From the editors of Review of Ophthalmology:
AUGUST IS CHILDREN’S EYE HEALTH AND SAFETY MONTH
In this issue: (click heading to view article)
Sight Outcomes Data on Triaging Glaucoma Patients During Pandemics
During the novel-coronavirus pandemic, eye-care professionals caring for patients with sight-threatening diseases, such as glaucoma, have had to determine whether some patient appointments could safely get postponed, while weighing the risk that the patient’s glaucoma could worsen during the interim vs. the morbidity risk of acquiring COVID-19 while seeking ophthalmic care. Practices also have needed to prioritize appointment rescheduling during the ramp-up phase (when pandemic-associated service reductions are eased).
Researchers described a flexible and scalable scoring algorithm for patients with glaucoma that considers glaucoma severity and progression risk vs. the presence of high-risk features for morbidity from COVID-19, using information from a large data repository.
In this cross-sectional study, researchers identified patients with upcoming clinic appointments for glaucoma from March 16, 2020, to April 16, 2020, at an academic institution enrolled in the Sight Outcomes Research Collaborative (SOURCE) Ophthalmology Electronic Health Record Data Repository. The study authors developed a risk stratification tool that calculated a glaucoma severity and progression risk score, and a COVID-19 morbidity risk score. These scores were summed to determine a total score for each patient. Main outcomes and measures included total scores and percentages of clinic appointments recommended for rescheduling.
Among 1,034 individuals with upcoming clinic appointments for glaucoma, the mean age was 66.7 ±14.6 years, with 575 women (55.6 percent), 733 white individuals (71 percent) and 160 black individuals (15.5 percent). Here were some of the findings:
- The mean glaucoma severity and progression risk score was 4 ±14.4 points, the mean COVID-19 morbidity risk score was 27.2 ±16.1 points and the mean total score was 31.2 ±21.4 points.
- During pandemic-associated reductions in services, using total score thresholds of 0, 25 and 50 points identified 970 appointments (93.8 percent), 668 appointments (64.6 percent) and 275 appointments (26.6 percent), respectively, for postponement and rescheduling.
- The algorithm-generated total scores also helped prioritize appointment rescheduling during the ramp-up phase.
Researchers wrote that they developed and implemented a tool that considers the risk of underlying ophthalmic disease progression from delayed care receipt and the morbidity risk from COVID-19 exposure, facilitating the triage of upcoming ophthalmic appointments. They added that comparable approaches for other ophthalmic and nonophthalmic care during the COVID-19 pandemic and similar crises may be created using this methodology.
SOURCE: Bommakanti NK, Zhou Y, Ehrlich JR, et al. Application of the sight outcomes research collaborative ophthalmology data repository for triaging patients with glaucoma and clinic appointments during pandemics such as COVID-19. JAMA Ophthalmol 2020; July 17. [Epub ahead of print].
Complimentary CME Education Videos
F-DALK for Keratoconus: Multi-surgeon Results
Investigators compared the clinical outcomes in femtosecond laser-assisted deep anterior lamellar keratoplasty (F-DALK) to manual non-laser deep anterior lamellar keratoplasty (M-DALK) for keratoconus in a multi-surgeon public health care setting.
The single-center, comparative, retrospective interventional case series included consecutive cases of keratoconus treated with big-bubble F-DALK from August 1, 2015 to September 1, 2018, and big-bubble M-DALK from September 1, 2012, to September 31, 2016, at Moorfields Eye Hospital, London.
Data on preoperative status, operative details, intraoperative and postoperative complications, secondary interventions and visual outcomes were archived on a customized spreadsheet for analysis.
Investigators analyzed 58 eyes of 55 individuals who underwent F-DALK, and 326 eyes of 309 individuals who underwent M-DALK. Here were some of the findings:
- Intraoperative perforation of Descemet’s membrane occurred in 15/58 (25.9 percent) of F-DALK cases compared with 148/326 (45.4 percent) of M-DALK cases (p=0.006).
- Intraoperative conversion to PK was carried out in 2/58 (3.4 percent) of F-DALK cases compared with 80/326 (24.5 percent) of M-DALK cases (p=0.001).
- Post-ROS, 86.5 percent of F-DALK eyes had a CDVA of ≥20/40 (15 ±7.3 months after surgery) compared with 83.7 percent of M-DALK eyes (24.9 ±10.6 months) (p=0.825).
Investigators wrote that laser automation of some steps in DALK for keratoconus may reduce the rate of intraoperative Descemet’s perforation and the conversion to PK, in a multi-surgeon setting.
SOURCE: Gadhvi KA, Romano V, Fernández-Vega Cueto L, et al. Femtosecond laser assisted deep anterior lamellar keratoplasty for keratoconus: Multi-surgeon results. Am J Ophthalmol 2020; July 21. [Epub ahead of print].
Complimentary CME Education Videos
Prognostic Value of Peripheral Retinal Nonperfusion in DR Using Ultra-widefield Fluorescein Angiography
Scientists assessed the prognostic value of peripheral retinal nonperfusion in individuals with diabetic retinopathy, using ultra-widefield fluorescein angiography (UWFA).
The cross-sectional study included 78 treatment-naïve eyes with nonproliferative and proliferative diabetic retinopathy (NPDR and PDR). Eyes were divided into three groups: mild/moderate NPDR (n=31); severe NPDR (n=31); and PDR (n=16). Three nonperfusion variables were calculated, reflecting the proportion of nonperfused to visible retina based on initial UWFA: central nonperfusion (CNP) index; peripheral nonperfusion (PNP) index; and PNP ratio. Scientists evaluated the relationships between these indices, central subfield thickness (CST) and spectacle-corrected visual acuity (SCVA).
