ECNC Logo

Clinical Studies

Clinical Studies

EYE CENTER OF NORTHERN COLORADO CLINICAL STUDIES

At Eye Center of Northern Colorado, we believe that clinical research helps us enrich and develop better treatment options for our patients. Our clinical research has also helped make significant strides in the understanding of eye diseases and how to better treat them.

Without contributions from our fantastic patients, improvement in ophthalmic research and care is impossible; the success of these clinical trials depends on patients like you. Working together, we have the opportunity to gain access to cutting-edge investigational treatments that are not yet available to the general public. In addition, we are contributing to medical advancements that will help generations to come.

LEARN MORE ABOUT OUR CLINICAL TRIALS

If you would like more information about participating in a clinical trial please see our clinical studies FAQ and/or contact our research department at:

Courtney Moon

Research Department Manager

Courtneym@eyecenternoco.com

(970) 419-2696

Or follow the link below to schedule an appointment

We are currently conducting trials on the following conditions:

GLAUCOMA & OCULAR HYPERTENSION STUDIES

Learn more about glaucoma, ocular hypertension, and the current FDA approved treatments available. Below is a list of clinical trials that Dr. Bashford, Dr. Apple, and Dr. Rains are involved in.

GLAUKOS TRAVOPROST INTRAOCULAR IMPLANT CLINICAL STUDY

(not actual size)

About the study…

The purpose of this clinical study is to evaluate the intraocular pressure (IOP)-lowering effect of two investigational implanted medication treatments, as compared to a control topical medication treatment.  It is designed to compare the results from three different groups of patients.  All three groups will receive treatment.  One group will receive the fast-releasing implant and drops, a second group will receive the slow-releasing implant and drops, and the third group will undergo a pretend surgery, (meaning the motions of a surgery will take place in the operating room but no surgery will take place) and receive only drops.

Will I receive the implant?

By participating in the clinical study, you will have a 100% chance of being treated with a medication, 2 in 3 chance (66%) of receiving the Travoprost Intraocular Implant and a 1 in 3 chance (33%) of receiving Timolol drops.  The study will require all patients to use a drop 2 times a day for the duration of the study.  The type of drop will be predicated by which arm of the study to which you are randomized.

Will the patient know if they got the implant?

Subjects will not know which treatment they are receiving until after the study is complete.  This is common practice in a clinical study to prevent or minimize the chance that knowledge of receiving the investigational product will influence your responses or expectations in the study.

Who can participate in this study?

This study is for patients with open-angle glaucoma and ocular hypertension (elevated intraocular pressure).

How long will the study last?

If you meet eligibility requirements during a screening and baseline exam, you will be scheduled for your study procedure.  Following the procedure, you will be required to complete 16 study visits over a 3-year period, which is only a few visits more than standard glaucoma care.  Visits need to be completed within specific intervals.  If you join the clinical study, the Travoprost Intraocular Implant, study drops–including Timolol — as well as all study visits and any specific examinations associated with the study (and eye studied), will be provided to you at no cost.

For more information on this study please see the resources below:

Glaukos Travopost Intraocular Implant on ClinicalTrials.gov 

GLAUKOS iStent infinite® CLINICAL STUDY

(not actual size)

About the study…

A tiny medical device called the iStent infinite Trabecular Micro-Bypass stent is being tested in an investigational study to help alleviate high eye pressure in patients with refractory glaucoma. The iStent infinite stents may help lower the pressure in your eye (intraocular pressure, or IOP). They do this by providing channels for fluid to move out of the front chamber of the eye. Less fluid in the chamber means lower pressure and this may be beneficial in managing your glaucoma.

The iStent infinite procedure consists of placing 3 stents in 3 separate locations in your eye, inserted through a small opening in your cornea. The iStent infinite stents are placed within the natural drainage canal of the eye and are implanted with the goal of lowering pressure. This is done by opening a passage into the existing drainage system that allows fluid to flow out.

How many people will receive the device?

All patients that meet specific study criteria and agree to be part of this study will receive the devices.

Who can participate in this study?

If you have had previous glaucoma surgery and been told by your eye doctor that your eye pressure is not well controlled by medications you are on, you may be able to participate in this clinical study.

How long will the study last?

If you meet eligibility requirements during a screening and baseline exam, you will be scheduled for your study procedure.  Following the procedure, you will be required to complete 6 study visits over a 12-month period.  During these visits, you will also complete a questionnaire and eye examination procedures, so that you and your physician can track your progress.

For more information on this study please see the resources below:

GLAUKOS iStent Infinite on ClinicalTrials.gov

Cataract Studies

Learn more about cataracts and the current FDA approved treatments available. Below you will find the clinical trial(s) Dr. Foster is participating in.

What is this device?

We are excited to be clinical investigators for the IC-8 lens clinical study. The clinical study is designed to evaluate if the IC-8 lens will provide far, intermediate and near vision for patients with cataracts.

The IC-8 lens is a clear monofocal lens with a mini-ring placed in the center. The mini-ring has an opening, or pinhole, designed to increase the range of vision by extending the focus of light rays that enter the eye.

Caution: Investigational Device. Limited by Federal (or United States) law to investigational use.

How many people will receive the device?

