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Up Front | Oct 2014



LACS Did Not Outperform Routine Phaco

Preliminary results of the ESCRS/EUREQUO Femtosecond Laser-Assisted Cataract Surgery (FLACS) study showed that laser-assisted cataract surgery (LACS) is as good as routine phacoemulsification, but currently does not outperform it, Peter Barry, FRCS, said during the XXXII Congress of the ESCRS meeting in London.1

The FLACS study, funded entirely by the ESCRS without the participation of industry, represents the first time that the outcomes of LACS have been compared with the outcomes in matched patients undergoing routine phacoemulsification in terms of visual acuity, surgically induced astigmatism, complications, and biometric errors.

The ongoing study currently includes 2,022 patients from 16 centers in 10 countries who underwent LACS between December 2013 and August 2014 and 4,962 patients randomly selected from a pragmatic sampling of 100,000 patients enrolled in the EUREQUO study, a database that includes approximately 1.5 million patients who have undergone cataract surgery. To facilitate honest reporting, individual surgeons, clinics, and patients participating in the FLACS study are anonymous in the database, Dr. Barry said. Additionally, all surgeons had previously completed 50 LACS procedures in order to avoid bias from a learning curve.

Although the groups had a similar rate of intraoperative complications at 0.5% or less, more postoperative complications occurred in the FLACS group, Dr. Barry reported, with 3.2% of LACS patients and 1.8% of routine phaco patients experiencing a complication after surgery. Furthermore, there was a striking difference in premium IOL use between the groups, he said. In the LACS group, 39.6% of patients received a multifocal IOL and 6.5% received a toric IOL, compared with 0.3% and 0.2%, respectively, in the phaco group. This led to more patients with slightly better super-vision in the LACS group, he said.

“At the moment, I think we can conclude that, in its current state of infancy, femto cataract surgery is really as good as traditional phaco, but currently does not, by these measures, outperform it,” Dr. Barry said.

  1. Barry P. ESCRS/EUREQUO FLACS study. Paper presented at: the XXXII Congress of the European Society of Cataract & Refractive Surgeons; September 14, 2014; London.

Novaliq Reports Positive Results

In patients with mild to moderate dry eye disease (DED), NovaTears OTC eye drops (Novaliq) successfully demonstrated effectiveness and safety in relief of dry eye symptoms, according to a company news release.

The study included 30 patients with symptoms of mild to moderate DED. The primary objective was to confirm whether NovaTears was able to successfully lubricate the ocular surface, stabilize the tear film, and relieve adverse symptoms associated with DED.

The investigators found that tear film fluid and stability improved over the study period and tear osmolarity remained unchanged. A subjective DED questionnaire revealed that patient symptom severity decreased after use of NovaTears over a 5-to-7-week period. Corneal staining indicated less corneal damage after treatment. No changes were observed in visual acuity or intraocular pressure (IOP).

Combined ECP, Cataract Surgery: Greater Reduction in Glaucoma Meds Than Cataract Surgery Alone

In medically controlled open-angle glaucoma (OAG) patients with visually significant cataract, combined endoscopic cyclophotocoagulation (ECP) and cataract extraction resulted in lower IOP and a greater reduction in glaucoma medications than cataract extraction alone, according to a study in the Journal of Cataract & Refractive Surgery.1

Brian A. Francis, MD, MS, of Doheny Eye Institute, California, and colleagues conducted study of 160 patients with medically controlled OAG and visually significant cataracts. Patients were treated with either ECP and cataract extraction (study group) or cataract extraction alone (control group). The groups were matched in age and baseline IOP. Main outcome measures were the change in IOP and number of glaucoma medications. Secondary measures included visual acuity and postoperative complications.

In the study group (n=80), mean IOP decreased from 18.1 ±3 mm Hg at baseline to 16 ±2.8 mm Hg at 1 year and 16 ±3.3 mm Hg at 2 years. The number of glaucoma medications decreased from 1.5 ±0.8 at baseline to 0.4 ±0.7 (1 year and 2 years). In the control group (n=80), mean IOP was 18.1 ±3 mm Hg at baseline, 17.5 ±3.6 mm Hg at 1 year, and 17.3 ±3.2 mm Hg at 2 years. The mean number of glaucoma medications was 2.4 ±1, 1.8 ±1.2, and 2 ±1 at baseline and 1 and 2 years, respectively. The difference in IOP and medication reduction between the groups was statistically significant at all time points. Visual acuity outcomes and complication rates were similar between the groups.

