Volume 14, Number 26
Monday, June 30, 2014

In this issue: (click heading to view article)
######### IOP-Lowering Effect of Phacoemulsification Alone and Combined with Canaloplasty in Glaucoma Patients
######### Predicting One-Month Response of Macular Edema to Intravitreal Bevacizumab Based on One-Hour Response
######### Vitrectomy and Subretinal Injection of Tissue Plasminogen Activator for Large Submacular Hemorrhage Secondary to AMD
######### Link Between Dietary Carbohydrate Intake and Dietary Glycemic Index and Risk of Age-Related Cataract
######### Briefly

IOP-Lowering Effect of Phacoemulsification Alone and Combined with Canaloplasty in Glaucoma Patients

To evaluate efficacy and survival rates of intraocular pressure-lowering effect obtained with phacoemulsification alone or in combination with canaloplasty (PCP) in patients with open-angle glaucoma, this retrospective chart review of consecutive cases at the Department of Ophthalmology, Indiana University, analyzed visual acuity, IOP, number of medications, failures and survival rates of IOP-lowering effect.

Inclusion criteria were: patients older than 18 years with OAG and cataract. Exclusion criteria were: no light perception vision; prior glaucoma surgery; chronic uveitis; angle-closure glaucoma; and advanced- or end-stage OAG. Failure criteria were: IOP >21 mmHg or <20% reduction; IOP <6 mmHg; further glaucoma surgeries; and loss of light perception vision.

A total of 37 patients underwent phaco and 32 had PCP. Follow-up was 21.8 ± 10.1 vs. 18.8 ± 9.6 months for phaco and PCP, respectively (p=0.21). Age (y) (74.7 ± 9.8 vs. 76.1 ± 8.3, p=0.54), sex (p=81) and laser status (p=0.75) were similar between the groups. Preoperatively, mean ±SD logMAR VA (0.5 ± 0.7 vs. 0.5 ± 0.5, p=0.77), IOP (16.2 ± 4.6 vs. 18.2 ± 5.1, p=0.13) and meds (1.4 ± 1.1 vs. 1.3 ± 0.7, p=0.75) were similar for phaco and PCP, respectively. At 24-month phaco (n=17) and PCP (n=11), respectively, mean ±SD were: logMAR VA 0.2 ± 0.2 vs. 0.4 ± 0.7, p=0.29; IOP 14.1 ± 4.0 vs. 12.9 ± 3.8, p=0.43; and meds 1.5 ± 1.2 vs. 0.3 ± 0.5, p=0.005. Rates of successful IOP lowering without medications for phaco versus PCP at 12 months were 34% vs. 75%, respectively (p=0.003).

In conclusion, a combination of canaloplasty with phaco results in a decreased number of glaucoma medications and increased survival rate of IOP-lowering effect compared with phaco alone.

SOURCE: Arthur SN, Cantor LB, WuDunn D, et al. Efficacy, safety, and survival rates of IOP-lowering effect of phacoemulsification alone or combined with canaloplasty in glaucoma patients. J Glaucoma. 2014;23(5):316–320.

Predicting One-Month Response of Macular Edema to Intravitreal Bevacizumab Based on One-Hour Response

Korean researchers performed the following retrospective case series to evaluate the clinical significance of the change in central macular thickness measured one hour after intravitreal bevacizumab injection for macular edema secondary to diabetic retinopathy or retinal vein occlusion.

Participants consisted of 30 eyes with ME treated with intravitreal bevacizumab. The researchers administered a single intravitreal bevacizumab injection (1.25 mg/0.5 mL) in 14 eyes with diabetic macular edema and 16 eyes with ME secondary to RVO. They measured CMT using spectral-domain optical coherence tomography before injection and again one hour and one month after injection.

The study researchers observed statistically significant CMT reduction at both time points, and they noted that CMT declined from 542.3 ± 127.7 µm at baseline to 516.9 ± 123.4 µm one hour after injection (p<0.001) and to 345.5 ± 110.0 µm at one month after injection (p<0.001). They noted that the reduction in CMT one hour after injection was significantly correlated with the reduction in CMT observed at one month after injection, with respect to both absolute (r=0.515, p=0.004) and relative changes (r=0.454, p=0.012). The 15 eyes that had larger one-hour CMT reductions also showed larger one-month CMT reductions (242.9 ± 133.8 µm and 43.4% ± 16.5%) when compared with 15 eyes with smaller one-hour CMT reductions (148 ± 130.6 µm and 25.0% ± 18.3%). This trend was the same for absolute and relative changes (p=0.037 and 0.008), the researchers reported..

They determined that the one-month response of ME to intravitreal bevacizumab injection can be predicted by checking CMT one hour after injection.

SOURCE: Ma DJ, Park KH, Woo SJ. Predicting 1-month response of macular edema to intravitreal bevacizumab from 1-hour response. Can J Ophthalmol. 2014;49(3):267–272.


Vitrectomy and Subretinal Injection of Tissue Plasminogen Activator for Large Submacular Hemorrhage Secondary to AMD

The authors of this retrospective study evaluated the efficacy and safety of pars plana vitrectomy with subretinal injection of tissue plasminogen activator for the treatment of large submacular hemorrhage secondary to age-related macular degeneration and identify parameters correlated with the visual prognosis.

