November 10, 2015
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Novel add-on IOL may improve near visual acuity in advanced maculopathy patients

The Scharioth Macula Lens can be implanted in pseudophakic eyes or during cataract surgery.

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A novel add-on IOL may improve near visual acuity in patients with advanced maculopathy and pseudophakic lens status, according to a study.

The Scharioth Macula Lens (Medicontur), derived from the concept of sulcus fixation in pseudophakic eyes, was developed for sufficient magnification at a reduced reading distance.

Although various magnifying systems are available, most are not widely accepted because of low efficiency and high complication rates, cost and learning curve. Furthermore, almost all solutions require the eye to be phakic, with the systems implanted during cataract surgery.

“There are other implantable magnifying IOL systems, but except for the OriLens (OptoLight), all need to be implanted during cataract surgery,” inventor Gabor B. Scharioth, MD, PhD, told Ocular Surgery News. “But about two-thirds of patients with advanced maculopathy are already pseudophakic. Our add-on IOL is specially designed so that it can be implanted in pseudophakic eyes or during cataract surgery.”

In the Journal of Cataract and Refractive Surgery, Scharioth reported results from the first eight patients in which the add-on IOL was implanted.

Gabor B. Scharioth

Design and technique

The hydrophilic acrylic add-on IOL has an overall diameter of 13 mm with four symmetric haptics. It can be implanted during uncomplicated standard phacoemulsification with an in-the-bag posterior chamber IOL or years after cataract surgery.

“The special haptic design and the polished round edges prevent iris chafing and/or iris capture,” Scharioth said. “The patented haptic design allows perfect centration and prevents direct contact of the add-on IOL and the in-the-bag IOL.”

A 2.2-mm incision is made, and the anterior chamber is filled with an ophthalmic viscosurgical device. The lens is then placed so that it folds upward in the cartridge in order to control intraocular unfolding during implantation, the study said.

As the IOL unfolds, a second instrument is used through the side-port incision to guide the leading haptic into the ciliary sulcus. The remaining haptics are placed in a second step before the OVD is removed and the incisions are hydrated.

Results

In seven patients, uncorrected near visual acuity at 15 cm and corrected near visual acuity improved. Corrected near visual acuity improved by 4.4 lines with the macular add-on IOL at 15 cm as compared with +2.5 D of correction at 40 cm, and by 2.1 lines with the macular add-on IOL at 15 cm as compared with +6 D of correction at 15 cm.

“To select the best candidates, we perform a simple preoperative test. If near vision improves from 40 cm with 2.5 D to 15 cm with +6 D and the patient is motivated, he shall be a good candidate,” Scharioth said.

The one patient without improvement had advanced age-related macular degeneration with a large area of retinal pigment epithelial atrophy of the posterior pole.

No patient had a postoperative decrease in corrected distance visual acuity, and no intraoperative or postoperative complications occurred.

A European multicenter study, with 15 participating eye centers, is currently collecting more data in patients with AMD and best corrected visual acuity between 0.1 and 0.3. The add-on IOL has also been used in patients with other forms of maculopathy, such as advanced diabetic maculopathy and myopic maculopathy, and after membrane peeling in vitreomacular traction syndrome.

“It is always a long way from an idea to its first clinical use,” Scharioth said. “It was a fantastic moment when we implanted the first Scharioth Macula Lens in September 2013, and only a few days later our patient could read without the help of external low vision aids. I hope that this new option in our armamentarium to help patients with advanced maculopathy will help many patients to become more independent and self-confident again.” – by Kristie L. Kahl

Disclosure: Scharioth reports he is the inventor of the Scharioth Macula Lens and receives royalties from Medicontur.