Ophthalmology

Below are current clinical trials.

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1. A Study to Evaluate Fogging in Scleral Contact Lens

   Rochester, Minn.

   The purpose of this study is to quantify potential decreases in visual acuity experienced by patients who experience mid-day fogging during scleral lens wear, compare severity of subjectively reported fogging with clinical findings, and to explore the relationship between scleral lens fitting parameters and mid-day fogging.

2. A Study Assessing the Effectiveness and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

   Rochester, Minn.

   The purpose of this study is to assess the effectiveness and safety of DE-109 440 µg every 2 months in subjects with active, non-infectious uveitis of the posterior segment of the eye (NIU-PS). There is a 6-month, single-arm, open-label period after completion of the 6-month double- masked, controlled period allows the evaluation of the efficacy and safety of intravitreal injection of DE-109 440 µg every 2 months for longer duration than appropriate for a placebo or sham control.

3. A Study to Evaluate Advanced Ultrasound Techniques for Diagnosis of Giant Cell Arteritis

   Rochester, Minn.

   The purpose of this study is to evaluate shear wave data and vascular lumen size determined by Contrast-Enhanced Ultrasound (CEUS) in patients undergoing temporal artery biopsy, to determine the sensitivity and specificity of Shear Wave Elastography (SWE) and CEUS for the diagnosis of temporal arteritis, and to determine the impact of pre-operative ultrasound guided mapping on operative time required for temporal artery biopsy.

    

4. A Study to Evaluate the Effect of Latanoprostene Bunod Ophthalmic Solution 0.024% on Episcleral Venous Pressure and Outflow Facility in Participants With Ocular Hypertension

   Rochester, Minn.

   The primary purpose of this study is to determine the effect of latanoprostene bunod (LBN) ophthalmic solution 0.024% (a single dose and 7 days of once daily [QD] dosing) on 2 aspects of aqueous humor (AqH) dynamics (episcleral venous pressure [EVP] and outflow facility) in participants with ocular hypertension (OHT).

5. Outcomes of Descemet Membrane Endothelial Keratoplasty

   Rochester, Minn.

   The goal of this study is to determine optical and visual function through 5 years after Descemet membrane endothelial keratoplasty (DMEK). The study will also determine graft health (corneal endothelial cell loss) and survival through 5 years after DMEK, and factors associated with these outcomes, as well as assess the relationship between optical and anatomical corneal rehabilitation after DMEK.

6. A Study to Evaluate a Color Test for Patients with Optic Nerve Diseases

   Rochester, Minn.

   The purpose of this study is to evaluate the clinical utility of a quantitative test to measure how color saturation appears in patients with diseases of the optive nerve.

7. A Study of the Effects of Pneumatic Vitreolysis on Macular Hole

   Rochester, Minn.

   The purpose of this study is to determine the proportion with VMT release and MH closure and to assess factors associated with success.  Eyes with vitreomacular traction (VMT) and full-thickness macular holes (MH) will be enrolled into a non-randomized cohort treated with pneumatic vitreolysis (PVL).

8. A Study to Evaluate the Effectiveness of Critical Flicker Fusion in Distinguishing Different Causes of Altered Vision

   Rochester, Minn.

   The purpose of this study is to evaluate the effectiveness of the critical flicker fusion device in distinguishing different kinds of optic neuropathy and visual perception.

9. A Study of the Effects of Pneumatic Vitreolysis on Vitreomacular Traction

   Rochester, Minn.

   The purpose of this study is to determine if pneumatic vitreolysis (PVL) is effective in releasing VMT.  Eyes with idiopathic symptomatic vitreomacular traction (VMT) without a macular hole will be randomly assigned to 0.3-mL intraocular gas (C3F8) injection or sham injection.

10. Exparel Injection for Postoperative Orbital Pain

    Rochester, Minn.

    After surgery to remove the eye, either by enucleation or evisceration, patients have variable levels of pain for several postoperative days. Some patients have almost no discomfort while others require significant amounts of oral narcotics and report pain of 10 out of 10 on a numerical rating scale. The current operative standard is to infiltrate the eye socket with 0.5% bupivacaine during surgery leading to several hours of postoperative analgesia. In 2011, Pacira Pharmaceuticals released a bupivacaine liposomal injectable suspension (Exparel, 1.3%) which offers sustained release of bupivacaine giving postoperative pain control for up to 72 hours. This medication has been used in numerous surgeries including inguinal hernia repair, hemorrhoidectomy, bunionectomy, breast reconstruction, and orthopedic surgery, and the literature reports improved pain control, decreased use of oral opioids, and increased patient satisfaction. There are no reports of the use of Exparel in the ophthalmic literature. The investigators propose a randomized, controlled trial to compare the postoperative pain control offered by sustained release bupivacaine to that offered by standard plain bupivacaine after enucleation or evisceration.