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Volume 16, Number 45
Monday, November 7, 2016
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NOVEMBER IS DIABETIC EYE DISEASE AWARENESS MONTH



In this issue: (click heading to view article)
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######### Identification of SD-OCT Parameters in Eyes With Early HTG and LTG
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######### Intravitreal Ranibizumab & Oral DHA Supplementation Plus Antioxidants for DME
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######### Modified Canaloplasty: New Option for Glaucoma Cases With Disrupted Schlemm’s Canal Wall
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######### Incidence & Growth of GA: Five Years of AMD Treatment Trials
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  Briefly

 



Identification of SD-OCT Parameters in Eyes With Early HTG and LTG

Researchers compared the diagnostic ability of macular ganglion cell complex and peripapillary retinal nerve fiber layer thickness in high-tension glaucoma and low-tension glaucoma.

Glaucoma was defined as glaucomatous optic neuropathy and reproducible visual field defects. Subjects were classified as having LTG if untreated intraocular pressure was ≤21 mmHg on two different occasions. Only eyes with early glaucoma (mean deviation <−6 dB) were included. All individuals underwent spectral-domain optical coherence tomography imaging.

A total of 56 normal subjects—64 with HTG and 35 with LTG—were enrolled. Overall, after adjusting for mean deviation and age, the average pRNFL thickness in eyes with LTG was 18.7 µm thinner than in eyes with HTG (17 percent difference, p<0.01). In the HTG group, researchers found no significant difference between areas under the receiver operating characteristic curve for average GCC and average pRNFL thicknesses (0.77 vs. 0.68, p=0.06). In the LTG group, average pRNFL thickness had a significantly larger AUC compared with average GCC thickness (0.95 vs. 0.81, p<0.001). Although the average GCC had similar AUCs in the HTG and LTG groups (p=0.47), the average pRNFL thickness had a significantly larger AUC in the LTG group (p<0.001).

Researchers concluded that in eyes with early glaucoma, a pRNFL thickness scan seemed to be a more accurate SD-OCT protocol to identify those with LTG compared with the GCC thickness scan.

SOURCE: Gracitelli CPB, Moreno PA, Leite M, et al. Identification of the most accurate spectral-domain optical coherence tomography parameters in eyes with early high-tension and low-tension glaucoma. J Glaucoma 2016;25:10:854-9.





Intravitreal Ranibizumab & Oral DHA Supplementation Plus Antioxidants for DME

Investigators assessed the two-year effectiveness of intravitreal ranibizumab combined with a dietary supplement rich in docosahexaenoic acid along with antioxidants in 62 individuals with diabetic macular edema. Brudy Technology (Barcelona), a maker of DHA nutritional products, was a collaborator on the study.

In a randomized, single-blind, controlled study, 33 subjects (42 eyes) received intravitreal ranibizumab alone and 29 (34 eyes) combined with DHA (1,050 mg/day). Monthly ranibizumab (0.5 mg) for the first four months was followed by as-needed treatment.

At 24 months, the difference in the reduction of central subfield macular thickness between groups significantly favored the DHA supplementation group (CI, 7.20 to 97.656; p=0.024), although improvement in best-corrected visual acuity measured in the Early Treatment Diabetic Retinopathy Study letters did not reach statistical significance (CI, 5.4 to 11.2, p<0.66). At 24 months, gains of >5 and >10 letters were significantly higher in the DHA supplementation group compared with controls when investigators considered worse-seeing and better-seeing eyes, but they did not find other differences at 12 months and 24 months.

Investigators found that intravitreal ranibizumab combined with DHA supplementation reduced central subfield macular thickness after two years of follow-up compared with ranibizumab alone in individuals with DME.

SOURCE: Lafuente M, Ortín L, Argente M, et al. Combined intravitreal ranibizumab and oral supplementation with docosahexaenoic acid and antioxidants for diabetic macular edema: Two-year randomized single-blind controlled trial results. Retina 2016; Oct 26. [Epub ahead of print].



