B+L's swept source OCT granted 510(k) clearance
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The Food and Drug Administration has granted 510(k) regulatory clearance for the Swept Source optical coherence tomography (OCT) imaging system and updated software for the Victus femtosecond laser platform, manufacturer Bausch + Lomb (Bridgewater, N.J.) said in a press release. The Swept Source OCT system "boasts high-resolution imaging of the entire procedure and can be used to drive incision depth and detail the architecture of arcuate incisions," B+L said. The system provides auto-recognition of key ocular landmarks, including the pupil, anterior capsule and posterior capsule, along with the capsule tilt compensation to maximize lens fragmentation.
The Victus system is approved for the creation of a corneal flap in patients undergoing LASIK surgery, anterior capsulotomy during cataract surgery, penetrating arcuate cuts/incisions in the cornea and laser-assisted lens fragmentation during cataract surgery.
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Therapath launches national ocular pathology program |
Therapath (New York) has launched a national ophthalmic pathology program, the company announced. At present, largely due to cost and limited interest in the field, organizations no longer provide board certification in ophthalmic pathology. However, Therapath's program is administered with pathologists who are board certified from the College of American Pathology along with fellowship training specifically in the field of ophthalmic pathology, the company said.
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Bioptigen granted $458K for OCT validation
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Bioptigen (Morrisville, N.C.) has been granted $458,000 "to support clinical validation of the company's optical coherence tomography (OCT) imaging system," the company announced.
The EnFocus Intrasurgical OCT system will provide 3D visualization simultaneous with and co-registered to images from surgical ophthalmic microscopes, Bioptigen said. The North Carolina Biotechnology Center award adds to the $1.72 million the company received last year from the National Eye Institute to develop the technology.
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Alphaeon, Tracey Technologies to co-promote i-Trace
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Alphaeon Corporation (Irvine, Calif.) and Tracey Technologies (Houston) will co-promote the next generation iTrace platform, the companies announced in a news release. The iTrace uses patented forward ray-tracing technology to measure quality of vision, helping clinicians to identify internal aberrations, Alphaeon said.
Alphaeon will begin marketing the next-generation platform this month.
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Avalanche Biotechnologies (Menlo Park, Calif.), a clinical-stage biotechnology company involved in gene therapy for ocular disorders, has announced its initial public offering (IPO). The company has targeted $59/share as its opening price, and will initially make almost 2.4 million shares available.
The company's lead product, AVA-101, is currently under development in a phase 2a trial for wet age-related macular degeneration. Avalanche's Ocular BioFactory platform technology is a proprietary adeno-associated virus (AAV)-based gene therapy discovery and development technology optimized for ophthalmology that utilizes a directed evolution approach to generate novel drug candidates.
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BioLight, Hebrew University form new alliance |
BioLight Life Sciences Investments (Tel Aviv) has licensed-in a drug-delivery technology platform designed to "enable more efficient and safer delivery of eye drops" from the Hebrew University in Israel. The two groups have formed a new company to develop the platform; BioLight will hold a 40% equity position.
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GRF honors OWL co-founder
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The Glaucoma Research Foundation (GRF, San Francisco) will honor Adrienne L. Graves, PhD, with the Catalyst Award, GRF's highest honor, the group announced.
Dr. Graves, one of the co-founders of Ophthalmic Women Leaders (OWL), is being recognized for her "visionary spirit and contributions as co-chair and co-founder of Glaucoma 360 New Horizons Forum and service to the GRF," the group said.
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RESEARCH BRIEFS
- Visual field (VF) impairment may impede reading performance even in glaucomatous patients with preserved visual acuity (VA), according to a study. R. Burton and colleagues measured silent reading speeds using nonscrolling text on a computer setup in 54 patients with glaucoma (mean age 70±8 years) and 38 visually healthy controls (mean age 66±9 years). Combined results of 3 cognitive tests and tests of VF, including the Humphrey 24-2 threshold VF test in each eye, produced binocular integrated VFs (IVFs). Regression analyses were conducted using the control group to correct for cognitive test scores, age and VA, and to obtain the IVF mean deviation (MD) and total deviation (TD) value from each IVF test location. Concordance between reading speed and TD was ranked in order of importance to explore the parts of the IVF most likely to be linked with reading speed. No significant association between IVF MD value and reading speed was observed (P=0.38). The inferior left section of the IVF was most often associated with reading speed. This study is published in the Japanese Journal of Ophthalmology.
