From the editors of Review of Ophthalmology:
Monday, November 12, 2018
NOVEMBER IS DIABETIC EYE DISEASE AWARENESS MONTH
In this issue: (click heading to view article)
Triamcinolone Acetonide as Adjunctive Treatment to PRP Using Pattern Scan Laser for DR
Researchers looked at the effect of sub-Tenon’s capsule triamcinolone acetonide injections combined with panretinal photocoagulation using pattern scan lasers for high-risk, non-proliferative diabetic retinopathy, in terms of inflammation and the progression of diabetic macular edema.
In the retrospective comparative analysis, individuals with NPDR who underwent PRP using PSL with (STTA+PSL group, n=24) or without (PSL group, n=19) STTA pretreatment were enrolled. Researchers measured anterior flare intensity and central retinal thickness (CRT) on the day of STTA, and at one, three, seven, 11 and 15 weeks.
- The CRT of the STTA+PSL group was significantly lower than that of the PSL group at seven (308.15 ±69.16 μm vs. 340.21 ±77.91 μm, p=0.04); 11 (283.8 ±60.75 μm vs. 335.7 ±67.70 μm, p=0.01); and 15 weeks (281.13 ±35.29 μm vs. 316.58 ±54.89 μm, p=0.02).
- AFI levels in the STTA+PSL group were significantly lower than those in the PSL group at 11 (10.47 ±3.40 vs. 15.85 ±8.38, p=0.007) and 15 weeks (11.38 ±3.31 vs. 14.37 ±3.85, p=0.009).
- The significant improvement in CRT from baseline was noticed through the observational periods in STTA+PSL group, but not in the PSL group.
Researchers concluded that pretreatment of sub-Tenon’s capsule triamcinolone acetonide could potentially prevent the worsening of DME and reduce the CRT and anterior flare intensity of eyes with NPDR after PRP using PSL.
SOURCE: Yamada Y, Takamura Y, Matsumura T, et al. Posterior subtenon infusion of triamcinolone acetonide as adjunctive treatment to panretinal photocoagulation using pattern scan laser for diabetic retinopathy. Jpn J Ophthalmol 2018; Oct 17. [Epub ahead of print].
Corneal Curvature & Optical Zone Decentration Impact on Astigmatism & HOAs in SMILE, LASIK
Investigators determined the association between anterior corneal curvature and optical zone centration, and the resulting impact on aberration profiles in small-incision lenticule extraction and laser in situ keratomileusis.
Seventy-eight eyes of 78 individuals treated with SMILE (45 eyes) and LASIK (33 eyes) were included. The centration of the optical zone was evaluated on the instantaneous curvature difference map between the preoperative and three-month postoperative scans using a superimposed set of concentric circles. Investigators evaluated the correlation between optical zone decentration and anterior keratometry values. They assessed the effect of optical zone decentration on vector components of astigmatic correction and induction of higher order aberrations.
- The mean decentration distance was 0.21 ±0.11 mm for SMILE and 0.20 ±0.09 mm for LASIK (p=0.808).
- A significant correlation was found between anterior keratometric astigmatism and decentration distance (r=0.653, p<0.001) for SMILE but not LASIK (r=-0.264, p=0.138).
- In 67 eyes that received astigmatic correction, optical zone decentration and the vector components of astigmatic correction weren’t correlated (p≥0.420).
- A significant correlation was demonstrated between the decentration distance and induced total coma (SMILE: r=0.384, p=0.009; LASIK: r=0.553, p=0.001) as well as induced total HOA (SMILE: r=0.498, p=0.001; LASIK: r=0.555, p=0.001).
Investigators determined that anterior corneal astigmatism affected the treatment centration in SMILE but not LASIK. They added that subclinical decentration was associated with the induction of total coma and total HOA, but it didn’t affect the lower-order astigmatic correction.
Source: Chan TCY, Wan KH, Kang DSY, et al. Effect of corneal curvature on optical zone decentration and its impact on astigmatism and higher-order aberrations in SMILE and LASIK. Graefes Arch Clin Exp Ophthalmol 2018; Oct 27. [Epub ahead of print].
