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Rayner, the maker of the world's first IOL, now wants to set a new standard with the Centerflex™ lens, which it hopes will help the company re-establish itself in the biggest market for IOLs - the US.

In so doing, Rayner officials hope to capitalise on a history of design and manufacturing that was well established when Harold Ridley approached the British company more than 50 years ago about his history-making IOL idea.

"In two or three years, we hope that a new generation of Rayner lenses will be sold in the United States," says Donald Munro, Rayner's Managing Director.
But just as Harold Ridley had an uphill battle to persuade ophthalmologists to insert a piece of perspex to replace the natural lens of the eye, so too has Rayner a challenge to sell Centerflex™ to thousands of American ophthalmologists who have never used
Rayner products.

Once a household name in America
Two decades ago, however, Rayner was a household name for US ophthalmologists. On December 11th 1981, two Rayner IOLs, the Choyce MkVIII and Choyce MkIX, became the first to be approved as "safe and effective" for clinical use by the US Food and Drug Administration. As a result, Rayner's production procedures became the benchmark for all IOLs.

As now, IOLs in the 1980s were constantly being improved and modified to suit surgeons' increasing demands and clinical knowledge. Every small modification to the lens, alteration of lens material or placement of the IOL required lengthy and expensive clinical trials for FDA approval.

Faced with these expenses and delays, Rayner decided to concentrate their efforts on European markets and ceased applying for FDA approval for the company's IOLs.
However, the decision meant that as US surgeons moved from routinely using the Choyce lenses to using PCIOL designs, they moved to using lenses from domestic, start-up IOL manufacturers. And as a result, Rayner lost its place in the US market.

"Although that decision may be considered a mistake now, I can understand the thought-processes of the management at the time," Mr Munro explains.
The cost of regulation wasn't the only obstacle for Rayner in the early 1980s. The pioneering company still faced opposition to the use of implants from the ophthalmic profession. In the 1980s, IOL implantation was a minority activity. Some heads of departments of large institutions in western Europe and North America considered IOL implantation a risky procedure and one to be avoided.

Rayner now set to return to US market
But, some 20 years later, Rayner is back. And the professional mood of ophthalmologists has, of course, changed too.
This year, ophthalmologists will implant Centerflex™ at a number of investigational sites in the US. Results from those centres, plus the medical evidence already coming out of three centres in Europe - Scarborough in the UK, Heidelberg in Germany and Vienna in Austria - will ultimately be presented to the FDA as part of the approval process.
"FDA approval is a tremendous goal for the company," Mr Munro says.
"Many American surgeons still remember Rayner from their days as residents and are curious to try Centerflex™."

There's history behind the Centerflex
When American ophthalmologists consider the Centerflex™ lens, Mr Munro hopes that while it may be new to them, they will remember the history that helped produce it.
In fact, when Ridley approached Rayner about his novel IOL idea, Rayner was already a well-established company. Two opticians, John Baptiste Reiner and Charles Keeler, opened their first shop in London in 1910 as Reiner & Keeler.

To overcome the anti-German sentiment among many Britons during the First World War, the company anglicised its name. By then, with a reputation for making high quality glazing for prescription spectacles, the company was an obvious choice for the British Armed Forces to manufacture optical instruments for the western front.
After the war, with the departure of Charles Keeler, the Rayner Optical Company relocated to Brighton, on the Sussex coast. The skills that produced the wartime gun-sights and trench periscopes were to play an important role in the company after World War II, when Ridley approached the company about his IOL.

More than 50 years of innovation
Ridley's first implant at St Thomas' Hospital in London marked the beginning of a long-lasting relationship between Rayner and pioneering ophthalmic surgeons. In the 1950s, US surgeons Warren Reese MD, and Turgut Hamdi MD, implanted Rayner Ridley IOLs at the Wills Eye Hospital.

With the creation of the "Intraocular Implant Club," and the growing acceptance of the IOL procedure worldwide, Rayner developed, perfected and sold its lenses all over the world during the next 50 years.

Today, Rayner remains family-owned and Brighton-based, but it has expanded. The development of close collaborations with ophthalmic surgeons is an approach that Rayner is proud to maintain.
"The company has developed excellent relations with many surgeons over the years," Mr Munro says. "And we listen to them."

After its head start with the world's first IOL, Rayner maintained its position as a pioneering manufacturer through the 1950s, 1960s and 1970s.
The most recent lenses, introduced to the European market during the 1990s, include: the Rayflex™, a silicone foldable IOL introduced in 1997; the Raysoft™, a hydrophilic acrylic IOL in 1998; and the landmark Centerflex™, a hydrophilic acrylic IOL in 1999.

Over the same period, the company introduced a viscoelastic solution, a range of titanium surgical instruments and their range of disposable ophthalmic knives.

The art of selecting a materials manufacturer
According to Rayner, three factors are crucial to the manufacturing of a good IOL: design, material and production.
Although a lot of importance has been given recently to the design, the other two issues are growing in importance to surgeons, says John Wells, Rayner's UK & Ireland Sales Manager.

"Good design is made evident by the dioptric accuracy, while good material and good production need time to prove their value," Mr Wells says.
"And it is the combination that gets excellent results," adds Mr Munro. "We are confident that the material we are using - Rayacryl™ - is very safe. It has been used for IOLs now for five years, without a single reported case of calcification."

Mr Munro observes that it is a common mistake to group together all acrylic materials, whether "hydrophilic" or "hydrophobic," as if these materials are homogeneous.
Such simple categorisation is dated. In the 1980s, PMMA lenses were all composed of material made by one or two manufacturers of good reputation, especially Perspex CQ™ from ICI.

"Rayner took a great deal of care in the 1940s to find a reputable supplier of quality PMMA - that was ICI," explains Mr Munro.
"And we took similar care in the 1990s when we were looking for material for our foldable lenses."

Materials for IOLs must be suitable
Currently, materials are a cause for concern, says Mr Munro. Many manufacturers supply hydrophilic and hydrophobic materials for IOLs, compared to one supplier of PMMA. These manufacturers make the material to different laboratory standards, Mr Munro observes.

"Many manufacturers come from the contact lenses background, and I suspect, most made relatively small alterations to their production techniques to produce IOLs," he says. "And some of the materials used in the past were not suitable for IOLs."
When Rayner reviewed available manufacturers a few years ago, it selected its supplier with great care.

"Because there is such great variation in the manufacturing processes, we decided to stick with a single company of proven high quality," Mr Munro stresses.

The future is injectable
Given its commitment to constantly improve products, Rayner is making innovative modifications to Centerflex™ to make toric and multifocal lenses. Although reluctant to give details, Mr Munro acknowledges that future strategic plans are focusing on a holistic approach that includes lens design, folding and delivery systems.

A lens injection system through a 2.8 mm incision is already available for Centerflex™ but that too is evolving. The company's aim is to develop a single-use disposable injection system for small incision with a pre-loaded lens.
With Centerflex™ and such ideas, Mr Munro is confident that increasing numbers of ophthalmologists worldwide will chose Rayner for their patients.
"We are receiving extremely good feedback from surgeons using the lens," he says. "We know we have a winner with Centerflex™."

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