They included 31 eyes that underwent PPV with subretinal tPA injection for large SMH secondary to AMD. Main outcome measure was improvement in at least one line in visual acuity.

Improvement in VA was achieved in 14 (45.2%) patients, the authors reported. They also found that these patients had a significantly worse VA at presentation than patients who did not improve (p=0.05). Additionally, central retinal thickness and earlier intervention were not correlated with the final visual prognosis. Postoperative complications included retinal detachment (19.3%), recurrent SMH (6.4%) and elevated intraocular pressure (6.4%).

To conclude, the VA at presentation is the most significant preoperative parameter associated with improvement in VA. A cutoff value of counting fingers VA is suggested, as patients with better VA at presentation did not benefit from surgery.

SOURCE: Moisseiev E, Ami TB, Barak A. Vitrectomy and subretinal injection of tissue plasminogen activator for large submacular hemorrhage secondary to AMD. Eur J Ophthalmol. 2014; June 12. [Epub ahead of print].


Link Between Dietary Carbohydrate Intake and Dietary Glycemic Index and Risk of Age-Related Cataract

Investigators in China aimed to determine the association of dietary carbohydrate intake and dietary glycemic index, and risk of age-related cataract and quantitatively estimate their dose-response relationships.

They searched Medline, the Cochrane Library, Excerpta Medica database (EMBASE), Institute for Scientific Information Science Citation Index, ISI Web of Knowledge and China National Knowledge Infrastructure databases before October 2013. Two authors independently extracted data and assessed study quality, and the investigators used the random-effect model to calculate the pooled odds ratios. They also carried out dose-response analyses, subgroup analyses based on ARC subtypes, heterogeneity and publication bias assessment.

Seven studies were included in this meta-analysis. The pooled ORs of ARC for the highest versus the lowest category of carbohydrate intake and GI were 1.18 (95% confidence interval [CI]: 1.01 to 1.38) and 1.15 (95% CI: 1.00 to 1.32), respectively, the investigators noted. Further subgroup analyses based on ARC subtypes suggested a marginally significant association between higher carbohydrate intake and cortical cataract risk (OR: 1.37, 95% CI: 0.99 to 1.90), and a statistically significant association between higher GI and nuclear cataract risk (OR: 1.23, 95% CI: 1.03 to 1.46). In addition, a significant dose-response relationship was observed between carbohydrate intake and the risk of cortical cataract.

These results indicate that higher dietary carbohydrate quantity and GI may be associated with the risk of cortical and nuclear cataract, respectively. The results should be interpreted cautiously and more studies are warranted to clarify this issue.

SOURCE: Wu H, Zhang H, Li P, et al. Association between dietary carbohydrate intake and dietary glycemic index and risk of age-related cataract: a meta-analysis. Invest Ophthalmol Vis Sci. 2014;55(6):3660–3668.


  • RESEARCHERS CREATE MINI LIGHT-SENSING RETINA. Researchers at Johns Hopkins recently reported that they have created a 3-D complement of human retinal tissue in the laboratory, which includes functioning photoreceptor cells capable of responding to light. The achievement emerged from experiments with human-induced pluripotent stem cells and could eventually enable genetically engineered retinal cell transplants that halt or even reverse a patient's march toward blindness, the researchers say. Read the online article in the journal Nature Communications.   

  • POSITIVE INTERIM TOP-LINE CLINICAL RESULTS ANNOUNCED FROM PHASE II STUDY OF SQUALAMINE EYE DROPS FOR WET AMD. Ohr Pharmaceuticals recently announced positive top-line interim results for its randomized, double-masked, placebo-controlled Phase II clinical trial (Study OHR-002) of squalamine eye drops used in combination with Lucentis p.r.n. for the treatment of wet age-related macular degeneration. The data demonstrated a positive benefit in visual function across multiple clinically relevant endpoints, including a mean change in visual acuity at the end of study visit for the interim analysis group of +10.4 letters with squalamine eye drops plus Lucentis p.r.n. versus +6.3 letters in the placebo eye drops plus Lucentis p.r.n. arm, a 65% additional relative benefit (p=0.18). The squalamine-treated group demonstrated improved best-corrected visual acuity gains relative to the placebo group at all time points evaluated from four to 38 weeks. Ohr plans to present the full data from this interim analysis in the second half of this year, with final clinical trial data expected in the first quarter of 2015.

  • RESULTS OF PHASE IIb STUDY OF ROCLATAN REPORTED. Aerie Pharmaceuticals Inc. shared results of its Phase IIb trial for once-daily, quadruple-action Roclatan. The drug is a combination of the company's triple-action Rhopressa with the prostaglandin analogue latanoprost and the 28-day clinical trial included 297 patients. Roclatan achieved its primary efficacy endpoint of statistically significant superiority over each of its components on day 29. The baseline intraocular pressures tested in the study ranged from 22 mmHg to 36 mmHg. Roclatan lowered mean diurnal IOP on day 29 from 25.1 mmHg at baseline to 16.5 mmHg. Roclatan mean diurnal IOP reduction on day 29 was approximately 2 mmHg greater than latanoprost. Additionally, Roclatan efficacy exceeded that of latanoprost by 1.6 mmHg to 3.2 mmHg across each time point evaluated during the study (8 a.m., 10 a.m., 4 p.m. on days eight, 15 and 29). These results were statistically significant at all time points with p values <0.05. For more highlights of the study results, click here.

