Recruiting for Research Studies
Cincinnati Eye Institute is currently enrolling volunteers to participate in clinical research studies for adults with dry eyes, glaucoma, cataracts, iris defects, macular degeneration, ocular histoplasmosis, and diabetes. If you or someone you know is interested in clinical research, here is a sampling of the current research studies:
- Dry Eye Studies
- Corneal Disease Studies
- Artificial Iris Device Study (Congenital and Traumatic Aniridia)
- Glaucoma Drug and Device Studies (Ocular Hypertension and Open Angle Glaucoma)
- Cataract Studies
- Cataracts without any other ocular conditions
- Cataracts with Astigmatism
- Cataracts with Glaucoma
- Retinal Disease Medication and Treatment
- Inherited (Stargardt's Disease)
- Acquired (Diabetic Retinopathy, Macular Degeneration)
- Infectious (Histoplasmosis)
- Comparative Studies of Ocular Medications
- Pharmacologic Studies of Effects of Systemic Medications on Eyes
- Evaluation of New Diagnostic Testing Equipment in Clinic and Surgery
Qualified participants may receive health assessments and study related medical care. Reimbursement for your time and travel may be provided. Contact the Clinical Research department by calling 513-569-3688 or email at firstname.lastname@example.org.
Clinical Research is a voluntary activity. Please note that you should never feel pressured into participating in a clinical research study, and while you may be asked to return for additional safety visits, that you are able to discontinue a study at anytime without it affecting your medical care.
Eyesight is a precious gift. Daily we see hundreds of patients at CEI who have problems with their vision and hope to find a solution. CEI is known for the highest quality physicians, staff, and technology in ophthalmology. CEI has earned this reputation by embracing cutting edge technology and exploring new ideas.
Did you know that CEI’s physicians often have access to newest ophthalmic devices and pharmaceuticals because of the clinical research being conducted here? Currently there are about 30 different active research studies. Many of the sub-specialty departments have studies relative to their expertise. For example, in the Retina department there are AMD (Age-related Macular Degeneration) and DME (Diabetic Macular Edema) studies. In anterior segment there are iris reconstruction studies, multiple cataract and dry eye studies. The glaucoma doctors are active in studies for various glaucoma treatments. We even conduct studies that test the ocular effects of new systemic medications.
Clinical Research provides additional treatment therapies that may otherwise be inaccessible to our patients. CEI’s investigators and their research staff have been conducting clinical research for quite some time and have participated in approximately 200 studies. The area of research continues to improve and expand.
If a patient at CEI is involved in a study under another CEI doctor’s care, the provider may access the study for details, which becomes helpful in determining the best treatment course for the patient. Clinical Research is one more reason why the CEI doctors are the Leaders in Eye Care!
Frequently Asked Questions
The first priority is meeting your health care needs. As a research participant, your responsibilities are to:
- Provide a complete and accurate medical history.
- Follow the instructions and advice of your research team.
- Inform your research team if you do not understand information about the study.
- Communicate changes in your medical condition.
- Attend all follow-up study visits as required by the study protocol
Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of physicians, researchers, and members of the community. Its role is to make sure that the study is ethical and the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other things. The IRB also reviews the informed consent document.
Various Federal agencies, including the Office of Human Subjects Research Protection (OHRP) and FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.
If you are asked to participate in a research study, you want to make an informed decision about participating. It is important that you have a thorough understanding of the following elements of the research study:
- You should receive satisfactory answers to all of the questions that you have about the research.
- You should receive ample time to consider the study and make a decision on whether or not you wish to participate, without felling forced or required to participate.
- The study involves research.
- An explanation of the purposes of the research.
- The expected duration of your participation.
- A description of the procedures to be followed.
- Identification of any procedures which are experimental.
- A description of any reasonably foreseeable risks or discomforts to you.
- A description of any benefits to you or to others which may reasonably be expected from the research.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might e advantageous to the subject.
- A statement describing the extent, if any, to which confidentiality of records identifying you will be maintained.
- For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained.
- An explanation of whom to contact for answers to pertinent questions about the research and your rights as a research subject, and whom to contact in the event of a research-related injury to you.
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled, and you may discontinue participation at any time without penalty or loss of benefits, to which you are otherwise entitled.
- You will be given a signed and dated copy of the informed consent form.
Additional elements, as appropriate:
- A statement that the particular treatment or procedure may involve risk to you (or your embryo or fetus, if you are or become pregnant), which are currently unforeseeable.
- Anticipated circumstances under which your participation may be terminated by the investigator without regard to your consent.
- Any additional costs to you that may result from participation in the research.
- The consequences of your decision to withdraw from the research and procedures for orderly termination of participation by you.
- A statement that significant new findings developed during the course of the research, which may relate to your wiliness to continue participation, will be provided to you.
- The approximate number of subjects involved in the study.
For more information about research studies go to www.clinicaltrials.gov.