#########
Volume 12, Number 34
Monday, August 20, 2012
#########


AUGUST IS CATARACT AWARENESS MONTH




In this issue: (click heading to view article)
#########
######### Link Between Cataract and Cataract Extraction and AMD
#########
######### Use of Enzymatic Vitreolysis with Ocriplasmin for Treatment of Vitreomacular Traction and Macular Holes
#########
######### Effect of Homocysteine on Oxidative Stress in Young Adult CRVO
#########
######### Safety, Tolerability, and Reproducibility of Continuous 24-Hour IOP Pattern Monitoring in Glaucoma Patients
#########
######### Briefly

 

 





Link Between Cataract and Cataract Extraction and AMD

Beaver Dam Eye Study participants aged 43 to 86 years were involved in the baseline examination in 1988–1990 of the following longitudinal population-based study of age-related eye diseases to examine the associations of cataract and cataract surgery with early and late age-related macular degeneration (AMD) over a 20-year interval.

Participants were followed up at five-year intervals after the baseline examination. Examinations consisted of ocular examination with lens and fundus photography, medical history, measurements of blood pressure, height, and weight. Values of risk variables were updated, and incidences of early and late AMD were calculated for each five-year interval. Additionally, odds ratios were computed using discrete linear logistic regression modeling with generalized estimating equation methods to account for correlation between the eyes and multiple intervals. AMD was the main outcome measure.

After adjusting for age and sex, neither cataract nor cataract surgery was associated with increased odds for developing early AMD. Further adjusting for high-risk gene alleles (CFH and ARMS2) and other possible risk factors did not materially affect the odds ratio (OR). However, cataract surgery was associated with incidence of late AMD (OR 1.93; 95% confidence interval [CI], 1.28–2.90). This OR was not materially altered by further adjusting for high-risk alleles (CFH Y402H, ARMS2) or other risk factors. It was noted that the OR for late AMD was higher for cataract surgery performed five or more years prior compared with less than five years prior.

These data strongly support the past findings of an association of cataract surgery with late AMD independent of other risk factors, including high-risk genetic status, and suggest the importance of considering these findings when counseling patients regarding cataract surgery. These findings should provide further impetus for the search for measures to prevent or delay the development of age-related cataract.

SOURCE: Klein BE, Howard KP, Lee KE, et al. The relationship of cataract and cataract extraction to age-related macular degeneration: the Beaver Dam Eye Study. Ophthalmology. 2012;119(8):1628–1633.










Use of Enzymatic Vitreolysis with Ocriplasmin for Treatment of Vitreomacular Traction and Macular Holes

Vitreomacular adhesion (VMA) can lead to pathologic traction and macular hole. The standard treatment for severe, symptomatic VMA is vitrectomy. Ocriplasmin is a recombinant protease with activity against fibronectin and laminin, components of the vitreoretinal interface.

Researchers conducted two multicenter, randomized, double-blind, Phase III clinical trials to compare a single intravitreal injection of ocriplasmin (125 µg) with a placebo injection in patients with symptomatic VMA. The primary end point was resolution of VMA at day 28. Secondary end points were total posterior vitreous detachment and nonsurgical closure of a macular hole at 28 days, avoidance of vitrectomy, and change in best-corrected visual acuity (BCVA).

Overall, the researchers treated 652 eyes: 464 with ocriplasmin and 188 with placebo. They reported that VMA resolved in 26.5% of ocriplasmin-injected eyes and in 10.1% of placebo-injected eyes (p<0.001). They also found that total posterior vitreous detachment was more prevalent among the eyes treated with ocriplasmin than among those injected with placebo (13.4% vs. 3.7%, p<0.001). The study researchers achieved nonsurgical closure of macular holes in 40.6% of ocriplasmin-injected eyes, as compared with 10.6% of placebo-injected eyes (p<0.001). They noted that the BCVA was more likely to improve by a gain of at least three lines on the eye chart with ocriplasmin than with placebo. Furthermore, ocular adverse events (e.g., vitreous floaters, photopsia, or injection-related eye pain—all self-reported—or conjunctival hemorrhage) occurred in 68.4% of ocriplasmin-injected eyes and in 53.5% of placebo-injected eyes (p<0.001), and the incidence of serious ocular adverse events was similar in the two groups (p=0.26).

