At Press Time
IFIS Awareness Improved Outcomes
After April 2005 warning, surgeons could combat IFIS.
■ A study of a large number of cataract surgery patients who had their procedures at the Veterans Affairs New York Harbor Healthcare System between 2000 and 2010 included two large cohorts of patients. One group took alpha receptor agonists (such as Flomax) — and then had their surgery — prior to the identification of intraoperative floppy iris syndrome (IFIS) in mid-2005. Another large cohort took alpha receptor agonists but had their procedure after warnings about IFIS were widely disseminated.
The study sought to determine if outcomes for these resident-performed procedures improved once the surgeons were aware of the link between alpha receptor agonists and IFIS.
Researchers from the VA Medical Center and Columbia University found that being able to identify those patients who had taken alpha receptor agonists prior to surgery and being aware of the potential for IFIS did improve overall outcomes. The results showed that vitreous loss was 11.6% in the cohort operated on prior to May 1, 2005, and only 3.5% in the group operated on after May 1, 2005. The probability of achieving a BCVA of 20/40 or better in the postoperative period was 82.7% (178/215) in the earlier group vs. 88.1% (201/228) in the later group.
The researchers concluded “we believe that the improved outcomes are a result of heightened awareness of intraoperative floppy iris syndrome, implementation of IFIS prophylaxis techniques including preoperative atropine, intracameral epinephrine, the use of iris stabilization devices (such as iris hooks and Malyugin rings) and improved phacoemulsification techniques. The description of IFIS and implementation of prophylactic measures have resulted in improved outcomes in resident performed phacoemulsification in patients exposed to alpha receptor blockers.”
IFIS is characterized by iris billowing, prolapse to phaco and side port incisions, and progressive miosis during phaco.
IFIS was first identified by the highly respected cataract surgeons Drs. David F. Chang and John Campbell in an article published in the Journal of Cataract and Refractive Surgery in April 2005.
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■ Sustained-release glaucoma medications. How soon? In what could be a preview of the future of how glaucoma medications are delivered, chemical engineers and ophthalmologists at the University of Pittsburgh have demonstrated that microparticles loaded with brimonidine tartrate can be implanted into the eyes of rabbits through subconjunctival injection and deliver a steady therapeutic dose of medication for a period of 28 days. The researchers, who presented at ARVO 2012, found no incidents of irritation or infection. They plan to build upon these results to develop a clinically relevant dosage form. Though not associated with this study, Allergan has also reported progress in developing a sustained-release format for delivering glaucoma medications. ■ LensAR receives FDA approvals. LensAR has received a 510(k) clearance from the FDA for the company's next-generation, commercial LensAR Laser System for use in femto-phaco. This regulatory clearance covers the use of LensAR's system for anterior capsulotomy, with and without laser phacofragmentation during cataract surgery. With this clearance now received, the company is now in final preparations for formal commercial launch of the system in the US. ■ DSAEK inserter saves endothelial cells. Researchers led by Lorena Riveroll-Hannush of Newtown, Pa., set out to compare the use of the Neusidl Corneal Inserter (NCI) as opposed to forceps in DSAEK in terms of endothelial cell loss at three months, six months, one year and two years. Forceps were used for insertion in 284 eyes and the NCI was used in 171 eyes. Preoperative endothelial cell counts for all donor tissue was provided by the eye banks. At all time points, use of the NCI resulted in approximately 20% to 23% less endothelial cell loss than use of forceps. This data was reported at ARVO. The researchers concluded that “corneal endothelial cell loss in donor grafts during DSAEK with the NCI is less than with traditional forceps insertion. The NCI insertion technique involves less tissue manipulation and appears to avoid crush injury compared to forceps insertion.” |
The “Myth” of Thin DSAEK Grafts
Thicker grafts produced similar visual outcomes.
■ A large study led by the highly respected corneal transplant pioneer Mark A. Terry, MD, of the Devers Eye Institute, Portland, Ore., goes a long way to debunk the somewhat widespread belief that “thin” and “ultra-thin” DSAEK grafts produce superior visual outcomes.
