From the editors of Review of Ophthalmology:
MARCH IS WORKPLACE EYE WELLNESS MONTH
In this issue: (click heading to view article)
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Topical Interferon Α2b as a Complementary Treatment of ME in DR
Researchers evaluated the effect of the topical interferon α2b as an adjunctive therapy in the treatment of diabetic macular edema, as part of a randomized controlled clinical trial performed on individuals with diabetic macular edema.
Fifty eyes of 50 DME patients (one eye/person) receiving therapy (the primary treatment for the DME wasn't specified in the abstract) were randomly assigned to get topical IFNα2b 1 MU/mL or artificial tear eye drops as adjunctive therapy. Primary measure outcomes were best-corrected visual acuity and central macular thickness; secondary goals were to assess the effect of topical IFNα2b on intraocular pressure and potential side effects. Here are some of the findings:
• Baseline demographic data of the two groups were similar.
• By the end of the fourth week, individuals on IFN experienced greater VA improvement, with more (6.85) Early Treatment Diabetic Retinopathy Study letters gained than individuals on artificial tears (1.45 ETDRS letters) (p=0.001);by the eighth week, individuals on IFN gained more ETDRS letters (6.75) than individuals on artificial tears (1.05 ETDRS letters) (p=0.005).
• Central macular thickness also decreased by the end of the fourth week (53.1 ±153 µm for individuals on IFN and 26.6 ±119.1 µm for individuals on artificial tears, p=0.497) and eighth week (27.9 ±67.7 for individuals on IFN and 29.2 ±98 µm for individuals on artificial tears, p=0.957), though the reduction wasn’t statistically significant.
• IOP was decreased on the fourth week in the IFN group (1.7 mmHg ±3) and increased in the artificial tear group (0.1 mmHg ±2.3) (p=0.018).
• No significant side effects were detected with topical IFN drops.
Researchers found topical IFNα2b 1 MU/mL was well-tolerated and might help improve BCVA in individuals with DME. They also reported an IOP lowering effect on the studied eyes, but suggested that further studies would be needed to confirm this finding.
SOURCE: Afarid M, Meshksar A, Salehi A. Evaluation of the effect of topical interferon α2b as a complementary treatment of macular edema of patients with diabetic retinopathy. Retina 2019; Feb 6. [Epub ahead of print].
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Macular Perfusion Changes Assessed with OCTA after Vitrectomy for RRD
Investigators explored whether macular perfusion changes in individuals with rhegmatogenous retinal detachment involved the macula following successful surgery, and evaluated the correlation between macular blood flow density and visual outcomes using optical coherence tomography angiography.
This retrospective study included 14 eyes (14 individuals) with macula-off RRD that underwent a standard three-port 23-gauge pars plana vitrectomy and intraocular gas tamponade combined with phacoemulsification, aspiration and intraocular lens implantation. OCTA was used to evaluate the macular perfusion changes throughout the postoperative 12 weeks in the superficial capillary plexus, deep capillary plexus and choriocapillary plexus. The fellow unaffected eyes were used as controls for comparison. Here were some of the findings:
• Investigators observed a significant increase in the superficial capillary plexus flow density (SCPFD) (p=0.000) over time in RRD eyes with successful PPV, as well as in the deep capillary plexus (DCPFD) (p=0.000) and choriocapillary plexus flow densities (CCPFD)(p=0.000).
• Final best-corrected visual acuity was positively associated with CCPFD (r=- 0.577; p=0.031), and non-correlated with SCPFD and DCPFD (p>0.05).
Investigators determined that macular perfusion gradually recovered after successful RRD repair by PPV. They added that OCTA provided a noninvasive method to explore the underlying reasons for different postoperative visual outcomes in macular-off RRD individuals.
SOURCE: Wang H, Xu X, Sun X, et al. Macular perfusion changes assessed with optical coherence tomography angiography after vitrectomy for rhegmatogenous retinal detachment. Graefes Arch Clin Exp Ophthalmol 2019; Feb. 22. [Epub ahead of print].
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Relationship Between OCTA Peripapillary Vessel Density & LC Depth
Scientists wrote that peripapillary vessel density assessed by optical coherence tomography angiography generally has poor global and regional correlations with lamina cribrosa depth, except at the inferotemporal area. They investigated the global and regional relationships between peripapillary vessel density (pVD) assessed by OCTA, and LC depth assessed by enhanced-depth imaging spectral-domain OCT.
Scientists included 38 eyes of 38 healthy subjects, and 38 eyes of 38 glaucoma patients. They imaged peripapillary microvasculature by OCTA, and LC by EDI SD-OCT. And they measured pVD and LCD at temporal, superotemporal, superonasal, nasal, inferonasal and inferotemporal sectors. Scientists evaluated global and regional correlations between pVD and LCD in all subjects. Here were some of the findings:
• The pVD (59 ±2.6 percent vs. 54.4 ±5.4 percent) and LCD (318.5 ±76.4 vs. 404.6 ±92.5 μm) were significantly different between healthy and glaucoma subjects.
• The average pVD assessed by OCTA wasn’t significantly correlated with average LCD assessed by SD-OCT (r=-0.160, p=0.167).
