This year marks the 75th anniversary of Sir Harold Ridley’s invention of the IOL. Few other medical devices have had as dramatic an impact on global quality of life.

Paradigm shifts in lens design have occurred since the first IOL was developed. The first was the creation of an anterior chamber IOL. The second was a transition to in-the-bag designs with an increasing number of features ranging from foldability to toricity and multifocality to an extended depth of focus and light adjustable optics.

As lens technology has improved, refractive results have become increasingly accurate. Evolutions in lens design, however, have challenged surgeons’ ability to predict which patients will be able to tolerate inherent trade-offs such as glare, halos, and reduced contrast sensitivity. In a busy practice, having 1% to 2% of patients dissatisfied with their postoperative results can lead an ophthalmologist to abandon an IOL. This observation has led me to believe that the next paradigm shift in lens technology should be a reversible or exchangeable platform.

CAPSULAR COLLAPSE SYNDROME

A ubiquitous complication of cataract surgery is what I call capsular collapse syndrome—the loss of the lens capsule’s elasticity, volume, and transparency after cataract removal and IOL implantation. The syndrome negatively affects patients’ vision and options in three ways.

No. 1: Fibrosis

Capsular collapse syndrome can lead to capsular fibrosis, including anterior capsular opacification, posterior capsular opacification, and phimosis. Collapse triggers a fibrotic epithelial-mesenchymal transformation of the clear elastic capsular bag into opaque contractile tissue. Without capsular fibrosis, IOL exchange would be a routine procedure. With fibrosis, especially around the lens haptics, the risk of zonular loss and bag instability increases.

No. 2: Loss of Capsular Volume

The syndrome also reduces capsular volume, which introduces variability in the effective lens position, rendering predictions of postoperative refractive error imprecise. The loss of capsular volume also causes the vitreous cavity to expand, which increases the risk of posterior vitreous detachment, retinal tears, and retinal detachment. Additionally, reduced capsular volume can cause capsular striae to develop when the C haptics of a lens implant expand the diameter of the bag. A Maddox rod effect, a common source of frustration for patients during the early postoperative period, can occur 90º away from the striae.

No. 3: Loss of Accommodation

The lens capsule is the thickest basement membrane in the human body and plays a key role in the mechanism of accommodation. I believe the capsule is the elastic spring that provides the necessary counterbalance to the ciliary body and zonular forces. When the capsule is cut and collapses, the eye’s ability to change focus is reduced or eliminated. As a result, current IOL designs that enhance patients’ range of vision do so at the expense of visual quality.

A DIFFERENT APPROACH

Impetus

Patients choose an IOL that determines the quality and range of their vision for the rest of their lives without first testing the results, and the options for reversal are limited. Rarely can patients upgrade their IOL as designs evolve, and they are typically out of luck if they develop pathology that is incompatible with the lens they chose.

Twelve years ago, these concerns led me to contemplate the features I would want in an IOL if I could design it from scratch. My goal was to solve problems that had not been prioritized by the IOL industry. I came to realize that many of the optical features of current IOLs are excellent but that the capsular bag must be kept open to prevent capsular collapse syndrome. Rather than invent a new IOL, I therefore decided to create a platform to enhance the IOLs already on the market. The Omega Gemini Refractive Capsule (Omega Ophthalmics; Figure) was the result.

Design

Much as the inner tube of a tire keeps it from deflating, the Omega Gemini Refractive Capsule prevents the capsular bag from collapsing. The device has a symmetrical design, meaning there is no right side up or upside down. Its anterior and posterior aspects have a 6-mm opening. The device is 2 mm high and has a 9.65-mm diameter. It is made of the same silicone material that has been used for IOLs for decades. The implant is thin and elastic enough to be biologically inert and to fit through the smallest available lens injectors. It is inserted in the same way as an IOL. The process takes a few seconds.

During years of human testing, the current design has caused no adverse events. It fits snugly within the capsular bag and retains enough space for multiple IOLs and additional drugs or devices, as needed. Clinical trial results will be submitted for publication soon.

Utilization

I envision offering the Omega Gemini Refractive Capsule to every patient, not just those receiving premium IOLs. Many patients do not comprehend the value proposition of premium IOLs until after surgery, so preserving their future options for an upgrade would be wise. In individuals who choose a premium lens, I would routinely implant a Gemini Capsule at the time of cataract surgery. The device would facilitate an IOL exchange if the procedure becomes necessary. Moreover, the subset of these patients undergoing a refractive lens exchange may wish to avail themselves of superior IOL technology developed in the future, and the Gemini Capsule could give them that option by preserving the capsular space. Those who develop ocular pathology such as glaucoma and macular degeneration may benefit from the device because it would allow their multifocal IOLs to be removed and/or IOP sensors or drug-eluting devices to be implanted in the future.

CONCLUSION

Thanks to its thickness and lack of nerve endings and blood supply, the human lens capsule may be the best place in the body to hold a prosthetic device. This is supported by the successful implantation of more than 1 billion IOLs to date. My hope is that the Omega Gemini Refractive Capsule helps preserve this high-value real estate and leverage it to maintain human vision.