflin MD, Digre KB, Porzio MT, Smith AG. Assessing the reproducibility of quantitative in vivo confocal microscopy of corneal nerves in different corneal locations. Cornea. 2013 Oct;32(10):1331-8.  Keyword(s): Cornea; Neuro-Ophthalmology
  • Kinard K, Jarstad A, Olson RJ. Correlation of visual quality with satisfaction and function in a normal cohort of pseudophakic patients. J Cataract Refract Surg. 2013 Apr;39(4):590-7.  Keyword(s): Cataract; Other: Dysphotopsia; Other: Phacoemulsification
  • Smith AG, Kim G, Porzio M, Allen B, Koach M, Mifflin M, Digre K, Keung BM, Singlton JR. Corneal confocal microscopy is efficient, well-tolerated, and reproducible. J Peripher Nerv Syst. 2013 Mar;18(1):54-8.  Keyword(s): Cornea; Neuro-Ophthalmology