Six-month trial to test Fluidvision AIOL on patients after cataract surgery
POWERVISION Inc, a private medical device company, is sponsoring the ORION clinical study to evaluate the FluidVision Accommodating Intraocular Lens (AIOL). In the ORION study, patients will receive the FluidVision AIOL in one eye and a standard lens in the other eye.
ORION study description
This study will determine if the FluidVision AIOL allows patients who undergo cataract surgery, to see distant objects as clearly as with a standard lens, and also to see near objects more clearly than with a standard lens.
Eligible patients will receive a FluidVision AIOL in one eye and a standard lens, the Alcon AcrySof® IQ Monofocal IOL, in the other eye. Patients will be required to have seven follow-up visits over a six-month period after cataract surgery.
For this study, your eye surgeon will follow the approved clinical protocol for follow-up visits and for clinical measurements.
The FluidVision AIOL is an investigational device. This means that the safety and effectiveness of this device has not been proven. It has not been approved by the government for sale in South Africa.
What is a cataract and how it is usually treated?
With age, the natural crystalline lens within the eye may become opaque (cloudy) and no longer allows enough light to pass through to permit the eye to focus properly.
In traditional cataract surgery, the natural lens inside the eye is removed and replaced with an intraocular lens (IOL).
Conventional IOLs are monofocal lenses, meaning they are designed to provide good visual acuity at a single focal point, usually far away for good distance vision. Therefore, some patients may require reading glasses or contact lenses even after successful surgery in order to use a computer, read or perform other close-up tasks within arm’s length.
The FluidVision AIOL
The FluidVision AIOL is a soft, fluid-filled intraocular lens. The lens is designed to change its shape, just like the natural lens, becoming thicker when you need to see up close or thinner to see far away.
After cataract extraction, the FluidVision AIOL is implanted into the capsular bag like a conventional IOL.
Similar to traditional IOL surgery, the FluidVision AIOL can be removed or replaced.
What are the known risks?
The known risks associated with the implantation of the FluidVision AIOL are generally similar to those associated with cataract surgery using conventional IOLs.
Some examples of these risks include inflammation, infection or loss of clearness of the front portion of the eye. The same kind of risks are possible whether a FluidVision AIOL or a standard lens is inserted.
However, the risk level is higher for the FluidVision AIOL because it is larger than a standard lens. It is possible that your vision in the eye with the FluidVision AIOL may not improve or may improve only with the use of eyeglasses, contact lenses, or a laser vision correction procedure.
Your participating eye surgeon in the ORION study will further explain the study risks to you.
Ask your participating eye surgeon if you are a candidate for this clinical study and surgical procedure, and to further explain the risks and benefits associated with this type of FluidVision AIOL implantation.
Study eligibility criteria
Patients must meet all criteria to be entered into the study.
Key criteria for participants include:
- 50 years of age or older;
- Cataracts in both eyes and corrected distance visual acuity worse than 20/40 (or 6/12) in each eye;
- No other ocular conditions, degenerative visual disorders or systemic diseases
- No previous intra-ocular or corneal surgery in either eye;
- Not using medications that may affect accommodation;
- Willing and physically capable of wearing contact lenses, if required;
- Willing and able to comply with schedule for follow-up visits for six months after surgery
- Patient does not currently participate in any other clinical study for the eye
A complete list of inclusion/exclusion criteria is available at www.sanctr.gov.za. For more information on the ORION clinical study, call 087-550-5848 or contact your participating eye surgeon.
