Participation in ophthalmic research and innovation is an integral part of clinical practice at Ophthalmology Associates. Brian Flowers, M.D. has led an FDA clinical research facility focused on Glaucoma for many years. You will find more cutting edge, innovative medical and surgical treatments for glaucoma available here than most major medical academic centers.
We feel strongly that research and innovation enhance patient care and allow us to give back to our patients and society. Because of our excellent glaucoma care, we are sought after to participate in most new projects. However, we are very selective regarding which studies we participate in.
We carefully review the evidence that supports the innovation in question. Often, the surgery or medication is already approved in Europe and/or Canada, yet unavailable in the US. This often provides the ability to evaluate years of experience with a procedure prior to offering it to our patients.
The types of studies in which patients may choose to participate include new medications, new methods of administering medication to avoid the need for eyedrops, and minimally invasive glaucoma surgeries. We are proud to have helped usher in groundbreaking procedures such as canaloplasty, CyPass, and iStents with many others soon to come.
Patients are evaluated for our research studies while at their regular office visit. Our doctors will let a patient know if they qualify for a particular study. Patients are typically eager as the benefits of being a study candidate are many, which include receiving new innovative treatment and reduced cost of care.
Most patients receive a stipend for participating in studies, and often the cost of office visits are covered by the study sponsor. If you are interested in participating, please feel free to call our office and ask to speak with our research coordinator.
Glaukos iStent Inject
Two iStent inject stents are implanted in the eye during cataract surgery within the natural drainage system and may help reduce or eliminate the need for eye drops in some patients.
The stents are designed to reduce intraocular pressure and prevent further vision loss due to glaucoma.
The clinical trials for the iStent Inject and iStent Supra in conjunction with cataract surgery have been completed and is now being evaluated by the FDA for approval.
***There is an ongoing and enrolling trial to evaluate the Glaukos iStent Inject as a stand-alone procedure.
Glaukos iStent Supra
The iStent Supra procedure consists of placing one stent inside your eye, during cataract surgery using the same opening used to take out your cataract.
The iStent Supra stent is placed within a drainage pathway of the eye and is implanted with the goal of lowering pressure. This is done by creating a channel into one of the existing drainage systems that allow fluid to flow out.
The clinical trials for the iStent Inject and iStent Supra in conjunction with cataract surgery have been completed and are now being evaluated by the FDA for approval.
The Hydrus Aqueous Implant, roughly the size of an eyelash is being tested to see if it can relieve the high intraocular pressure (IOP) this is common in patients with primary open-angle glaucoma (POAG). The tiny Hydrus scaffold is designed to be inserted into the primary fluid canal (called Schlemm’s canal) of the eye and open the channel to flow more freely, thus reducing high IOP. http://www.ivantisinc.com/.
The clinical trial for the Hydrus Microstent in conjunction with cataract surgery has been completed and is now being evaluated by the FDA approval and is expected to be approved in late fall 2018.
***There is an ongoing and enrolling trial to evaluate the Hydrus Microstent as a stand-alone procedure.
Transcend Cypass Micro-stent
Transcend Medical has developed micro-stent technology that is designed to be implanted at the time of cataract surgery in patients with primary open-angle glaucoma. The CyPass Micro-Stent is a small device that is implanted just below the surface of the eye.
Acquired February 2016 by Alcon from Transcend Medical and The FDA approved the Cypass procedure in conjunction with Cataract surgery in August of 2016 and is now available to the general public.
Sight Sciences VISCO360 Procedure in Canaloplasty
Many glaucoma surgeries today drain excess eye fluid creating a bulge of fluid under the surface of the white part of the eye. This bulge is called a “bleb” and sometimes involves placing a permanent implant. The Visco360 Procedure is a system intended to be used inside the eye to perform a procedure to aid in lowering your intraocular pressure.
The VISCO360 system is designed to help drain excess fluid from the eye without creating a bleb or requiring a permanent implant. The VISCO360 system will be used to inject an approved viscous liquid into a small canal at the front of your eye. This will open the canal with the goal of helping lower your eye pressure and control your glaucoma.
InnFocus Inc. MicroShunt®
The InnFocus Microshunt is a minimally invasive stand-alone procedure for mild, moderate, and severe stage open-angle glaucoma, with the potential to eliminate eye drop medications in most patients. Unlike many MIGS (micro-invasive glaucoma surgery) technologies, the InnFocus MicroShunt does not require simultaneous removal of the cataract.
ForSight VISION5/Allergan Ocular Insert
This ocular insert drug delivery system was acquired by Allergan pharmaceuticals in 2016 and is still undergoing clinical trials for efficacy. This is a non-invasive ocular ring insert that rests on the surface of the eye beneath the eyelid, to be inserted by an ophthalmologist or optometrist.
The ring releases a glaucoma drug and treats glaucoma over the course of multiple months by reducing the pressure in the eye. This type of drug delivery system enables it to be preservative-free and helps improve patient compliance since there is no need to administer drops daily.
For more information about whether you are an eligible candidate for a research study, talk to your doctor or call the glaucoma research department at Ophthalmology Associates in Fort Worth at 817-332-2020.
CURRENTLY ENROLLING 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.
- 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.
PAST CLINICAL TRIALS
- A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass Stent Model GTS400 using the G@-M-IS Injector System in Conjunction with Cataract Surgery [GC-008]
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.
- A Prospective, Randomized, Single-Masked, Comparative, Multicenter Clinical Study to Assess the Safety and Effectiveness of the Transcend CyPass Glaucoma Implant in Patients with Open-Angle Glaucoma Undergoing Cataract Surgery (COMPASS Study) [TMI-09-01 Extension]
- 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 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.
- 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.
- Alcon C-00-50 Phase IV Travatan in African Americans
- Allergan Mementine Phase III
- Alcon C-01-69 Phase III, Travatan/Timolol vs Travatan
- Alcon C-01-70 Phase III, Travatan/Timolol vs Travatan
- Allergan internet study
- Alcon ORA study
- Alcon Travalert C-04-69
- Pfizer Xalacom US Phase II