In conclusion, intravitreal injection of the vitreolytic agent ocriplasmin resolved vitreomacular traction and closed macular holes in significantly more patients than did injection of placebo and was associated with a higher incidence of ocular adverse events, which were mainly transient.

SOURCE: Stalmans P, Benz MS, Gandorfer A, et al; for the MIVI-TRUST Study Group. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Eng J Med. 2012;Aug 16. [Epub ahead of print].



http://www.revophth.com/saos2012






Effect of Homocysteine on Oxidative Stress in Young Adult CRVO

High levels of plasma homocysteine have been reported to be toxic to the vascular endothelium, thereby creating an environment of hypercoagulability and occlusion. Elevated homocysteine has been reported as a risk factor for young adult central retinal vein occlusion (CRVO) cases. In India, investigators aimed to determine whether oxidative stress is an independent risk factor or is homocysteine-dependent.

They included 23 young adult CRVO patients and 54 age and sex-matched controls in the study and estimated oxidative stress markers thiobarbituric acid-reacting substance (TBARS), superoxide dismutase (SOD), total thiols, glutathione peroxidase, and total antioxidant capacity (TAC). Finally, they measured the effect of homocysteine (25 µm to 200 µm) on cultured bovine retinal endothelial cells (BREC) on oxidative stress parameter TBARS.

According to the investigators, there was a significant increase in the plasma TBARS in CRVO cases compared with controls (p=0.000). They found that SOD and TAC were significantly lower in CRVO cases than controls (p=0.000, p=0.022) and that there was a significant negative correlation between TAC and TBARS (p=0.00) and a significant positive correlation between homocysteine and TBARS (p=0.029). Nominal regression analysis showed that TAC and homocysteine influence TBARS significantly. The in vitro study in BREC cells revealed that homocysteine increased the TBARS dose and time dependently.

TBARS and homocysteine are known to be independent risk factors for CRVO. TBARS can be influenced by both homocysteine and TAC, thereby contributing to the aetiopathology of CRVO by increasing oxidative stress, the investigators determined.

SOURCE: Devi SR, Suganewsari G, Sharma T, et al. Homocysteine induces oxidative stress in young adult central retinal vein occlusion. Br J Ophthalmol. 2012;96(8):1122–1126.

 



http://www.revophth.com/ResFellowEdu2012






Safety, Tolerability, and Reproducibility of Continuous 24-Hour IOP Pattern Monitoring in Glaucoma Patients

To examine the safety, tolerability, and reproducibility of intraocular pressure (IOP) patterns during repeated continuous 24-hour IOP monitoring with a contact lens sensor, the authors of this study investigated 40 patients suspected of having glaucoma (n=21) or with established glaucoma (n=19).

Patients participated in two 24-hour IOP monitoring sessions (S1 and S2) at a one-week interval. Patients pursued daily activities, and sleep behavior was not controlled. The authors assessed reproducibility of signal patterns using Pearson correlations as well as the incidence of adverse events and tolerability (visual analog scale score).

They reported that the mean (SD) age of the patients was 55.5 (15.7) years, and 60% were male. Main adverse events were blurred vision (82%), conjunctival hyperemia (80%), and superficial punctate keratitis (15%). The mean (SD) visual analog scale score was 27.2 (18.5) mm in S1 and 23.8 (18.7) mm in S2 (p=.22). Overall correlation between the 2 sessions was 0.59 (0.51 for no glaucoma medication and 0.63 for glaucoma medication) (p=.12). Moreover, the study authors detected mean (SD) positive linear slopes of the sensor signal from wake to two hours into sleep in both sessions for the no glaucoma medication group (S1: 0.40 [0.34], p<.001; S2: 0.33 [0.30], p<.01) but not for the glaucoma medication group (S1: 0.24 [0.60], p=.06; S2: 0.40 [0.40], p<.001).