Corneal Endothelial Cell Loss After Trabeculectomy With MMC
Scientists investigated factors associated with decreased corneal endothelial cell density after trabeculectomy with mitomycin C, as part of a retrospective review of consecutive individuals with glaucoma who underwent trabeculectomy with MMC.
The types of glaucoma included were primary open-angle glaucoma, exfoliation glaucoma (XFG), neovascular glaucoma (NVG) and uveitic glaucoma (UG). Scientists compared preoperative and postoperative ECD changes, and analyzed risk factors for ECD decrease using mixed-effects models.
A total of 162 eyes of 136 individuals were included. Postoperative ECD measurements were performed 3.7 ±1.8 times (mean ±SD) during a median follow-up period of 34 months.
- The mean intraocular pressure decreased from 25.3 ±9.6 mmHg to 9.2 ±2.3 mmHg postoperatively.
- The marginal mean (standard error) ECD decrease at 24 months was 9.3 (1.3) percent in all cases.
- The marginal mean ECD decrease at 24 months was 18.2 (3.1) percent in eyes with XFG and 20.6 (4.7) percent in eyes with and UG, which was significantly greater than 4.8 (1.8) percent in eyes with POAG (p<0.001, each), after accounting for the variability in the number and time point of ECD measurements.
- Multivariate mixed-effects model analyses showed that type of glaucoma (XFG and UG) and older age were significantly associated with larger ECD decrease, and preoperative factors (oral carbonic anhydrase inhibitor and vitrectomy) and postoperative choroidal detachment were significantly associated with a declining trend of ECD over time.
Scientists wrote that the type of glaucoma (XFG, UG) and older age were risk factors for larger ECD decease after trabeculectomy with MMC.
SOURCE: Higashide T, Nishino T, Sakaguchi K, et al. Determinants of corneal endothelial cell loss after trabeculectomy with mitomycin C. J Glaucoma 2018; Oct 11. [Epub ahead of print].
Ranibizumab Plus L-CRA vs. Ranibizumab Monotherapy for CRVO
Researchers wrote that adding a laser-induced chorioretinal anastomosis to treatments for central retinal vein occlusion might improve outcomes and lessen therapy burdens. They aimed to determine the two-year efficacy of intravitreal ranibizumab with an L-CRA vs. ranibizumab alone for individuals with macular edema caused by CRVO.
In this randomized clinical trial conducted at a single university clinic from March 2012 to June 2015, 58 participants with macular edema caused by CRVO were randomized 1:1 to either an L-CRA or sham procedure at baseline. All participants received monthly intravitreal injections of ranibizumab, 0.5 mg. Data were analyzed from April 2017 to September 2017.
Interventions included random assignment to L-CRA plus monthly injections of intravitreal ranibizumab, 0.5 mg, (combination group; n=29) or to a sham L-CRA procedure plus monthly injections of intravitreal ranibizumab 0.5 mg (ranibizumab-alone group; n=29) for six months. From month seven to 24, participants were evaluated monthly and received an injection of ranibizumab if a loss of five or more letters of best-corrected visual acuity on the ETDRS chart from their previous highest score occurred or if there was evidence of residual macular edema on optical coherence tomography. Main outcomes and measures included the mean number of injections from month seven to 24, and changes in BCVA and central subfield thickness.
Of 58 participants, 38 (66 percent) were men, and the mean (SD) age was 68.6 (11.8). Participants had a mean (SD) BCVA of 57.09 (11.87) ETDRS letters (Snellen equivalent, 20/73) and a mean (SD) CST of 738.36 (175.54) μm. A successful L-CRA was created in 24 of 29 participants (83 percent) in the combination group.
- The mean number of injections from month seven to 24 was 3.2 (CI, 2.5 to 3.8) in the combination group and 7.1 (CI, 6 to 8) in the ranibizumab-alone group.
- The ratio of the number of injections in the combination group compared with the ranibizumab alone group was 0.46 (CI, 0.36 to 0.61; p<0.001).