  • BAUSCH + LOMB LAUNCHES NEW EYE DROP, RECEIVES FDA CLEARANCE FOR DAILY DISPOSABLE MULTIFOCAL CONTACT LENS. Bausch + Lomb has announced the availability of Soothe Xtra Protection (XP) eye drops with Restoryl, a unique emulsion system featuring a proprietary blend of mineral oils and interfacial molecules. The company says the drops target the main source of dry-eye symptoms by replenishing the lipid layer of the tear film. The product is preserved with polyquaternium-1 (PQ1) and has a borate buffer system. Soothe XP is now available at Walmart and will be available in Target in July. Additional retailers will follow in the coming months.

    Bausch + Lomb also recently reported that the FDA has issued marketing clearance for Biotrue ONEday for Presbyopia (nesofilcon A) soft contact lens, the first daily disposable multifocal contact lens from the Biotrue ONEday family of products. Featuring a next-generation 3-Zone Progressive design, along with bio-inspired HyperGel material, the new lens provides comfortable vision throughout the day, and offers near, intermediate and distance vision. Read more Bausch + Lomb news here.

  • AIR OPTIX COLORS NOW AVAILABLE. Alcon unveiled Air Optix Colors prescription contact lenses, a new color contact lens that encapsulates the company's 3-in-1 Color Technology in a silicone hydrogel lens. Available in nine colors, Air Optix Colors contact lenses are the first monthly replacement, daily wear color lenses available in the United States on a silicone hydrogel platform, allowing up to six times more oxygen through the contact lens compared to the leading, older technology color contact lens. The lenses are available in prescription and plano form to consumers through their eye-care professional. According to Alcon, there is no refit required for current Air Optix Aqua contact lens wearers. Find out more here.

  • JOHNSON & JOHNSON OFFERS SIX-MONTH SUPPLY OF ACUVUE OASYS BRAND CLS, DISCONTINUES ACUVUE ADVANCE BRAND IN THE U.S. Johnson & Johnson Vision Care Inc.'s Acuvue Oasys Brand Contact Lenses are now available in a new six-month Supply Pack (12 lenses per box), which will replace all three-month Supply Packs (six lenses per box). The Acuvue Oasys six-month Supply Pack will be available in all parameters that are currently available in the current three-month and Annual Supply packs: power ranges of 8.4 and 8.8 BC including –0.50D to –6.00 in 0.25D steps, –6.50D to –12.00D in 0.50 steps, +0.50D to +6.00D in 0.25D steps, and +6.50D to +8.00D in 0.50D steps.

    In other company news, Acuvue Advance Brand Contact Lenses, Acuvue Advance Brand for Astigmatism and Acuvue Advance Plus Brand will be discontinued effective March 31, 2015, and revenue lenses will no longer be available for sale from the company. Diagnostic lenses for Acuvue Advance Plus will be discontinued effective August 1, 2014. Additionally, all remaining parameters of Acuvue Brand Contact Lenses will also be discontinued on March 31, 2015. Johnson & Johnson Vision care will provide in-office tools to help doctors and staff transition patients from Acuvue Advance Brand Family and Acuvue Brand to the most current Acuvue technology. To ease the transition, the company is offering a Fitting Fee Reimbursement of up to $100 toward patients' fitting fees when Acuvue Advance Brand Family or Acuvue Brand wearers are prescribed an annual supply of any product in the Acuvue Oasys Brand Family, 1-Day Acuvue Moist Brand Family or 1-Day Acuvue TruEye Brand Contact Lenses. Stop by Johnson & Johnson's website for more details.

  • 300TH PATIENT ENROLLED IN CLINICAL STUDY OF LIGHT ADJUSTABLE LENS. Calhoun Vision has enrolled the 300th patient in the Phase III clinical study of its Light Adjustable Lens. The study, which is being conducted at 18 centers across the country, will include 600 patients, with 400 implanted with the LAL and 200 implanted with a monofocal control lens of the surgeon's choosing. According to Calhoun, its LAL technology is designed to allow surgeons to change and customize the power of the lens after it has been implanted in the eye. Patients return for one or two follow-up visits, during which the surgeon evaluates his vision and performs an adjustment to customize the shape and power of the lens by exposing it to ultraviolet light. Once the desired visual target is achieved, the surgeon locks in the lens with a final light treatment. Get more information at www.calhounvision.com.

  • ECR PHARMACEUTICALS SOLD TO VALEANT PHARMACEUTICALS. In recent headlines, Akorn Inc. divested its subsidiary, ECR Pharmaceuticals, to Valeant Pharmaceuticals for $41 million in cash and assumption of certain liabilities. Click here to read more.

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