To conclude, repeated use of the contact lens sensor demonstrated good safety and tolerability. The recorded IOP patterns showed fair to good reproducibility, suggesting that data from continuous 24-hour IOP monitoring may be useful in the management of patients with glaucoma.

SOURCE: Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. Continuous 24-hour monitoring of intraocular pressure patterns with a contact lens sensor: safety, tolerability, and reproducibility in patients with glaucoma. Arch Ophthalmol. 2012; Aug 13. [Epub ahead of print].

 







  • WEILL CORNELL MEDICAL COLLEGE RESEARCHERS MAKE BLIND MOUSE RETINAS SEE. Two researchers at Weill Cornell Medical College have deciphered a mouse's retina's neural code and coupled this information to a novel prosthetic device to restore sight to blind mice. Furthermore, the researchers say they've also cracked the code for a monkey brain, which is essentially identical to that of a human. They hope to quickly design and test a device that blind humans can use. While current prosthetics provide blind users with spots and edges of light to help them navigate, this novel device provides the code to restore normal vision. The code is so accurate that it can allow facial features to be discerned and allow animals to track moving images. The researchers' work was reported in the Proceedings of the National Academy of Sciences. According to lead researcher Dr. Sheila Nirenberg, “Not only is it necessary to stimulate large numbers of cells, but they also have to be stimulated with the right code–the code the retina normally uses to communicate with the brain.” She says that the findings of the recent research show that the critical ingredients for building a highly effective retinal prosthetic—the retina's code and a high resolution stimulating method—are now, to a large extent, in place and that her retinal prosthetic will need to undergo human clinical trials, especially to test safety of the gene therapy component, which delivers the light–sensitive protein. Click here to read more.
  • LUCENTIS APPROVED FOR TREATMENT OF DME. Genentech recently announced that Lucentis (ranibizumab injection) 0.3 mg once monthly was approved by the FDA for the treatment of diabetic macular edema (DME) and physicians can now place orders for the drug. Lucentis 0.5 mg once monthly was first approved by the FDA to treat wet age-related macular degeneration (AMD) in 2006 and for macular edema following retinal vein occlusion in 2010. The approval of Lucentis in DME was based on Genentech's Phase III trials, RIDE and RISE, two identically designed, parallel, double-masked, three-year clinical trials, which were sham-treatment controlled for 24 months. Lucentis demonstrated improved clinical outcomes including substantial visual gain for many DME patients.
  • CLINICAL TRIAL RESULTS AVAILABLE FOR SHAPE OPHTHALMICS' PUNCTAL PLUG. Shape Ophthalmics LLC recently reported that interim result analysis for the Shape Ophthalmics proprietary shape memory polymer punctal plug for dry eye treatment and potential platform for drug delivery has shown 93.6% (44/47 plugs) retention at 30 days. The study was a prospective, single-arm clinical trial with plug retention designated as the primary endpoint, and 21 patients received superior and/or inferior plugs at enrollment. They were followed at one day, one week and one month, and follow-up visits are planned over the next two months. The Shape Ophthalmics plug was inserted in both superior and inferior puncta using a single plug model for all implantations. Data collected included retention over time as well as adverse events such as infection, discomfort, and tearing. The company notes that no significant adverse events have been reported to date. It is initiating the 510(k) FDA approval process and is seeking a strategic partner to bring the technology to market.






Review of Ophthalmology® Online is published by the Professional Publications Division of Jobson Medical Information LLC (JMI), 11 Campus Boulevard, Newtown Square, PA 19073.

To subscribe to other JMI newsletters or to manage your subscription, click here.

To change your email address, reply to this email. Write "change of address" in the subject line. Make sure to provide us with your old and new address.

To ensure delivery, please be sure to add reviewophth@jobsonmail.com to your address book or safe senders list.

Click here if you do not want to receive future emails from Review of Ophthalmology Online.

Advertising: For information on advertising in this e-mail newsletter or other creative advertising opportunities with Review of Ophthalmology, please contact publisher Rick Bay, or sales managers James Henne or Michele Barrett.

News: To submit news or contact the editor, send an e-mail, or FAX your news to 610.492.1049