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Clinical Trials and Research

The Department of Ophthalmology and Visual Sciences is actively engaged in clinical trials and research studies involving vision and eye diseases. Our physicians and researchers collaborate with colleagues on a number of investigator-led, industry-sponsored, or government-supported trials that seek to improve vision for our patients and beyond.

Clinical research covers a variety of areas including retinal disease and inherited eye conditions, glaucoma, cornea and external disease, neuro-ophthalmology, pediatric ophthalmology, and more.

If you are interested in volunteering to participate in a clinical study, please visit the UI Hospitals & Clinics Clinical Research Web Site


Research studies are designed to answer important questions about eye disease by testing their safety and effectiveness in patients. Before new medicines, devices or diagnostic tests can be approved for public use, they are all tested in these types of clinical trials.

Below are some of the research studies and projects our researchers are involved in.

AREDS2

AREDS2 is a multi-center randomized trial of approximately 4,200 participants designed to assess the effects of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and omega-3 LCPUFAs (DHA and EPA) for the treatment of AMD and cataract. AREDS2 was designed to evaluate the effects of high supplemental doses of lutein and zeaxanthin and omega-3 LCPUFAs on the development of advanced AMD.

Safety and Efficacy Study in Subjects With Leber Congenital Amaurosis

This study will deliver AAV2-hRPE65v2 vector to twelve subjects, age three or older; subjects will receive the vector via subretinal injection during surgery. The purpose of this research study is to assess the effectiveness and safety of the AAV2-hRPE65v2 gene therapy vector as a possible treatment for Leber Congenital Amaurosis (LCA2).

Idiopathic Intracranial Hypertension Treatment Trial (IIHTT)

Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of elevated intracranial pressure of unknown cause [Corbett, et al., 1982; Wall, et al., 1991]. Its incidence is 22.5 new cases each year per 100,000 overweight women of childbearing age, and is rising [Garrett, et al., 2004] in parallel with the obesity epidemic. It affects about 100,000 Americans. Most patients suffer debilitating headaches. Because of pressure on the optic nerve (papilledema), 86% have some degree of permanent visual loss and 10% develop severe visual loss [Wall, et al., 1991]. Interventions to prevent loss of sight, all with unproven efficacy, include diet, diuretics such as acetazolamide, repeated spinal taps, optic nerve sheath fenestration surgery, and CSF shunting procedures. The purported goal of these therapies is to lower intracranial pressure; however, it is unclear which treatments work and by what mechanism. None of these strategies has been verified by properly designed clinical trials. Thus, there is confusion, uncertainty, and weak scientific rationales to guide treatment decisions. This trial will study subjects who have mild visual loss from IIH to (1) establish convincing, evidence-based treatment strategies for IIH to restore and protect vision, (2) follow subjects up to 4 years to observe the long-term treatment outcomes and (3) determine the cause of IIH. To meet those aims, the trial will be divided into a 12-month intervention phase and a 3-year observational phase. Subjects are not required to complete the observational phase of the study, but will be asked to do so and consented for the observational phase of the study at the conclusion of the intervention phase (12 months).

NORDIC Idiopathic Intracranial Hypertension Treatment Trial

The Neuro-Ophthalmology Research Disease Investigator Consortium (NORDIC) is a cohesive and extensive group of Neuro-Ophthalmologists, other doctors, coordinators, biostatisticians, clinical trial experts and reading centers, who have developed a structured organization to perform prospective clinical research with the support of the National Eye Institute of the NIH, other funding agencies, and industry.

Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface

An estimated 40 million people in the United States wear contact lenses, with approximately 38 million soft lens wearers and 2 million rigid gas permeable lens wearers. The ocular surface has been shown to respond to the introduction of foreign materials with upregulation of proinflammatory mediators, leading to an increase in inflammation. The corneal can show a foreign body immune response to contact lenses. The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across the three lens care regimens in new contact lens wearers.

A Trial of Intensive Multi-Modality Therapy for Extra-Ocular Retinoblastoma

This phase III trial is studying the side effects and how well giving combination chemotherapy together with autologous stem cell transplant and/or radiation therapy works in treating young patients with extraocular retinoblastoma

Collaborative Ocular Melanoma Study

The University of Iowa is a participant in the Collaborative Ocular Melanoma Study (COMS), a multicenter randomized trial sponsored by The National Eye Institute and The National Cancer Institute of the National Institutes of Health.

To find out if there is an active trial taking place involving a specific condition or disease, contact eyeclinicaltrials@uiowa.edu 


Additional information about current and past clinical trials involving vision at The University of Iowa at ClinicalTrials.gov