CAPSULAR TENSION RINGS: Still Waiting for Approval
They're helpful in certain cataract surgeries. This could be the year the FDA OKs them.
BY JERRY HELZNER, ASSOCIATE EDITOR

Everyone who knows anything about capsular tension rings agrees that they can be very helpful in the small percentage of cataract surgeries in which the patient has weakened or broken zonules. In fact, they've been routinely and safely used around the world for a decade to greatly reduce the possibility of such complications as vitreous loss, dislocation of the nucleus, and inability to implant an IOL.

Simply stated, capsular tension rings made of polymethylmethacrylate (PMMA) help to stabilize the capsular bag prior to cataract surgery and IOL implantation in patients who have compromised zonules. Such conditions as pseudoexfoliation, subluxated lenses, prior trauma, prior pars plana vitrectomy or Marfan's Syndrome have compromised the zonular structure of about 1 to 2% of all cataract surgery patients.

In the United States, surgeons who've implanted capsular tension rings in investigational studies applaud their value, and those who haven't been able to use them are increasingly voicing their displeasure that the FDA has yet to approve the device. The FDA itself believes it has been trying its best to expedite the approval process. But despite this almost-unanimous show of support, capsular tension rings haven't received FDA approval.

In this article, I'll explain why a safe and useful device that virtually no one opposes has run into so many obstacles. I'll also discuss why 2003 may prove to be the year when capsular tension rings finally win FDA approval.

Front and side views of the Morcher Capsular Tension Ring.

Inexperience Leads to Delays

To understand why the approval process has encountered roadblocks, it's important to know that this is a story of a foreign company having its first experience with the FDA, and that company's U.S. representative attempting to shepherd his first pre-market application (PMA) through the rigorous FDA approval process.

The capsular tension ring was invented in 1991 by Bernd Witschel, M.D., a German ophthalmologist. It was then successfully commercialized by Morcher GmbH, a German company with long experience in the manufacture of contact lenses and IOLs.

To begin the process of attaining FDA approval, Morcher enlisted I. Howard Fine, M.D., as chief medical monitor of a 2-year U.S. investigational study involving 11 surgeons at five "core" sites. The study was later expanded to encompass additional sites and a total of 54 surgeons. Morcher also chose Hillard "Hid" Welch, an importer of ophthalmic medical devices, as its U.S. representative to prepare the company's PMA for the FDA's Ophthalmic Devices Panel.

"I got involved in 1997," says Welch, a plain-speaking New Englander and Yale graduate. "The people at Morcher knew me and I had some experience with the FDA in obtaining 510k clearances for ophthalmic devices. However, I had never done a PMA before and I didn't handle the data the way the FDA wanted it. I take full responsibility for the mistakes I made."

Welch may be being too hard on himself. By all accounts, Morcher's inexperience with FDA requirements contributed to data collection and documentation problems. It also led to poor communication with the federal agency. Despite these problems, the FDA believes it was "very proactive" in helping Morcher to gain approval for its device.

"We expedited Morcher's PMA and have helped them extensively over the years, including meeting with them before the PMA was submitted and stepping table-by-table through the analyses that would be needed for their PMA," says Donna R. Lochner, chief of the intraocular and corneal implants branch of the FDA. "The FDA can't base its approval on testimonials from physicians, but rather we need a set of clinical data that meet the minimum requirements for demonstrating safety and effectiveness. While we continue to work with the company on their PMA, the FDA has allowed a number of physicians continued access to the investigational device."

	The Ophtec ring is shown here stabilizing the capsular bag.

When the FDA Ophthalmic Devices Panel met to review the Morcher Capsular Tension Ring in January of last year, it found the clinical data incomplete and insufficient. One frustrated panel member even characterized the data as "garbage."

Still, seeing the potential benefits of the ring, the panel recommended approval of the device with conditions.

"We've hired a person with extensive experience in handling PMAs and we've been working to provide the necessary information to the FDA," says Welch. "I'm very confident that the Morcher ring will be approved sometime this year."

Competition Emerges

But Morcher's stumble may well be Ophtec USA's opportunity. Ophtec, which is experienced in dealing with the FDA, developed its own capsular tension ring and began a clinical study in 2001.

"We should be ready to go to the FDA panel as early as May," says Rick McCarley, president of Ophtec USA. "If that happens, our device could be approved by late summer."

"The fact that the ring hasn't been approved yet is procedural more than anything else," says Dr. Fine. "There's no downside to the use of the ring."

The fact that two companies are now contending for approval, both moving forward in the process, should soon spell good news for the many cataract surgeons who've been waiting to use capsular tension rings. For them, approval can't come soon enough.