  1. Francis BA, Berke SJ, Dustin L, Noecker R. Endoscopic cyclophotocoagulation combined with phacoemulsification versus phacoemulsification alone in medically controlled glaucoma. J Cataract Refract Surg. 2014;40(8):1313-1321.

AcuFocus IC-8 IOL Receives CE Mark

AcuFocus has received CE Mark approval for its IC-8 small-aperture IOL, according to a company news release.

The IC-8 is designed to improve visual quality across a broad range of vision for patients with presbyopia who undergo cataract surgery or refractive lens exchange. The IOL uses the same small-aperture effect as the Kamra inlay (AcuFocus), expanding the number of patients who can benefit from small-aperture optics, the company said.

AcuFocus plans to release the IC-8 IOL in selected European markets.

Zeiss Introduces New Products

At the ESCRS meeting, Carl Zeiss Meditec announced the launch of products for cataract and refractive surgery markets and an expansion of products in its diagnostic portfolio.

Among these products was the IOLMaster 700 with swept-source biometry. According to the company, the IOLMaster 700 makes irregular geometries of the eye, such as tilting of the lens axis or insufficient fixation during diagnosis, easier to identify. The device enables cataract surgeons to view the complete longitudinal section of the eye, from the cornea to the retina. The reference image option eliminates the need for manual pre- and intraoperative marking of the astigmatism axis on the patient’s eye before implantation of a toric IOL. The IOLMaster 700 will be available in Europe this fall and in other countries beginning in 2015.

Zeiss also released a new aspheric monofocal IOL, the CT Lucia, which features a C-loop design and a glisteningfree material. The lens incorporates the company’s aspheric aberration-correcting optics. With a 2-mm injector tip and heparin coating on the IOL surface, the IOL can be implanted through a small incision. Supplied in a fully preloaded injection system, the CT Lucia is available as a clear ultraviolet-blocking and a yellow blue-light filtering IOL.

Aditionally, Zeiss announced it has expanded its Essential Line diagnostic portfolio, adding products for objective refraction, an applanation tonometer, and the Visuplan noncontact tonometer. According to the company, these devices can be combined with one another or with existing systems via common practice management systems.

Schwind Announces PresbyMax Data, Previews New Products

Schwind eye-tech-solutions announced 6-month results of a multicenter study of PresbyMax Hybrid at the ESCRS meeting. The company also previewed new technologies that it said will be introduced in the future.

The PresbyMax Hybrid study included 372 eyes of 186 myopic, hyperopic, and emmetropic patients. Mean patient age was 53±6 years; all patients were observed for 6 months or longer postoperatively. Preoperative defocus ranged from -8.37 to 5.50 D. Astigmatism of up to 3.75 D was treated, and the planned addition was up to 2.75 D.

According to a company news release, 99% of patients achieved a distance BCVA of 20/20 or better, and 79% achieved 20/20 distance UCVA. All patients achieved a near BCVA of 0.1 logRAD or better, and 95% achieved 0.1 logRAD near UCVA. Seventy-nine percent of patients gained 3 or more Snellen lines of distance-corrected near visual acuity.

Schwind also presented the concept of a new product family, the Schwind Mobile Generation, with an aim to provide a high-speed, lightweight, and fully mobile 500-Hz excimer laser that will offer flexibility in use and cost-efficiency. The mobile 500-Hz excimer laser will be available at the beginning of 2016, Schwind announced. The company also announced the launch of Smart Pulse Technology for the Amaris excimer laser, which ensures that, immediately after ablation, corneal smoothness is achieved. This technology will be available at the beginning of 2015 for all Amaris laser systems.

TearScience Introduces LipiView II

At the ESCRS meeting, TearScience introduced the LipiView II Ocular Surface Interferometer to assist in the diagnosis of meibomian gland dysfunction (MGD).

