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Volume 12, Number 32
Monday, August 6, 2012
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AUGUST IS CATARACT AWARENESS MONTH




In this issue: (click heading to view article)
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######### Combination Cataract Surgery and Trabecular Micro-Bypass Stent Implantation in Patients with Mild-to-Moderate OAG and Cataract
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######### Link Between Glaucoma Risk Alleles at CDKN2B-AS1 and IOP, NTG, and Advanced Glaucoma
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######### Surgery Outcome Following Macula-Off Retinal Detachment
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######### Demographic and Geographic Changes in POAG in the United States
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Combination Cataract Surgery and Trabecular Micro-Bypass Stent Implantation in Patients with Mild-to-Moderate OAG and Cataract

The authors of this prospective, randomized, controlled multi-center clinical trial assessed the long-term safety and efficacy of a single trabecular micro-bypass stent with concomitant cataract surgery versus cataract surgery alone for mild-to-moderate open-angle glaucoma (OAG) at 29 U.S. investigational sites.

They randomly assigned eyes with mild-to-moderate glaucoma with an unmedicated intraocular pressure (IOP) of 22 mmHg or higher and 36 mmHg or lower to have cataract surgery with iStent trabecular micro-bypass stent implantation (stent group) or cataract surgery alone (control group). They followed patients for 24 months postoperatively.

The incidence of adverse events was low in both groups through 24 months of follow-up, the authors reported. They also noted that at 24 months, the proportion of patients with an IOP of 21 mmHg or lower without ocular hypotensive medications was significantly higher in the stent group than in the control group (p=.036). Overall, the mean IOP was stable between 12 months and 24 months (17.0 mmHg ± 2.8 [SD] and 17.1 ± 2.9 mmHg, respectively) in the stent group but increased (17.0 ± 3.1 mmHg to 17.8 ± 3.3 mmHg, respectively) in the control group. The study authors found that ocular hypotensive medication was statistically significantly lower in the stent group at 12 months; it was also lower at 24 months, although the difference was no longer statistically significant.

Patients with combined single trabecular micro-bypass stent and cataract surgery had significantly better IOP control on no medication through 24 months than patients having cataract surgery alone. Both groups had a similar favorable long-term safety profile.

SOURCE: Craven ER, Katz LJ, Wells JM, Giamporcara JE, iStent Study Group. Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-up. J Cataract Refract Surg. 2012;38(8):1339–1345.










Link Between Glaucoma Risk Alleles at CDKN2B-AS1 and IOP, NTG, and Advanced Glaucoma

Genetic variation at the 9p21 locus encompassing the CDKN2B-AS1, CDKN2A, and CDKN2B genes has been associated with primary open-angle glaucoma (POAG) in several independent studies. Researchers in Australia conducted the following comparative case series and case-control study to dissect the association further and to determine genotype–phenotype correlations between genetic variation at this locus and a range of glaucoma-related traits in a large cohort of POAG patients. Included in their study were 1,432 POAG patients and 595 unaffected controls recruited from two population-based and two cross-sectional studies.

The researchers genotyped each patient at nine single nucleotide polymorphisms (SNPs) previously associated with POAG at the 9p21 locus. They assessed each SNP for association with each outcome measure using linear regression under an additive genetic model. They explored associated traits further including adjustment for relevant covariates and they also analyzed highest recorded intraocular pressure (IOP) both with and without correction for central corneal thickness (CCT) and dichotomized these pressures into high-tension glaucoma and normal-tension glaucoma (NTG). IOP and vertical cup-to-disc ratio (VCDR) were the main outcome measures.

According to the study researchers, glaucoma risk alleles at 9p21, particularly rs7049105 and rs10120688, were associated with the presence of both NTG and advanced POAG. They also noted that the SNP rs10120688 was associated with greater VCDR after adjustment for covariates (p=0.003;β=0.016; standard error, 0.006). They reported that multiple SNPs in the region were associated with reduced IOP, before and after adjustment for CCT and that the SNP most significantly associated with IOP was also rs10120688 (p=0.001; β=–2.135; standard error, 0.634) after adjustment for covariates under an additive model. In a comparison of high-tension versus low-tension glaucoma, the researchers found that this SNP was also the most significantly associated, particularly when IOP was corrected for CCT before classification of the type of glaucoma (p=0.0009; odds ratio, 0.63; 95% confidence interval, 0.48–0.83).

In conclusion, patients with POAG carrying the glaucoma risk alleles at the 9p21 locus have larger VCDR and lower IOP than POAG patients without these alleles. Carriers of these alleles seem to be predisposed to PAOG developing at lower IOP levels and exhibit stronger associations with NTG and advanced glaucoma phenotypes. This may be of relevance when setting target pressures in patients carrying these risk alleles.

