Ocular fixation, incision system elevates outcomes of surgery for presbyopia

Take-home message: Results are analyzed from a series of 28 patients who underwent bilateral scleral implant surgery for presbyopia using a new ocular fixation and incision system.

By Cheryl Guttman Krader; Reviewed by Barrie D. Soloway, MD

New York-A new ocular fixation and incision system is another step forward in improving visual outcomes of scleral implant surgery for presbyopia (VisAbility Procedure, Refocus Group), according to Barrie D. Soloway, MD.

The system enables increased consistency of scleral tunnel architecture by providing fixation, docking, and incision guidance. With its use, more patients are achieving J3 or better distance-corrected near visual acuity (DCNVA) and sooner after their surgery.

“Since the scleral implant procedure for presbyopia was first introduced, there have been a series of refinements in implant design, instrumentation, and surgical technique that have standardized and simplified the surgery and led to better results,” said Dr. Soloway, director, New York Eye and Ear Infirmary Vision Correction Center, and assistant professor of ophthalmology, New York Medical College, New York.

“As the latest advancement, the ocular fixation device makes the procedure faster and easier,” he said. “In addition, it assures secure, uncomplicated, and consistent placement of the scleral implants. These advantages appear to translate into clinically superior outcomes.”

How it works

The docking station fixes at the limbus, holds the eye steady, and eliminates the need for manual marking of the scleral tunnel sites. Once the docking station is in place, the proprietary scleratome is used to create the four tunnels, which will be uniform in their position (4 mm from the limbus), length (4 mm), and depth (400 µm).

With the docking station still in place, the shuttle assembly is threaded through each tunnel, and then each PMMA implant is placed and locked into position.

Data analysis

Outcomes from procedures performed with the ocular fixation and incision system were analyzed using data from 56 eyes of 28 patients who underwent the binocular procedure in Europe. Already at 1 month after surgery, near DCNVA was J3 or better in 73% of eyes monocularly, and the proportion of eyes achieving that outcome increased to 87% at 3 months and 93% at 6 months.

Binocular DCNVA was even better with 96% of patients in the European cohort reading J3 or better among seen at 3 months.

Those results were compared with outcomes from eyes enrolled in the U.S. IDE study, which were operated on with an earlier-generation scleratome and without the ocular fixation device. In the U.S. IDE cohort, only 64% of eyes achieved J3 or better DCNVA at 1 month. The proportion achieving that outcome continued to increase as follow-up lengthened.

However, it still only reached 76% at 6 months, Dr. Soloway noted.

Benefits of novel concept

The scleral implant procedure is intended to improve near vision in presbyopic emmetropes by expanding scleral tissue around the lens, thereby increasing the circumlental space and restoring physiological conditions necessary for accommodation.

Relative to other surgical modalities for presbyopia, the scleral implant procedure has several attractive attributes, according to Dr. Soloway.

“The scleral implant surgery is a reversible, binocular, extraocular procedure that is performed outside the visual axis,” he said. “Unlike monovision or multifocal procedures it does not affect distance vision and it affords patients a full range of vision from far through intermediate to near.”

In addition, it has been associated with a favorable safety profile as there have been few ocular adverse events and no reports of ocular disturbances such as halos or starbursts that can occur with multifocal IOLs, Dr. Soloway said.

Barrie D. Soloway, MD

E: bds@ihateglasses.com

Dr. Soloway is medical director for Refocus Group and a paid consultant.