The researchers' goal in conducting the study of 356 eyes was to determine if preoperative graft thickness influences visual results after DSAEK. This was the largest study of this issue ever reported and was presented at the recent ARVO meeting.
The researchers compiled data on DSAEK patients with Fuchs' dystrophy and no ocular comorbidities that would limit visual acuity, (retinal pathology, advanced glaucoma, epithelial irregularities, capsule opacities). Correlation analysis of preoperative graft thickness — measured by OCT — and BCVA at six months was performed. The thickness of the transplanted donor tissue was also considered as a proportion of the total thickness of the donor cornea, and this “percent thickness” was also analyzed for correlation with six-month BCVA. In addition, BCVA from grafts thicker than 130 microns were compared to BCVA from grafts thinner than 130 microns.
Overall graft thickness ranged between 80 to 200 microns. Mean BCVA at six months postop was 20/28 (Range: 20/16 to 20/60). There was no significant correlation between graft thickness and postop visual acuity in the thickness range between 100 and 200 microns. Grafts thicker than 130 um (n=314) yielded mean BCVA of 20/28, with 21% 20/20 or better. Grafts thinner than 130 um (n=42) yielded mean BCVA of 20/26 with 24% 20/20 or better. There was no significant difference in mean vision or in percent with 20/20 or better between groups.
The researchers concluded that “excellent vision can be obtained with grafts 200 microns and thinner and no correlation can be found between preoperative graft thickness and visual results.” They also noted that “special requests from eye banks for thin or ultra-thin tissue may not be justified.”
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■ Reminder signals boost medication compliance. In a small study involving eight glaucoma patients, German and French researchers placed electronic devices on Xal-Ease dosing aids capable of emitting visual and audible signals when patients did not adhere to their prescribed once-daily dosing regimen for Xalatan. For one month, the patients were left entirely on their own, with no signals activated. For the second month, the visual and audible signals were emitted when dosing did not occur at the appointed time. Without reminder signals, three out of eight patients had a drug coverage rate below 90% (mean 85.7 ±25.9 %), whereas with activated reminder signal, all patients had a coverage rate above 95% (mean 98.7 ±1.9 %). The researchers, who presented at ARVO 2012, concluded that “audible and visual reminder signals improved significantly adherence to topical latanoprost for glaucoma in this pilot study.” They suggested that larger, longer-term studies be conducted. ■ AMO's Mazzo to retire. Jim Mazzo, senior vice president, Abbott Medical Optics (AMO) and former chairman and CEO of AMO before it was acquired by Abbott, will retire from AMO at the end of the year. Mr. Mazzo will be replaced by Murthy Simhambhatla, PhD, who is currently the head of Abbott's Ibis Biosciences business. Before leading Ibis, Dr. Simhambhatla served as general manager of Abbott's vascular business in Australia and as divisional vice president and general manager of Abbott's drug-eluting stent business. ■ Phakic lOLs used after crosslinking. Researchers from NYU/MEETH in New York City sought to determine the effectiveness of implanting phakic IOLs (AcrySof Cachet) to correct significant residual anisometropia following treatment of keratoconus using photorefractive keratectomy with corneal cross-linking (Athens protocol). Twelve patients with more than 6 D of anisometropia and also with contact lens intolerance were implanted with the phakic lenses and followed for up to 1.5 years (mean follow-up was 0.9 years). The researchers, who presented their data at the recent ARVO meeting, found significant improvements in both uncorrected and spectacle-corrected visual acuity as well as a major decrease in mean refractive spherical equivalent. None of the eyes developed signs of ectasia progression. The researchers concluded that use of phakic IOLs in these types of cases is a safe and effective treatment in a highrisk group of patients. |
Causes of DSAEK Failures
Patient age may play a role.
■ Researchers at the Kellogg Eye Center at the University of Michigan sought to determine whether pre-cut donor corneal tissue characteristics have an effect on DSAEK dislocation rates. Their findings were presented at the recent ARVO meeting.