SOURCE: Burdon KP, Crawford A, Casson, et al. Glaucoma risk alleles at CDKN2B-AS1 are associated with lower intraocular pressure, normal-tension glaucoma, and advanced glaucoma. Ophthalmology. 2012;119(8):1539–1545.



http://www.revophth.com/avtt2012






Surgery Outcome Following Macula-Off Retinal Detachment

To evaluate the anatomical success rate of scleral buckling surgery in the treatment of rhegmatogenous retinal detachment and to evaluate the differences in outcome between patients suffering macula-off retinal detachment and those without a macular involvement, the Munster Study on Therapy Achievements in Retinal Detachment (MUSTARD) retrospective interventional case series was conducted.

A total of 4,325 patients who underwent surgery between 1980 and 2001 were included. The macular was involved in 53.94% (n=2,134) of 3,956 patients with nontraumatic retinal detachment. The main outcome measure was the achievement of dry anatomical attachment of the retina.

The success rate in patients with macula-off retinal detachment is 80.46% and thus 7.78% lower (p<0.01) than that in those patients with their macula intact whose success rate amounted to 88.24%. The overall success rate of all 4,325 MUSTARD patients was 83.98%.

It was concluded that scleral buckling is an established and mostly successful method for the treatment of retinal detachment. As this case series demonstrated, even eyes with macula-off can be treated successfully by this procedure, thereby avoiding the complications of primary vitrectomy.

SOURCE: Thelen U, Amler S, Osada N, Gerding H. Outcome of surgery after macula-off retinal detachment — results from MUSTARD, one of the largest databases on buckling surgery in Europe. Acta Ophthalmol. 2012;90(5):481–486.

 



http://www.revophth.com/saos2012






Demographic and Geographic Changes in POAG in the United States

To examine how demographic and geographic variations in U.S. populations from 2011 to 2050 will contribute to estimated numbers of primary open-angle glaucoma (POAG) cases, investigators performed this cross-sectional study.

They used prevalence rates from selected population-based studies to estimate the number of persons aged 40 years and older with POAG in the United States. For calculation, they multiplied the age-, sex-, and race/ethnicity-specific prevalence rates by the U.S. Census estimates and projections from 2011 to 2050. Main outcome measures are estimated numbers of persons with POAG in different age, sex, and racial/ethnic groups and total and per capita POAG rates by state.

The investigators reported that in 2011, 2.71 millions persons in the United States had POAG, with the highest estimated number among populations aged 70 to 79 years (31%), women (53%), and non-Hispanic whites (44%). They noted that the largest demographic group is non-Hispanic white women. In 2050, an estimated 7.32 million persons will have POAG, with the highest number among populations aged 70 to 79 years (32%), women (50%), and Hispanics (50%). The largest demographic group will shift to Hispanic men, the investigators predict. During the next 40 years, the highest per capita POAG rates will double to New Mexico, Texas, and Florida.

Despite the high prevalence of POAG in African Americans and Hispanics, the largest group in the United States is currently among older non-Hispanic white women, but is expected to shift to Hispanic men over the next few decades. Given this shift, the greatest yield from screening programs is likely to be in those states with high numbers of non-Hispanic white women and Hispanic men.

SOURCE: Vajaranant TS, Wu S, Torres M, Varma R. The changing face of primary open-angle glaucoma in the United States: demographic and geographic changes from 2011 to 2050. Am J Ophthalmol. 2012;154(2):303–314.




http://www.revophth.com/ResFellowEdu2012







  • INSITE VISION INITIATES FIRST PHASE 3 CLINICAL STUDY OF BROMSITE IN CATARACT SURGERY. InSite Vision Incorporated has announced that patient enrollment has begun in the first Phase 3 clinical trial of BromSite (ISV-303) for the reduction of pain and inflammation after cataract surgery. According to the company, the study will seek to enroll approximately 240 patients undergoing cataract surgery in a two-arm trial designed to evaluate the efficacy and safety of BromSite against the DuraSite vehicle alone. BromSite combines a low dose (0.075%) of the non-steroidal anti-inflammatory drug (NSAID) bromfenac with InSite Vision's DuraSite drug delivery technology. This is the first of two Phase 3 clinical studies in support of BromSite's regulatory submissions. Using 15 separate sites, patients undergoing cataract surgery will be randomized and then dosed b.i.d. beginning the day before surgery and continuing the day of surgery and 14 days post-surgery. Click here to learn more.
  • FIRST DRY AMD PATIENT TREATED WITH HIGHER DOSAGE OF EMBRYONIC STEM CELL-DERIVED RPE CELLS. Advanced Cell Technology, Inc. has announced treatment of the fourth patient, the first in the second patient cohort, in its Phase 1/2 clinical trial for dry age-related macular degeneration (AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). On August 1st, the patient was injected with 100,000 hESC-derived RPE cells at Wills Eye Institute in Philadelphia and is recovering uneventfully. The dry AMD trial is one of three clinical trials being carried out by the company in the United States and in Europe. To learn more, visit www.advancedcell.com.
  • KISNER APPOINTED TO LPATH BOARD OF DIRECTORS. Lpath, Inc. has appointed Daniel L. Kisner, M.D., to its board of directors. Most recently, Dr. Kisner served as a partner at Aberdare Ventures and prior to that, he was president and CEO of Caliper Technologies.






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