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Opchat Magazine Professional Matters Pages

Professional Matters Ophthalmology News, July to September 2017

For Optometry Section Click Here

FDA Approves iDesign Advanced WaveScan Studio System to Treat Hyperopia With and Without Astigmatism.
Bausch + Lomb Launches Fortifeye Capsular Tension Ring.
Review of artificial vision technologies showing that the Argus II bionic eye is fundable.

FDA Approves iDesign Advanced WaveScan Studio System to Treat Hyperopia With and Without Astigmatism.

July 2017

The FDA has approved a new indication for the Star S4 IR Excimer Laser System and iDesign System.

With the approval, the iDesign can be used for LASIK patients with hyperopia, with and without astigmatism.

In addition to myopia and mixed astigmatism, physicians can now treat hyperopia over a wide range of pupil sizes in patients who are 18 years and older. Capturing five different measurements in a single capture sequence – wavefront aberrometry, wavefront refraction, corneal topography, keratometry, and pupillometry – the iDesign System can help save time during the procedure.

"With its five-measurement capture sequence and high-definition sensor, the iDesign System creates an individualized treatment plan for each patient," Jay Pepose, MD, said in a Johnson & Johnson Vision news release.

"It’s now capable of treatment for a wider spectrum of patients who may have myopia, mixed astigmatism, or hyperopia. This broad range of treatment in one system will now offer more solutions to more patients."

Dr. Pepose served as a medical investigator for the clinical trial.

The new indication is for wavefront-guided LASIK for use in patients:

With hyperopia with and without astigmatism as measured by the iDesign System up to +4.00 D spherical equivalent, with up to 2.00 D cylinder;

With agreement between manifest refraction (adjusted for optical infinity) and the iDesign System refraction as follows:

Spherical Equivalent: Magnitude of the difference is less than 0.625 D;
Cylinder: Magnitude of the difference is less than or equal to 0.5 D;
18 years of age or olderWith refractive stability (a change of <.1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery)

Bausch + Lomb Launches Fortifeye Capsular Tension Ring.

July 2017

Bausch + Lomb announced the US launch of the FortifEYE capsular tension ring (CTR), a preloaded, sterile, nonoptical implant indicated for the stabilization of the crystalline lens capsule in the presence of weak or partially absent zonules in adult patients undergoing cataract extraction with intraocular lens implantation.

Conditions associated with weak or partially absent zonules may include primary zonular weakness (e.g., Marfan syndrome), secondary zonular weakness (e.g., trauma or vitrectomy), cases of zonulysis, cases of pseudoexfoliation, and cases of Weill-Marchesani syndrome.

“Capsular tension rings can play an important role in complex cataract cases, and they must be both effective and easy to use during these procedures,” Chuck Hess, vice president and general manager, U.S. Surgical, Bausch + Lomb, said in a company news release. “The FortifEYE CTR with preloaded single-use injector simplifies insertion allowing for safe, immediate preparation and use.”

The FortifEYE CTRs are sterile, nonoptical implants made up of one continuous piece of polymethyl methacrylate (PMMA), available in both clockwise (right-handed) and counterclockwise (left-handed) insertion options, and are available in a variety of diameters, including 10mm, 11mm, and 12mm (compressed).

CTRs have been shown to preserve the integrity of the capsular bag diameter, capsulorhexis size, and IOL shape, allowing for good anatomical IOL centration. CTRs also have been shown to be a safe and effective ancillary method to delay the incidence, onset, and magnitude of posterior capsular opacification and reduce postsurgical decentration and tilt to allow for excellent optical performance of multifocal and plate-haptic IOLs.

(news from Eyewiretoday)

Review of artificial vision technologies showing that the Argus II bionic eye is fundable.

July 2017

Currently under funding review by NHS England, this recently published review show that the technology provides sufficient cost savings and patient benefits to justify its funding by the NHS.

The review has been published by the RCO in their Eye Journal.

PE StangaThe pursuit is now on to improve artificial visual function. Two retinal implants appear the most likely to succeed in the future having undergone multicentre human trials: the Argus II electronic epiretinal device (Second Sight Medical Products, CA, USA) and Alpha-IMS electronic subretinal device (Retina Implant AG, Germany).

The trial results to date are encouraging with visual improvement and acceptable safety profiles reported for both devices.

At present, the visual function generated by either device does not offer high enough resolution or acuity for a patient to regain a fully functional life. Despite this, both devices not only have the potential, but have actually improved the vision-related quality of life in a significant number of patients implanted. With this in mind, the economic argument is clear. Provided device-life is long enough, its cost should be acceptable for the obtained improvement in the quality of life.

The aim of this Review Article is to assist those readers that may be considering offering any of these devices as a treatment for blindness in Retinitis Pigmentosa. Download and read the full Review Document here.


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