Pre- and postoperative data were obtained retrospectively on consecutive DSAEK procedures performed from 2007 to 2011 by six surgeons at one institution using eye bank pre-cut donor corneas. Data collected included: time of death to tissue processing (D-to-P), time of tissue processing to surgery (P-to-S), preoperative endothelial cell density (ECD), change in pre- versus postcut endothelial cell density and preoperative graft thickness. The primary outcome measure was graft dislocation.
The researchers reported that 355 patients underwent DSAEK; 57% were women and 43% men. Indications for surgery were Fuchs' dystrophy(81%), pseudophakic bullous keratopathy (16%) or other diagnoses (3%). There were 64 dislocation events(18%).
The mean D-to-P, mean P-to-S, mean preoperative ECD, mean change in pre- to post-cut ECD, and mean preoperative graft thickness were not significantly different between the two groups. The only variable that was statistically significantly different between the two groups was recipient age; mean age 70.2 in the no-dislocation group and 73.6 in the dislocation group. The patients' gender, preoperative diagnosis, and visually limiting ocular comorbidities were not associated with the occurrence of dislocation. Graft dislocation did not impact the patients' logMAR visual acuity at 1 year or at the last visit.
The researchers concluded that “pre-cut donor cornea tissue characteristics did not have a significant effect on dislocation rates after DSAEK. Older recipients were more likely to experience graft dislocation.” The likelihood of dislocation may be more affected by differences in recipient characteristics or surgical technique, rather than donor corneal tissue characteristics.
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■ Endothelial cell density and DSAEK graft survival. Researchers from Devers Eye Institute, presenting at ARVO, offered evidence that endothelial cell density (ECD) can play a role in the survival of DSAEK grafts. DSAEK was performed in 598 eyes with Fuchs' dystrophy. The eyes were then divided into two groups based on six-month ECD. Group 1 had an ECD <2000 (265 eyes) and Group 2 had an ECD >2000 (333 eyes) at the six month postoperative visit. Long-term survival rates were compared between the two groups. Follow-up time ranged from 184 to 2250 days. The researchers found that mean six-month ECD for group 1 was 1672 (36.8 % loss from pre-op), and 2306 for Group 2 (15.4% loss). There were a total of five graft failures, all within Group 1. Time to failure ranged from 184 to 1540 days. Graft survival rate was 98.1% for Group 1 and 100% for Group 2. |
Problems in Aniridic Eyes
Survey reveals multiple issues.
■ A survey conducted by ophthalmologists at the University of Virginia and presented at the recent ARVO meeting sought to determine the extent of corneal problems in aniridic eyes and how they were treated. Aniridia is a panocular disorder that can manifest with multiple problems, including glaucoma, foveal and optic nerve hypoplasia, visual disturbance and aniridia-associated keratopathy.
This study was a retrospective review of survey data collected in the Aniridia Foundation International registry. Subjects were asked about corneal pannus or scarring, age of onset, corneal surgical intervention, cataract and dry eyes. The cumulative proportion of subjects with corneal disease and cataract versus time was determined.
One hundred and three subjects responded to the survey. Of these, 43.7% had corneal pannus or scarring, while 45% did not and others were unsure. Of those with scarring, the average age at diagnosis was 20 years old, with a standard deviation of 12.2 years. Of the total of 103 individuals, 15.5% and 12.9% had keratolimbal allograft (KLAL) and penetrating keratoplasty (PK), respectively. Of those who received both PK and KLAL, 1.9% had PK prior to KLAL, and 6.8% reported PK after KLAL. Of the total subjects, 63.3% reported cataracts with an average age of 9.4 years at time of diagnosis. Dry eyes were reported in 56 of 102 (55%) subjects.
The researchers concluded that corneal disease is common in aniridia, with an average onset in young adulthood. Subjects with aniridia also had high prevalence of cataract and dry eyes.