Modified Canaloplasty: New Option for Glaucoma Cases With Disrupted Schlemm’s Canal Wall

Scientists described a modified canaloplasty technique and reported the short-term efficacy for primary open-angle glaucoma cases with disruption of Schlemm’s canal wall resulting from prior glaucoma surgery, as part of a single-surgeon, prospective cohort study.

They divided individuals with POAG who were scheduled for canaloplasty into two groups. Group 1 included POAG cases without a history of glaucoma surgery, and group 2 included POAG cases with failed glaucoma surgery and disrupted SC. Scientists determined the status of SC by gonioscopy and ultrasound biomicroscopy. They performed standard canaloplasty procedures in group 1 and a modified canaloplasty technique in group 2. Primary outcome measures included intraocular pressure and glaucoma medication use at various follow-up points.

Scientists enrolled 17 people in group 1 and nine in group 2. At the 12-month follow-up, scientists found no significant difference in IOP between groups 1 and 2 (17.8 ±2.7 mmHg vs. 16.7 ±2.4 mmHg, respectively; p=0.362) or in the mean number of medications (0.9 ±1.2 vs. 0.3 ±0.5, respectively; p=0.061). In both groups, at all follow-up points, the IOP and mean glaucoma medication usage decreased significantly compared with measurements at baseline (p<0.001). The rate for successful circumferential catheterization wasn’t significant between the two groups (88.2 percent vs. 77.8 percent, p=0.063).

Scientists suggested that modified canaloplasty is a feasible, safe and potentially effective option for individuals with POAG and regions of SC disruption resulting from previous glaucoma-filtering surgery.

SOURCE: Xin C, Chen X, Shi Y, et al. Modified canaloplasty: A new, effective, and safe option for glaucoma patients with a disrupted schlemm canal wall. J Glaucoma 2016;25;10:798-801.



Incidence & Growth of GA: Five Years of AMD Treatment Trials

Researchers estimated the incidence, size and growth rate of geographic atrophy during five years of follow-up among participants in the Comparison of Age-Related Macular Degeneration Treatments Trials, as part of a cohort within a clinical trial involving CATT participants.

They randomly assigned 1,185 CATT participants to ranibizumab or bevacizumab treatment and to three treatment regimens. They released participants from protocol treatment at two years and examined individuals at approximately five years (n=647). Two masked graders assessed the presence and size of GA in digital color photographs (CPs) and fluorescein angiograms (FAs) taken at baseline and at years one, two and five. Researchers used Cox proportional hazard models to identify risk factors for the incidence of GA. Annual change in the square root of the total area of GA served as the measure of growth. Researchers used multivariate linear mixed models, including baseline demographic, treatment and ocular characteristics on CP/FA, and optical coherence tomography as candidate risk factors to estimate adjusted growth rates, standard errors (SEs) and 95 percent confidence intervals. The main outcome measures were geographic atrophy incidence and growth rate.

Among the 1,011 participants who didn’t have GA at baseline and who had follow-up images gradable for GA, the cumulative incidence was 12 percent at one year, 17 percent at two years and 38 percent at five years. At baseline, factors including older age, hypercholesterolemia, worse visual acuity, larger choroidal neovascularization area, retinal angiomatous proliferation (RAP) lesion, GA in the fellow eye and intraretinal fluid were associated with a higher risk of incident GA. Thicker subretinal tissue complex and presence of subretinal fluid were associated with less GA development. The overall GA growth rate was 0.33 mm/year (SE, 0.02 mm/year). Eyes treated with ranibizumab in the first two years of the clinical trial had a higher growth rate than eyes treated with bevacizumab (adjusted growth rate, 0.38 vs. 0.28 mm/year; p=0.009). Researchers noted that GA in the fellow eye, hemorrhage and absence of subretinal pigment epithelium fluid at baseline were associated with a higher growth rate.

Researchers wrote that development of GA is common five years after initiating therapy and that several risk factors identified at two years of follow-up persisted at five years of follow-up.

SOURCE: Grunwald JE, Pistilli M, Daniel E, et al. Incidence and growth of geographic atrophy during 5 years of comparison of age-related macular degeneration treatments trials. Ophthalmology 2016; Sept 13. [Epub ahead of print].

