CLINICAL RESEARCH

What is a clinical trial?

A clinical trial (also called clinical research) is a research study involving human participants (or volunteers) to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work and ways to improve health.

Interventional trials determine whether investigational treatments or new ways of using known therapies are safe and effective under controlled environments.

Observational trials address health issues in large groups of people or populations in natural settings.

Participants in clinical trials can play a more active role in their own health care, gain access to new treatments before they are widely available, and help others by contributing to medical knowledge.

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain confidential and will not be mentioned in these reports.

Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure risks are kept as low as possible and are justified by the potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and technicians involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then the research team provides an Informed Consent Document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Potential risks and expected benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from a trial at any time.

1. Clinical trials are tests of medical treatments to make sure they are safe and effective.
2. Before you agree to take part in a study, you must be given complete information about the study, including possible side effects and benefits.
3. You must sign a special document called "Informed Consent" before taking part in the study.
4. You can leave the study at any time.

For more information about clinical trials that Drs. Fine, Hoffman and Packer are currently conducting contact our Clinical Research Director at 541-349-5186.

Cataract Studies

WaveTec Study (currently enrolling)
This study involves taking images of your eye with an aberrometer (a device used to measure irregularities of the eye) during cataract surgery. Information from this study is being used to develop a new aberrometer that may help enhance the visual results of cataract surgery.

LRI Study (currently enrolling)
For patients having astigmatism correction with cataract surgery. This study involves taking images of your eye at postoperative appointments. Information from this study is being used to determine the accuracy of astigmatism correction with limbal relaxing incisions (LRIs).

For more information: http://www.mastel.com/

Synchrony Accommodating IOL
The Synchrony® Dual Optic Accommodating IOL is currently being studied in patients to evaluate the safety and effectiveness of the lens, and the potential for functional near vision without glasses. The Synchrony lens is currently an investigational device within the U.S. and is not yet commercially available.

For more information  http://www.visiogen.com/

MEL80 High Myopia Study (currently enrolling)
Laser Vision Correction (LASIK) for patients with High Myopia (between –11.00 and –12.00 diopters of nearsightedness)

For more information: http://precisevision.zeiss.com/

MEL80 Mixed Astigmatism Study (currently enrolling)
Laser Vision Correction (LASIK) for patients with Mixed Astigmatism (astigmatism component of prescription is greater than spherical component)

For more information: http://precisevision.zeiss.com/

AcuFocus Study
Correction of presbyopia (reading vision) with the AcuFocus™ ACI 7000 implant (for patients who require reading correction only)

For more information: http://www.acufocus.com/

Contact Lens and Vision Research
We are currently seeking persons who may be eligible to participate in future contact lens and vision research studies directed toward the development and improvement of soft contact lenses.

To be eligible for participation in our contact lens and vision research studies the participant must be between the ages of 35 and 65 years old, currently wear soft contact lenses and have healthy, non-diseased eyes.