- Cataract has been identified as the main cause of phakic intraocular lens (PIOL) explantation, especially in patients with posterior chamber PIOLs. In patients with angle-supported lenses, endothelial cell loss was the primary cause of explantation. Jorge L. Alió, MD, and colleagues retrospectively evaluated causes of PIOL explantations in 240 eyes (226 patients). There were 144 angle-supported lenses, 24 iris-fixated lenses, and 72 posterior chamber lens explantations. Patients' mean age at explantation was 46.30±11.84 years (range: 25 to 80 years). The mean time between implantation and explantation was 381.14±293.55 weeks: 8.10±5.52 years for the angle-supported group, 9.36±6.75 years for the iris-fixated group, and 4.49±4.25 years for the posterior chamber group. The time to explantation in the posterior chamber group was significantly shorter (P<.001) than it was in the other groups. The main causes of explantation were cataract formation (132 eyes, 55%), endothelial cell loss (26 eyes, 10.83%), corneal decompensation (22 eyes, 9.17%), PIOL dislocation/decentration (16 eyes, 6.67%), inadequate PIOL size or power (12 eyes, 5%), and pupil ovalization (10 cases, 4.17%). Cataract development was the main cause of PIOL explantation, accounting for 51.39% of angle-supported cases, 45.83% of iris-fixated cases, and 65.28% of posterior chamber cases. Endothelial cell loss was the cause of explantation in 15.97% of angle-supported PIOLs, 8.33% of iris-fixated PIOLs, and 1.39% of posterior chamber PIOLs. This study is published in the Journal of Refractive Surgery.
- Diffractive multifocal toric IOL implantation decreased refractive astigmatism to an acceptable range in eyes with moderate corneal astigmatism and provided useful visual acuity (≥20/40) at any distance and significantly better near and intermediate visual acuity than a monofocal toric IOL, according to a Japanese study. Ken Hayashi, MD, and colleagues conducted a prospective case control series on 66 eyes (33 patients) with preoperative corneal astigmatism between 0.75 D and 2.82 D that were scheduled for implantation of a diffractive multifocal toric IOL (ReSTOR SND1T, Alcon, Fort Worth, Texas) or monofocal toric IOL (AcrySof SN6AT, Alcon). Visual acuity at various distances, contrast visual acuity, and refractive outcomes were analyzed at 3 months postop. Mean refractive astigmatism decreased to 0.71 D in the multifocal group and 0.74 D in the monofocal group. The multifocal group achieved a significantly better mean monocular and binocular uncorrected and corrected near visual acuity at 0.3 m and intermediate visual acuity at 0.5 m (P≤.0011) compared with the monofocal group. At other distances, the uncorrected and corrected visual acuities were similar in both groups, except at 1.0 m. At high to moderate contrasts, binocular photopic and mesopic contrast visual acuity did not differ significantly between groups; however, acuities at low contrasts were worse in the multifocal group (P≤.0429). This study is published in the Journal of Cataract & Refractive Surgery.
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EyeWorld Weekly Update is edited by Stacy Majewicz and Michelle Dalton.
EyeWorld Weekly Update (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Friday, distributed by email, and posted live on Friday.
Medical Editors: David F. Chang, MD, chief medical editor; Bonnie An Henderson, MD, cataract editor; Clara C. Chan, MD, cornea editor; Reay H. Brown, MD, glaucoma editor; Eric D. Donnenfeld, MD, refractive editor; and John A. Vukich, MD, international editor For sponsorship opportunities or membership information, contact: ASCRS*ASOA * 4000 Legato Rd. * Suite 700 * Fairfax, VA 22033 * Phone: 703-591-2220 * Fax: 703-591-0614 * Email: ASCRSOpinions expressed in EyeWorld Weekly Update do not necessarily reflect those of ASCRS*ASOA. Mention of products or services does not constitute an endorsement by ASCRS*ASOA.
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