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Clinical Studies

Research and Clinical Studies

In today’s world, patients have numerous options, but often feel uncertain about their medical care in our rapidly changing health care environment. You will find more cutting-edge, innovative medical and surgical technologies at Vold Vison's Research Center than at most major academic medical centers. As global leaders in innovation and clinical research, we can bring you medical technologies found at very few centers in the world. More importantly, we will seek to serve you in such a way that you will know that our motivation for excellence in medical care is driven by our passion for caring for people.

During the past year, our doctors have participated in nearly 20 FDA-approved clinical trials. These studies include the development of innovative surgical devices and techniques, pharmaceutical products, and drug delivery systems. Our specific areas of interest include minimally invasive glaucoma surgery, lens replacement (cataract) surgery, and the development of new medications and methods of drug delivery for the treatment of glaucoma, intraocular inflammation, dry eyes and infection. Many of these products have received approval in Europe and Canada, but are unavailable in the United States at this time. This allows us to provide our patients enhanced ophthalmic care generally at no cost to them. The benefits of these new technologies have been extremely rewarding to our patients.

Benefits to Patients

Participation in ophthalmic research and innovation are an integral part of clinical practice at Vold Vision. We feel strongly that research and innovation enhance patient care and allow us to give back to our patients and society. With nearly 20 years of clinical research experience, we have found that our patients have benefited tremendously from our clinical research programs. We are extremely excited about some of the break-through technologies we will be able to provide you in the months and years ahead. The motivation of our efforts at Vold Vision is to serve you better and ultimately improve ophthalmic care throughout the world.

Vold Vision is selective in what studies they participate in. We select studies after carefully reading the protocol to make sure the study is grounded in solid scientific evidence. We want only the best for our patients and the eye care industry. Vold Vision is always participating in studies. Patient who participate are compensated for their time and efforts and play and significant role in the advancement of vision care.

Clinical Studies Videos

Current Clinical Trial

Vold Vision Patients Participate in InnFocus MicroShunt FDA Clinical Trial

As a national and international leader in glaucoma care, Vold Vision’s FDA Clinical Research Department is deeply engaged in advancing treatment for glaucoma and recently completed the enrollment process for the InnFocus clinical research study. More than 50 Vold Vision patients are participating in the national study, that is determining the safety and effectiveness of a minimally invasive investigational medical device, called the InnFocus Microshunt compared to a traditional glaucoma surgery call trabeculectomy. The InnFocus MicroShunt, is a very small tube designed to drain excess fluid from the patient’s eye. This helps prevent vision loss by reducing the pressure associated with glaucoma. The patients in the study will be monitored over the next two years. The findings from this landmark clinical trial will then be submitted to the FDA for approval. “We are very selective on the studies we chose to participate in,” stated Dr. Michael McFarland, the Director of Research at Vold Vision. We are thankful to be able to bring this study opportunity to our patients.” The InnFocus MicroShunt is about the size of two eyelashes and made of material that has been used in coronary arteries for over 10 years. “The goal of this procedure is to reduce or completely eliminate the use of daily eye drops for glaucoma patients,” Dr. McFarland added. Vold Vision is currently enrolling for other FDA clinical studies. If you would like to find out if you are a research candidate, call Vold Vision at 479-442-8653 and ask for Corinna or Iryna.

MicroShunt

Vold Vision Research Team Members, Corinna and Iryna pictured with the inventor of the InnFocus MicroShunt, Dr. Leonard Pinchuk at a dinner celebrating the final enrollment of the InnFocus study.

Ongoing Clinical Trials

Randomized Study of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System Versus SLT in Primary Open Angle Glaucoma (VISCO360 Study) [Protocol SIGHTVISCO-001]

Sponsor: Sight Sciences, Inc.

The Hydrus Microstent for Refractory Open-Angle Glaucoma: A Prospective, Multicenter Clinical Trial [Protocol CP 16-001]

Sponsor: Ivantis, Inc.

Past Clinical Trials

A Prospective, Randomized, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass System Model G2-W vs. Selective Laser Trabeculoplasty [GC-004]

Sponsor: Glaukos Corp.

