Ophthalmic Research
Developing More Effective Research and Care
At Oklahoma Eye Surgeons, we believe that ongoing ophthalmic research helps us enrich our quality of care and develop better treatment options for our patients. Our participation in clinical research allows us to make significant strides in gaining a clearer understanding of eye diseases while discovering new and better ways to treat them.
Our clinical research participants make our goal of improving ophthalmic research and vision care achievable. Together, we have the opportunity to access new research treatments not yet available to the public. As a result, we can contribute to medical advancements that will help for generations to come.
Join our practice, and together, our physicians, research personnel, scientists, and a range of experts will take the essential steps to develop treatments that transform ocular therapies for patients all around the world. For more information about participating in ophthalmic research, please contact us.
Phone
(405) 943-4413
Press 5 for Clinical Trials
Mailing Address
Oklahoma Eye Surgeons
Dept. of Research & Clinical Trials
5600 N. Portland Ave.
Oklahoma City, OK, 73112
Enrolling Clinical Trials
Conditions: Cataract, Glaucoma, Ocular Hypertension
A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety and Efficacy of the Bimatoprost Implant System (78 mcg) Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%,
Brief Summary
This trial is a randomized study to evaluate the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.
Intervention / Treatment
- Drug: Bimatoprost Implant System
- Device: SpyGlass IOL
- Drug: Timolol Maleate Ophthalmic Solution, 0.5%
- Device: Commercial IOL
Multicenter, Randomized, Double-masked, Parallel Group Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intracameral Implant) in Conjunction With Cataract Surgery vs. Cataract Surgery Alone
Brief Summary
This trial will evaluate the safety and IOP-lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone
Intervention / Treatment
- Combination Product: iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
- Procedure: Sham procedure in conjunction with cataract surgery
Conditions: Glaucoma, Ocular Hypertension
Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
Brief Summary
Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
Intervention / Treatment
- Drug: Gen 2 Travoprost Intracameral Implant
- Drug: Timolol eye drops 0.5%
- Procedure: Sham Procedure
- Other: Placebo eye drops
A Phase 1/2 Study to Evaluate the Safety and Efficacy of AGN-193408 SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
Brief Summary
This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-groups (Cohort 2) and (Cohort 3) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension
Intervention / Treatment
- Drug: AGN-193408 SR
- Other: Lumigan
- Other: Sham Administration
- Other: Lumigan Vehicle
- Drug: AGN-193408 SR
- Other: Sham Administration
- Other: Lumigan Vehicle
Conditions: Glaucoma
A Prospective, Multicenter Study of the Glaukos® iStent Infinite Trabecular Micro-Bypass System Model iS3 in Subjects With Mild to Moderate Primary Open-angle Glaucoma
Brief Summary
Prospective, multicenter, single-arm study of the iStent infinite in adult pseudophakic or phakic subjects with mild to moderate primary open angle glaucoma who have not failed conventional medical and surgical treatment
Conditions
Glaucoma
Intervention / Treatment
- Device: iStent Infinite
A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Subjects With Glaucoma
Brief Summary
XEN63 is an investigational device for the treatment of intraocular pressure (IOP) in patients with glaucoma when both medical and conventional surgical treatments have failed (for US approval) and when medical treatments have failed (for outside US [OUS] approval). Participants will be placed in one of two groups called study arms. One group will receive the XEN63 gel stent ab interno (inside the eye) and the other group will receive the XEN63 gel stent ab externo (outside the eye). Approximately 130 participants aged 45 years or older with glaucoma will be enrolled in this study at approximately 32 sites in the United States.
Conditions
Primary Open Angle Glaucoma
Intervention / Treatment
- Device: XEN63 Glaucoma Treatment System
Active Clinical Trials
Conditions: Glaucoma
Multicenter, Randomized, Double-masked Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With the Placement of iStent Infinite vs. iStent Infinite Alone in Subjects With Open-angle Glaucoma or Ocular Hypertension
Brief Summary
Adult subjects with elevated intraocular pressure who have successfully undergone placement of iStent infinite trabecular bypass system will be randomized to receive a travoprost intraocular implant or receive a sham procedure and be followed for 12 months.
Intervention / Treatment
- Drug: Travoprost Intraocular Implant
- Other: Sham procedure
- Device: iStent infinite
A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Ab Externo Implantation of Glaucoma Gel Stent
Brief Summary
XEN45 is an approved device for the treatment of glaucoma implanted using the ab interno approach (inside the eye). XEN45 implanted using the ab externo approach (outside the eye) is being studied in this study. Approximately 65 participants aged 45 years or older with open-angle glaucoma will be enrolled in this study at approximately 22 sites in the United States.
Participants will attend regular visits during the study at a hospital or clinic. The safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations.
Conditions
Open-Angle Glaucoma
Intervention / Treatment
- Device: XEN45 (Glaucoma Gel Stent)
A Prospective, Multicenter, Clinical Trial Designed to Evaluate the Safety and Feasibility of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma as a Standalone Procedure
Brief Summary
Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle glaucoma (POAG)
Conditions
Glaucoma, Primary Open Angle
Intervention / Treatment
- Device: ELIOS Procedure
Ophthalmic Research FAQs
What is a clinical study?
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 explores methods to better prevent, screen, diagnose, or treat the condition. These studies help researchers determine how well medical treatments work and whether the technology used in the trial is superior to existing technologies.
Some clinical studies involve new treatments that are still being evaluated, while others test FDA-approved medications or procedures to assess their efficacy, longevity, and potential side effects when combined with other treatments.
Why participate in a clinical study?
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.
What is expected of patients who participate in clinical research?
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 study. The follow-up exams will help determine how well the treatment is working.
Is study participant medical information kept confidential?
Patients are identified in clinical studies by study numbers instead of names. Personal information like names or addresses are not disclosed.
Medication information will only be collected through the study identification number, which will be to the study sponsor and government oversight agencies that are involved in the evaluation of investigational devices and procedures.
How long will the clinical study last?
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.
What are the benefits of participating in a clinical study?
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.
- The highest quality of care from experts who closely monitor a patient’s medical condition during the study and may continue care after the study is completed.
- New knowledge surrounding the studied disease state or technology that may help others.
What are the risks involved in a clinical study?
It is 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.
Will my insurance cover costs related to being involved in clinical research, or will I need to cover any costs?
Patients will not be charged for study-related visits before and after surgery. Patients typically have no out-of-pocket expenses for the study device or the study procedure. Patients and their insurance company may be billed in the usual manner for the costs of medications; health insurance may or may not pay for these charges.
Before agreeing to be in a clinical study that has associated costs, patients should contact their healthcare payer/insurer to see if their plan will cover these costs.
How is a patient’s safety protected while participating in a clinical study?
Before a clinical study begins, researchers must obtain approval from the Institutional Review Board (IRB), whose responsibility it is to protect a patient’s care and rights. During the clinical study, doctors will closely monitor a patient’s treatment to see how it is working and if any side effects occur.
What are a patient’s rights in a clinical study?
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.
Can participants in clinical studies choose to quit the clinical study?
Potential risks, benefits, study duration, and time considerations of being involved in clinical research 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.