There are two ways patients may be able to participate in the clinical study:

  1. Test Group (IC-8 Lens Group) will have a standard monofocal lens implanted in the first eye. If visual requirements are met after the first lens is implanted, the IC-8 lens will be implanted into the other eye. The IC-8 lens is an investigational device and is being studied to determine if vision at all distances is clearer than with a standard monofocal lens in both eyes.
  2. Control Group (Monofocal Lens Group) will have a standard monofocal lens implanted in the first eye. If visual requirements are met, a standard monofocal lens will be implanted in the other eye. A standard monofocal lens is designed to provide far vision, but not near or intermediate vision.

The sponsor of this clinical trial plans to enroll 355 patients into the test group and approximately 120 subjects into the control group throughout the United States. Our office plans to enroll approximately 20 subjects in the test group and 7 in the control group.

Comparison of the two groups will help determine the improvement in vision with the IC-8 lens. Patients who participate in either group and comply with study commitments will be compensated.

Will the patient know if they got the device?

Both the doctor and participating patients will know if they receive the investigational lens or the monofocal lens. There will be some technicians that perform tests throughout the study that will not know which lens the patient receives.

Who can participate in this trial?

This is a study for patients that have visually significant cataracts (see worse than 20/40 with glasses) and are ready for cataract surgery.

How long with the trial last?

This clinical study will ask patients to complete 11-12 visits within a specified time frame over the course of 1 year.

For more information on this study please see the resources below:

www.ic8lensclinicalstudy.com

IC-8 Lens on ClinicalTrials.gov

RETINA STUDIES

Learn more about macular degeneration and the current FDA approved treatments available. Below is a list of clinical trials that Dr. Crews, Dr. Korotkin, and Dr. Asano are involved in.

We have an exciting new study for some patients with wet macular degeneration coming soon!

 COMING SOON

We will have more clinical studies starting in the near future. We will be looking for patients that have been diagnosed with the following conditions:

  • Cataracts (ready for cataract surgery)
  • Wet macular degeneration
  • Glaucoma

If you have one of these conditions and are interested in participating in a clinical study, please check back soon for more information.


CLINICAL STUDIES FAQs

Clinical Studies

Clinical studies are research trials that determine whether a medical treatment or device is safe and effective. Each study focuses on a specific disease and methods of how to better prevent, screen, diagnose, or treat the condition. A clinical study may also test how well medical treatments work and sometimes may evaluate whether the technology used is superior to existing technologies.
Patients typically choose to participate in a clinical study because they may benefit from new treatments or technologies being studied. Patients who participate also benefit from being a part of the future of ophthalmic treatments that may help generations to come.
Patients are expected to have eye exams and other tests, may need to take medications and/or undergo surgery, and will be asked to return for follow-up examinations which may vary depending on each clinical trial. The follow-up exams will help determine how well the treatment is working.
Patients are identified in clinical studies by study numbers instead of names. Personal information like names or addresses are not disclosed. The medical information thus collected with a study identification number will be available to the study sponsor and government oversight agencies that are involved in the evaluation of investigational devices and procedures.
The duration of a clinical study varies and may last a few weeks to a few years. The success of a clinical study often depends on monitoring outcomes over an extended period of time.
There may be benefits associated with participating in a clinical study, some include:
  • Access to a new treatment method that may not otherwise be available to the public
  • Highest quality of care from experts who closely monitor a patient’s medical condition during the study and may continue care after study is completed
  • New knowledge surrounding the studied disease state or technology that may help others
It’s important to remember that whether or not a new treatment will work cannot be determined ahead of time. There is always a chance a new treatment may not work better than an existing treatment, may not work at all, or may be harmful. Some clinical study treatments may also cause side effects; some serious enough to require medical attention. Talk to your doctor for more information on the possible side effects involved with a particular clinical study.
Patients will not be charged for study-related visits before and after surgery. However, insurance may be billed for some/all costs related to surgery and possibly post op medications; health insurances may or may not pay for these charges.
Before a clinical trial begins, researchers must obtain approval from the Institutional Review Board (IRB). It is their responsibility to make sure a patient's care and rights are protected. During a clinical trial, the doctor will closely monitor treatment(s) to see how it is working and if any side effects occur.
As a participant in a clinical study, patients have the right to:
  • Be informed about the study information and purpose
  • Be informed about the medications or devices used in the study
  • Have patient responsibilities thoroughly explained before and during the study
  • Have possible benefits, risks, dangers, and discomforts thoroughly explained before and during the study
  • Be informed of the benefits and drawbacks of alternative drugs or devices before and during the study
  • Be informed of medical treatment options should patients need medical attention due to a direct result of the clinical study
  • Have the opportunity to ask questions regarding the clinical study
  • Stop involvement with the clinical study at any time without affecting treatment in the future
  • Be given sufficient time to decide whether to participate in the study without feeling pressured
  • Maintain privacy by not having a participant’s name printed on the study
  • For studies involving different treatment groups, be informed of the treatment assignment once the study is complete
  • Be given a signed copy of their consent form
Potential risks, benefits, study duration and time considerations of being involved in clinical trials will be discussed with patients in advance and should be considered when choosing to enroll in a clinical study.  Ultimately, some patients are not able to fulfill the commitments of being involved in a clinical study and may choose to leave the clinical study.

 

Our Locations

Fort Collins at Prospect

1725 E. Prospect Rd.
Fort Collins, CO 80525

Fort Collins at Precision Center

3151 Precision Dr.
Fort Collins, CO 80528

Loveland at Skyline

2555 E. 13th St. Suite 225
Loveland, CO 80537

Loveland at Centerra

6125 Sky Pond Dr.
Loveland, CO 80538

Greeley at Fox Run

1701 61st Ave
Greeley, CO 80634

Send Us a Message