A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Suprachoroidal Stent Model G3 in Conjunction with Cataract Surgery [GC-007]

Sponsor: Glaukos Corp.

A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass Stent Model GTS400 using the [email protected] Injector System in Conjunction with Cataract Surgery [GC-008]

Sponsor: Glaukos Corp.

Prospective, Randomized Phase II Study Comparing Two Elution Rates of Glaukos Travaprost Intraocular Implants to Timolol Maleate Ophthalmic Solution, USP, 0.5% [GC-009]

Sponsor: Glaukos Corp.

A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShuntTM Glaucoma Drainage System to Standard Trabeculectomy in Subjects with Primary Open Angle Glaucoma [Protocol INN-005]

Sponsor: InnFocus, Inc.

The Efficacy and Safety of Bimatoprost SR in Patients with Open Angle Glaucoma or Ocular Hypertension [Protocol 192024-092]

Sponsor: Allergan

A Prospective, Past Approval Study to Evaluate the Trulign Toric Posterior Chamber Intraocular Lens [Protocol 858]

Sponsor: Bausch + Lomb

The Safety and Effectiveness of the Hydrus Aqueous Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery, A Prospective, Multicenter, Randomized, Controlled Clinical Trial (Hydrus 4 Study) [Protocol CP 11-001]

Sponsor: Ivantis Inc.

A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys Implant in Subjects with Refractory Glaucoma (FDA Phase II/III Study Protocol #REF-001)

Sponsor: AqueSys, Inc.

A Randomized Phase 2 Study of the Effect of Plug Placement on the Efficacy and Safety of the Latanoprost Puntal Plug Delivery System (LPPDS) in Subjects with Ocular Hypertension (OH) or Open Angle Glaucoma. [Protocol: PPL GLAU 13]

Sponsor: QLT

Clinical Investigation of AcrySof® IQ Monofocal Toric Intraocular Lens Model SN6AT2. [Protocol: C-09-076]

Sponsor: Alcon

A Prospective Randomized Controlled Multi-Center Clinical Study to Evaluate the Safety and Effectiveness of the Light Adjustable Lens in Subjects with Pre-Existing Corneal Astigmatism [Protocol CSP-002-03]

Sponsor: Calhoun Vision, Inc.

A Phase 2 Prospective, Multicenter, Randomized, Double-Masked Clinical Trial to Evaluate the Safety, Efficacy and Dose-Response of the Bimatoprost Ocular Insert (2.2 mg, 13 mg) and Timolol (0.5%) Topical Ophthalmic Solution in Patients with Open-Angle Glaucoma or Ocular Hypertension

Sponsor: ForSight VISION 5, Inc.

Comparative Study of the Safety and Effectiveness of Ologen®Collagen Matrix versus Mitomycin_C in Glaucome Filtering Surgery [Protocol ologen - 2009-02]

Sponsor: Aeon Astron Europe B.V.

Clinical Evaluation of the SOLX GoldShunt for the Reduction of Intraocular Pressure (IOP) in Refractory Glaucoma [Protocol SLX 84]

Sponsor: SOLX, Inc.

Post Approval Study of the AcrySof® IQ Toric High Cylinder Power IOL Models SN6AT6 - SN6AT9 [Protocol C-11-020]

Sponsor: Alcon

Evaluation of Bimatoprost 0.01% and Bimatoprost 0.03% in Patients with Glaucoma and Ocular Hypertension [Protocol 192024-081]

Sponsor: Allergan

A Prospective, Double-Masked, Randomized, Multi-Center, Active Controlled, Parallel Group 12-Month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Subjects with Elevated Intraocular Pressure [Protocol PG324-CS301 Mercury 1]

Sponsor: Aerie Pharmaceuticals, Inc.

A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel Group Phase III Study of the Efficacy and Safety of a Single Sub-Conjunctival Injection of XG-102 for the Reduction of Post-Cataract Surgery Intraocular Inflammation [Protocol SDD-1002-065]

Sponsor: Xigen S.A.