Here were some of the findings:
- CNP and PNP indices were significantly higher in the PDR group (p=0.007) vs. the mild/moderate NPDR group (0.008) but not in the PDR group (p=0.149) vs. severe NPDR group (p=0.535).
- A significant linear correlation was found between the CNP and PNP indices in the severe NPDR group (R2=0.141, p=0.041) and PDR group (R2=0.311, p=0.025).
- Nonperfusion predominance wasn’t statistically correlated with the presence of macular edema (p=0.058) or disorganization of retinal inner layers (p=1).
- In the severe NPDR group, scientists found a moderately positive correlation between the CNP index and CST (rs=0.496, p=0.019), and no correlation between the CNP index and SCVA (p=0.160) when controlling for CST.
- In the PDR group, a strong negative correlation between the PNP ratio and CST was found (rs=-0.659, p=0.014), but no correlation was observed between CNP index, CST and SCVA.
- In the PDR group, a positive correlation was found between the PNP index, and PNP ratio (rs=0.549, p=0.027) and SCVA (rs=0.626, p=0.010), even after controlling for CST (rs=0.599, p=0.040).
Scientists determined that higher amounts of retinal nonperfusion were seen in patients with more severe retinopathy. Further, increased CNP was associated with macular thickening and subsequent vision loss; and having predominantly PNP was independently associated with worse VA, regardless of macular thickness. Scientists suggested that further studies would be needed to investigate the role of PNP in vision loss in diabetic retinopathy.
SOURCE: Antaki F, Coussa RG, Mikhail M, Archambault C, Lederer DE. The prognostic value of peripheral retinal nonperfusion in diabetic retinopathy using ultra-widefield fluorescein angiography. Graefes Arch Clin Exp Ophthalmol 2020; Jul 16. [Epub ahead of print].
Early Changes on SD-OCT After Treatment with Intravitreal Aflibercept for nAMD
Researchers evaluated early changes on spectral-domain optical coherence tomography during the loading phase with intravitreal aflibercept therapy in individuals with neovascular age-related macular degeneration.
In the prospective, open-label, single-arm, multicenter study, nAMD patients who were anti-vascular endothelial growth factor treatment-naïve received three monthly initial doses of intravitreal aflibercept 2 mg. The primary outcome was the proportion of patients with dry SD-OCT at 12 weeks, defined as an absence of intraretinal edema, intraretinal cysts, subretinal fluid and subretinal pigment epithelium fluid.
Fifty eyes of 50 individuals were investigated. Here were some of the findings:
- At 12 weeks, 34 percent (17/50) had dry SD-OCT.
- Marked reductions were observed for all other SD-OCT parameters. Mean macular central thickness fell significantly from 463.2 ±184.3 µm at baseline to 288.9 ±76.8 µm at week 12 (p<0.0001).
- Mean best-corrected visual acuity also improved significantly from 61 ±16 letters at baseline to 66.6 ±19 letters at week 12 (p=0.0006).
Researchers found that the anatomic and functional outcomes improved over the 12-week study period. All outcome variables peaked after the third aflibercept injection, confirming the benefit of three initial doses.
Source: Korobelnik J-F, Souied EH, Oubraham H, et al. Assessment of early changes in spectral domain-optical coherence tomography (SD-OCT) after initiation of treatment with intravitreal aflibercept (Eylea) over a 12-week period for patients with neovascular age-related macular degeneration. Retina 2020; July 13. [Epub ahead of print].
jCyte Announces Phase IIb Results of jCell Therapy
jCyte says that the recently announced results from its Phase IIb clinical trial of jCell have been “promising.” Jcell is a first-in-class investigational treatment for retinitis pigmentosa that has received FDA Regenerative Medicine Advanced Therapy and Orphan Drug designations. The trial was a multicenter, randomized study evaluating the safety and efficacy of intravitreal injection of jCell therapy vs. sham in adult subjects with RP. Individuals with RP with best-corrected visual acuity between 20/80 and 20/800 were randomized to treatment vs. sham. Treatment consisted of a single intravitreal injection of either three or six million human retinal progenitor cells. The study evaluated changes in visual function and functional vision in subjects with RP who received a single jCell injection in comparison to a sham-treated control group. In the 74 patients who met criteria per-protocol analysis, the mean changes in BCVA from baseline to month 12 were: +2.81, +2.96 and +7.43 letters in the sham arm (n=26); and 3 x 106 hRPC (n=25) and 6 x 106 hRPC (n=23) in the treatment arm, respectively. Read more.
Aerie Reports Topline Results for AR-1105 Phase II Trial
Aerie Pharmaceuticals reported topline results from its Phase II clinical trial evaluating AR-1105 (dexamethasone intravitreal implant) in individuals with macular edema associated with retinal vein occlusion. The trial’s objective was to evaluate two formulations of AR-1105 with different steroid release profiles. In the initial safety stage, five patients were enrolled in a single cohort to receive a 340 µg dose of dexamethasone in a single intravitreal injection. In stage two, 44 patients were randomized 1:1 to receive either formulation. The company says that the results demonstrated positive and sustained treatment effects with both formulations. Peak efficacy was observed earlier with the first formulation, while the second demonstrated a longer overall duration of effect of up to six months. Read more.
4D Molecular Therapeutics Doses First Patient in Phase I Clinical Trial of 4D-110
4D Molecular Therapeutics announced the first patient was dosed in its Phase I clinical trial of 4D-110, a Roche-licensed product candidate delivered by a single intravitreal injection for choroideremia. The open-label, dose-exploration and
-expansion study is expected to enroll up to 15 patients with choroideremia. Read more.
Review of Ophthalmology® Online is published by the Review Group, a 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 email@example.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 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