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■ ReVision implant moves into phase 3. ReVision Optics, Inc., developer of an implantable inlay technology to treat presbyopia, has advanced its proprietary product PresbyLens into the final phase of its US clinical trial. PresbyLens is a clear, circular corneal inlay comprised of approximately 80% water and is less than half the thickness of a human hair. The phase 3 clinical trial will evaluate the safety and effectiveness of the PresbyLens in improving near vision in subjects with presbyopia. In this prospective, multicenter trial, subjects will be implanted with the PresbyLens in their non-dominant eye. “The PresbyLens is designed to reduce or even eliminate the need for reading glasses by microscopically changing the shape of the surface of one eye,” said Roger F. Steinert, MD, medical monitor for the PresbyLens clinical trial. “Subjects implanted with the PresbyLens in the phase 1 and 2 portions of this clinical trial measured average improvements on a standard eye chart of approximately five lines in near visual acuities and approximately one to two lines in intermediate visual acuities. The average loss in distance vision was about one line in the treated eye, while the subject's distance vision binocularly remained at 20/20. Subjects in the phase 1 trial have now been followed for more than two years and are demonstrating sustained visual acuity improvement and corneal health.” ■ New phaco simulator launched. A new, next-generation computer-based simulation tool, the Massachusetts Eye and Ear Cataract Master, is designed to bridge the learning gap that residents and ophthalmologists new to phaco must navigate prior to performing actual surgery. Nearly a decade in the making, the Cataract Master was co-developed by a team led by Bonnie An Henderson, MD, FACS, Harvard Medical School Ophthalmology Residency Training Program Director. The English version of the program is now available worldwide through the American Society of Cataract and Refractive Surgery Foundation. “The Cataract Master aims to minimize clinical risk while providing residents and practicing ophthalmologists with the most authentic cataract surgical experience possible outside the OR,” say the developers. “The goal is to boost skills and confidence, to better prepare residents for the surgical experience, and to raise the quality of patient care everywhere.” Computer-based simulation technology, primarily with the Eyesi technology, has been used in medical training since the early 2000s. Its developers say the Cataract Master is different in that it offers a self-guided, self-correcting curriculum that requires trainees to make decisions based on realistic surgical situations. The simulator, which can be accessed from any personal computer, contains realistic animations along with videos of actual surgeries - complete with expert discussions of each phase of the procedure. The interactive program includes frequent pop-up questions relating to the various surgical steps, with user answers then animated onscreen. If the user makes a serious error, videos provide immediate feedback explaining how the problem occurred, what to do to fix it, and how to avoid making the same mistake again. ■ Glaukos makes “most-promising” list. Glaukos Corp., whose iStent procedure for safe and blebless glaucoma surgery recently received FDA approval, has been selected as a Red Herring Top 100 North America Tech Startup, a prestigious award honoring the year's most promising private technology ventures. Glaukos is the only medical device company in North America to be selected for this honor. Red Herring's Top 100 Americas list is credited with identifying promising new companies and entrepreneurs. Red Herring editors were among the first to recognize that companies such as Facebook, Twitter, Google, Yahoo, Skype, Salesforce.com, YouTube, and eBay would change the way we live and work. ■ Preservative-free glaucoma medications favored. A survey of 117 ophthalmologists conducted by an advisory panel of glaucoma specialists in conjunction with Valeant Ophthalmics indicated that virtually all respondents (97%) felt that underlying ocular surface disease (OSD) in patients with glaucoma may be exacerbated by the use of preserved glaucoma medications, while 76% reported preservatives in glaucoma medications were a significant cause of the OSD they see in glaucoma patients. However, only 20% reported that the presence of preservatives in glaucoma medications had a high impact on their glaucoma prescribing decisions. Valeant produces the preservative-free glaucoma medication Timoptic. OM |
CORRECTION: In the ASCRS Preview Product Showcase that appeared in our March issue, Nidek's business relationship with Marco Ophthalmics and Santinelli International was incorrectly reported. It should have been stated that both Marco and Santinelli are distributors of Nidek products. Ophthalmology Management regrets the error. |