• Regional correlation between pVD and LCD was statistically significant only in the inferotemporal sector (r=-0.301 and p=0.008).
• In the linear regression analysis, reduced pVD was independently associated with decreased visual field mean deviation and peripapillary retinal nerve fiber layer thickness but not with increased LCD.
Scientists determined that global and regional correlations between pVD and LCD were poor except for at the inferotemporal sector. They wrote that the findings suggested that peripapillary microvascular impairment might not result directly from posterior LC displacement.
SOURCE: Eah KS, Shin JW, Sung KR. Relationship between optical coherence tomography angiography peripapillary vessel density and lamina cribrosa depth. J Glaucoma 2019; Feb. 21. [Epub ahead of print].
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Postoperative Endothelial Cell Density Associated with Late Endothelial Graft Failure after DSAEK
Researchers evaluated whether preoperative endothelial cell density and/or postoperative ECD after Descemet’s stripping automated endothelial keratoplasty were associated with late endothelial graft failure in the Cornea Preservation Time Study.
The cohort study within a multicenter randomized clinical trial enrolled 1,007 individuals (1,223 study eyes) with a mean age of 70 years, who were undergoing DSAEK for Fuchs’ dystrophy (94 percent) or pseudophakic/aphakic corneal edema (PACE) (6 percent) and followed for up to five years.
Central ECD was determined by a central image analysis reading center. Preoperative ECD was determined for 1,209 eyes that didn’t fail and 14 eyes that experienced LEGF. ECD at six and 12 months after DSAEK, change in ECD from preoperative to six and 12 months, surgeon-reported operative complications and postoperative graft dislocation were investigated for associations with LEGFs unrelated to other postoperative events. Univariable and multivariable Cox proportional hazards regression models were used to assess associations. Here were some of the findings:
• The cumulative probability of LEGF was 1.3 percent (CI, 0.8 to 2.4 percent).
• Median (IQR) preoperative ECDs were similar for eyes with LEGF (2,523 [2,367, 3,161] cells/mm2) and eyes without failure (2,727 [2,508, 2,973] cells/mm2) (p=0.34).
• ECD at six months was associated with LEGF (p<0.001) in time-to-event analyses, while preoperative ECD wasn’t (p=0.55).
• The cumulative incidence of LEGF was 6.5 percent (3 percent, 14 percent) for 97 grafts with a six-month ECD less than 1,200 cells/mm2; 0.3 percent (0.0 percent, 2.4 percent) for 310 grafts with a six-month ECD between 1,200 and 2,000 cells/mm2; and 0.6 percent (0.1 percent, 2.7 percent) for 589 grafts with a six-month ECD greater than 2,000 cells/mm2.
• In multivariable analyses, ECD at six months (p=0.002) and operative complications (p=0.01) were associated with LEGF, while graft dislocation wasn’t (p=0.61).
Researchers reported that preoperative ECD was unrelated to LEGF in eyes undergoing DSAEK, while lower ECD at six months was associated with LEGF. They recommended that early endothelial cell loss after DSAEK and intraoperative complications should be minimized to improve graft survival.
SOURCE: Patel SV, Lass JH, Benetz BA, et al. Post-operative endothelial cell density is associated with late endothelial graft failure after Descemet stripping automated endothelial keratoplasty. Ophthalmology 2019; Feb. 18. [Epub ahead of print].
B+L Gets FDA Nod for Lotemax SM
The FDA approved Bausch + Lomb’s Lotemax SM (loteprednol etabonate ophthalmic gel) 0.38%, a new gel formulation for the treatment of postoperative inflammation and pain following ocular surgery. The company says Lotemax SM uses novel SubMicron (SM) technology to control ocular pain and inflammation after all ocular surgeries. Compared with Lotemax Gel (loteprednol etabonate ophthalmic gel) 0.5%, the company says Lotemax SM delivers a submicron particle size for faster drug dissolution in tears and provides two times greater penetration to the aqueous humor. The company developed SM technology to adhere to the ocular surface and then penetrate key ocular tissues, B+L says. Read more.
Roche Enters into Merger Agreement to Acquire Spark
Roche and Spark Therapeutics announced that they entered into a definitive merger agreement for Roche to fully acquire Spark for approximately $4.3 billion. Spark Therapeutics was the first company to receive FDA approval for a gene therapy for a genetic disease in 2017 with Luxturna (voretigene neparvovec-rzyl). Luxturna, which is marketed by Spark, is a one-time gene therapy product indicated for the treatment of individuals with confirmed biallelic RPE65 mutation-associated retinal dystrophy. The company is also developing SPK-1001 for CLN2 disease (a form of Batten disease) as well as additional preclinical programs for Stargardt’s disease. Read more.
LumiThera Receives Notice of $2.5 Million NEI Grant Award
LumiThera is a recipient of a small business innovative research Phase II grant from the National Institutes of Health and the National Eye Institute to support a prospective, randomized, multicenter human clinical trial in U.S. subjects diagnosed with dry age-related macular degeneration. The LIGHTSITE III trial, which is subject to FDA Investigational Device Exemption approval, will test vision and examine disease pathology in eyes following PBM treatments using the company's Valeda Light Delivery System. Subjects will be followed for up to two years. Read more.
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