- Mixed-effects regression modeling showed a difference in mean BCVA at two years between the combination and ranibizumab-alone groups (combination, 70.3 letters [Snellen equivalent, 20/40]; ranibizumab alone, 61.6 letters [Snellen equivalent, 20/60]; difference, 8.8 letters; CI, 0.2 to 17.3; p=0.05).
- Researchers detected a difference in CST at two years between the combination and ranibizumab-alone groups (mean CST: combination, 303.6 μm; ranibizumab alone, 394.5 μm; difference, 90.9 μm; CI, 24.3 to 157.5; p=0.01).
- Four participants (14 percent) in the combination group required a vitrectomy for early macular traction or vitreous hemorrhage.
Researchers wrote that, for macular edema caused by CRVO, an L-CRA significantly reduced the number of ranibizumab injections required.
SOURCE: McAllister IL, Smithies LA, Chen FK, et al. Two-year efficacy of ranibizumab plus laser-induced chorioretinal anastomosis vs ranibizumab monotherapy for central retinal vein occlusion. JAMA Ophthalmology 2018; Oct. 18. [Epub ahead of print].
Clearside: SAPPHIRE Phase III Study of Combination Therapy in RVO Fails to Meet Primary Endpoint
Clearside Biomedical announced that the primary endpoint wasn’t achieved in its Phase III clinical trial (SAPPHIRE) investigating the superiority of Xipere (formerly “suprachoroidal CLS-TA”) used with the intravitreal anti-VEGF agent Eylea (aflibercept) compared with intravitreal Eylea monotherapy for the treatment of retinal vein occlusion. The primary endpoint the treatment failed to meet was the proportion of individuals in the combination treatment arm compared with the intravitreal Eylea-alone control arm, with improvements in best-corrected visual acuity from baseline of at least 15 letters on the Early Treatment Diabetic Retinopathy Study scale at eight weeks after initial treatment. The company says it will discontinue clinical development of combination therapy for RVO, which includes SAPPHIRE and its companion Phase III clinical trial, TOPAZ. Read more.
Ocular Therapeutix Announces Positive Results of Phase IIIc Study
Ocular Therapeutix announced that primary endpoints were met in a multicenter, Phase III study of its sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. The parallel-arm, double-masked, vehicle-controlled study randomized individuals who received either dexamethasone insert or placebo. The study also found that people receiving the dexamethasone insert experienced a decrease in inflammation after surgery as early as day four through day 45, and a decrease in pain as early as one day after surgery through day 45. The dexamethasone insert was well-tolerated, and the adverse events profile was similar to placebo. Read more.
Zeiss Introduces Advances in Glaucoma Imaging & Astigmatism Management
At the American Academy of Ophthalmology annual meeting in Chicago, Zeiss launched Total Keratometry for the IOLMaster 700, which it says offers cataract surgeons the opportunity to obtain precise measurements of the posterior corneal surface. TK was developed to be compatible with standard formulas and existing IOL constants, to enable surgeons to detect outlier cases with minimal disruptions to existing workflows, Zeiss says. The device also includes two new Barrett formulas incorporating the new TK value.
Furthermore, Zeiss announced the FDA approval of ReLEx Small Incision Lenticule Extraction (SMILE) to expand myopia treatment to individuals with astigmatism. SMILE utilizes the femtosecond laser VisuMax to enable surgeons to create a lenticule inside the cornea and access incisions in a single treatment step.
Finally, Zeiss introduced the Advanced Nerve and Glaucoma Imaging Network, which is led by an independent, worldwide group of doctors and clinical researchers. Read more.
Vital Tears Adds Mobile Phlebotomy Services to Aid ECPs & DED Patients
Vital Tears announced the addition of mobile phlebotomy services to its system of providing autologous serum tears for dry eye therapy. By offering mobile phlebotomy services, patients can have blood drawn in the comfort and convenience of their own home or office, the company says. Autologous serum tears have long been studied and used by eye-care professionals as an option for patients with ocular surface disease symptoms and dry eye. However, the company says that the cost and logistics of processing the tears made from a patient’s blood serum proved cumbersome for many. In 2015, Vital Tears introduced a system of production, delivery and billing, increasing access to the customized therapy. Read more.
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