In traditional cataract surgery, the surgeon removes the clouded natural lens and replaces it with a synthetic intraocular lens (IOL), placing it into the capsular bag, a pouch that exists naturally in the eye. The surgeon holds the pouch open by adding a viscous material, and, upon completion of the surgery, removes that material and closes the capsular bag.
Now, new technologies have experts like William Trattler, MD, asking if it might be possible to keep the capsular bag open and use the space for innovation, beyond just holding an IOL.
Omega Ophthalmics designed the Gemini refractive capsule to address that question, and potentially to reduce the risk of patients receiving an IOL that doesn’t achieve satisfactory results. The capsule is a three-dimensional implant that goes into the capsular bag through a 2.2-mm incision, and keeps the bag open. It accepts a proprietary, exchangeable optic, and maintains an open space for drug delivery, biometric sensors, and additional lens technologies.
Risk versus Reward
Omega’s chief medical officer, Gary Wörtz, MD, who invented the device, has described the “great lens gamble,” explaining that IOL selection can include choices based on low risk and low reward, high risk and high reward, or the most desirable of course, low risk with high reward.
“As a surgeon I want to give my patients the best options; I love talking about extended depth of focus lenses and multifocal lenses, but I know a small percentage of patients will be unhappy, due to night vision complaints or being off target,” said Dr. Trattler, a member of Omega’s advisory board. “Patients are willing to take that risk if there is an opportunity for a high reward. But many surgeons feel that they don’t want to deal with the potential risk, so they’re going to go with a low-risk and low-reward scenario and just offer a monofocal lens.”
With the Gemini capsule inserted into the capsular bag, a standard multifocal or monofocal IOL can easily be placed into the capsule. In the future, a piggyback lens could be added, or the lens could be switched out for a different lens, thus reducing the risk for patients.
The Gemini’s three-dimensional design helps it to press up against the capsule, so there has been no fibrosis or capsular opacity so far in patients. To date, there have been 50 human implants and Omega is happy with the progress that it has made.
Because it’s three-dimensional, the Gemini refractive capsule holds its shape when it’s inserted, so it fills the bag and centers correctly. The platform the capsule creates provides a stabilizing effect for IOLs, making the Z-axis of the IOL more predictable as well.
The 3D shape may theoretically help reduce the chance of retinal detachment after uncomplicated cataract surgery by replacing capsular volume.
Not Just for IOLs
Dr. Trattler says that at 200 cubic millimeters, the capsular space is great real estate for other technologies, and the Gemini capsule can help utilize that space. In the future, drug-delivery devices or biometric sensors may be placed in the space, and updated as technology progresses. Improved IOLs potentially could be implanted, too, as they become available.
He discussed the possibilities of wireless sensors that can fit into the capsule to send frequent IOP readings so physicians can optimize glaucoma treatment, and the placement of a telescope into the space for patients who, years after successful surgery, develop age-related macular degeneration.