 

 




  • Second Sight Announces CMS Hospital Outpatient Rate for Argus II CPT Codes
    Second Sight Medical Products announced that the Centers for Medicare & Medicaid Services finalized its Medicare hospital outpatient payment rate of $150,000.50 for 2017, which includes the cost of the Argus II Retinal Prosthesis System. In addition, the company announced that the American Medical Association Current Procedural Terminology Editorial Panel approved two new Category III CPT codes for initial programming and subsequent reprogramming of the Argus II. The codes will be published on January 1, 2017, and can be reported by clinicians beginning on July 1, 2017. Read more.



  • Topcon Introduces AIT-W1 and AIT-W2 Adjustable Instrument Tables
    Topcon Medical Systems introduced a series of adjustable instrument tables designed to maximize patient comfort and office space. The AIT-W tables, which come fully assembled and intended for easy setup, can support instruments up to 80 pounds and can be combined with Topcon instruments featuring rotating control panels such as the 3D OCT-1 Maestro, TRC-NW400, KR-1 and SP-1P. The AIT-W tables have no side legs or lateral supports for full wheelchair accessible, and feature a quiet and smooth elevation mechanism controlled from an illuminated touch panel. Three height memories can preset the table at different elevation levels, and an anti-collision system comes standard in the control unit software; an integrated sensor inside the AIT leg columns stops the down movement if the table comes in contact with a patient’s legs. Read more.



  • Study: iStent Reduced IOP & Medication Use in Predominantly Hispanic Glaucoma Population
    Glaukos announced that a study of 134 predominantly Hispanic eyes with open-angle glaucoma, published in Clinical Ophthalmology, showed mean intraocular pressure of 12.9 mmHg and a 61-percent decrease in mean medication burden one year following implantation of the iStent Trabecular Micro-Bypass Stent in combination with cataract surgery. The retrospective, consecutive case series included 168 eyes of 128 individuals who underwent iStent implantation with concomitant cataract surgery, of which 134 eyes in 100 individuals were followed for a year. Study researchers reported that 87 percent of subjects had moderate to severe OAG, and 80 percent were Hispanic. All procedures in the series were performed by Mark J. Gallardo, MD, at a single site in El Paso, Texas. Before surgery, individuals were placed into three subgroups in accordance with the surgeon’s typical clinical practice and based on the subject’s IOP level, medication burden and treatment goal. Read more.



  • Ophthotech Publishes Phase IIb Study Results
    Ophthotech Corp. announced that the Phase IIb study results of Fovista (pegpleranib), the company's anti-PDGF agent administered in combination with Lucentis (ranibizumab) anti-VEGF therapy for the treatment of wet age-related macular degeneration, were published online in Ophthalmology. The article reporting results of the prospective, randomized, controlled Phase IIb clinical trial of 449 individuals with wet AMD, revealed that Ophthotech’s Fovista (1.5 mg), administered in combination with Lucentis, met the prespecified primary efficacy endpoint of mean change in visual acuity. Individuals receiving the combination of Fovista (1.5 mg) and Lucentis (0.5 mg) gained a mean of 10.6 letters of vision on the ETDRS standardized chart at 24 weeks, compared with 6.5 letters for individuals receiving Lucentis monotherapy (p=0.019), representing a 62 percent additional benefit from baseline. No significant safety issues were observed for either treatment group in the trial. Read more.



  • Sixty Percent of Americans with Diabetes Skip Annual Eye Exams
    People with diabetes are at increased risk of developing serious eye diseases, yet most do not have annual eye exams, according to a large study presented at the American Academy of Ophthalmology annual meeting in Chicago. Researchers at Wills Eye Hospital found that more than half of individuals with the disease skip these exams. They also discovered that patients who smoke, and those with less severe diabetes and no eye problems were most likely to neglect the exams. Researchers collaborated with the Centers for Disease Control and Prevention to review the charts of nearly 2,000 individuals ages 40 or older with type 1 and type 2 diabetes. Read more.



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