LipiView II performs objective examination of lipid thickness, blink rate, and meibomian gland structure. The system images meibomian glands by simultaneously employing reflected and transilluminated light sources to provide high-definition structural meibomian gland images. LipiView II allows clinicians to select their preferred meibomian view from one of three modes to analyze gland structure and function and use high-resolution images to educate patients on their level of MGD.

LipiView II will be commercially available in Europe during the fourth quarter of 2014, with upgrade options available for current LipiView owners, the company said.

Oertli Launches OS4 Platform

At the ESCRS meeting, Oertli displayed its new surgery platform, the OS4, which can perform both anterior segment and vitreoretinal procedures.

The OS4 features a touchscreen and wireless pedal, allowing surgeon commands to reach the instrument in linear or dual-linear steering. According to Oertli, the OS4’s Twinvac dual-pump system ensures flow control and highprecision suction with every surgical step. The system’s easyPhaco technology in the anterior segment allows a fast and safe procedure, even with use of a sub–2-mm incision. In the posterior space, the Caliburn cannula system allows the removal of the vitreous body with a high degree of velocity and precision, with optimal lighting provided by color-variable LED-plus illuminators.

The OS4 is not yet commercially available. Oertli said it expects approval in Europe by the end of the year.

Geuder Launches Enhanced DMEK Implantation Cartridge

At the ESCRS meeting, Geuder AG introduced an implantation cartridge for Descemet membrane endothelial keratoplasty (DMEK), developed by Peter Szurman, MD, PhD, of Knappschaft-Augenklinik Sulzbach, Germany.

The cartridge ensures a contactless and atraumatic intake of the fragile Descemet lamella by smooth aspiration and gentle injection into the anterior chamber, the company said. Due to the tapered 1.6-mm opening of the cartridge, a minimal incision size for clear corneal transplantation of 2.4 to 2.75 mm can be achieved. Additionally, the transparency of the glass cartridge allows controlled positioning of the Descemet lamella during the injection.

In addition to the sterile implantation cartridge, a selection of instruments for the preparation of the donor and recipient eye and for implantation of the graft is available.

VSY Introduces Two IOLs

VSY Biotechnology introduced two new IOLs, the Enova Glistening-Free Hydrophobic IOL and the Acriva Reviol Tri-Ed, according to a company news release.

The water content of the Enova lens is 0.75%, providing excellent IOL stability and lower posterior capsular opacification formation, VSY Biotechnology said. The IOL’s haptics are specially designed to yield less zonular stress and better fixation in the capsular bag.

The Acriva Reviol Tri-Ed features diffractive zones designed to allow higher modular transfer function values and clear vision at all distances. Its active-diffractive optic provides maximum light transmission to the retina, and its balanced light distribution produces improved contrast sensitivity. It is fully pupil independent.

Both IOLs are available in Europe. A preloaded version of the Enova will be available soon, the news release said.

Haag-Streit Introduces the BX 900 LED Slit Lamp

Haag-Streit introduced the LED-powered BX 900 photographic slit lamp, according to a company news release.

The BX 900 LED illumination head delivers independent light for the slit and background, which can be continuously controlled by a single control panel, allowing users to adjust the illumination with one hand. The updated features are fully compatible with EyeSuite Imaging Software, and images of various formats can be activated via a dongle license code, the news release said.

Ophtec and i-Optics Announce Marketing Collaboration

In an effort to target the premium cataract and refractive market, Ophtec and i-Optics announced a marketing collaboration.

Ophtec and i-Optics will promote and sell the Cassini Corneal Shape Analyzer together with Ophtec’s advanced IOLs and ArtiLens products in targeted markets.

Alcon, Beaver-Visitec Announce Separate Acquisitions

Alcon has entered into an agreement to acquire WaveTec Vision, according to a company news release.

Alcon plans to integrate the ORA System into its existing cataract refractive suite. Upon closing, Alcon will acquire full rights to the ORA System and immediately begin the integration of the company into its surgical business franchise.

Likewise, Beaver-Visitec International has acquired Endo Optiks, the company announced in a news release. Endo Optiks is the manufacturer of the E2 combined laser and endoscopy system and the E4 endoscopy system. Terms of the transaction were not disclosed.

—Compiled by Steve Daily, News Director; and Callan Navitsky, Senior Editor