From the editors of Review of Ophthalmology:
JUNE IS FIREWORKS EYE SAFETY & CATARACT AWARENESS MONTH
In this issue: (click heading to view article)
Effectiveness of iStent vs. Phacoemulsification Among Mild, Moderate & Severe POAG Patients
Researchers compared one-year effectiveness of single trabecular microbypass stent (iStent) implantation with phacoemulsification in primary open-angle glaucoma. They evaluated the iStent in combination with cataract surgery in moderate to severe glaucoma vs. mild glaucoma.
Researchers retrospectively reviewed medical charts of POAG subjects undergoing one iStent implantation. Glaucoma was classified on the basis of mean deviation of the preoperative standard automated perimetry as mild (MD ≥6 dB), moderate (MD, -6 to -12 dB) and severe (MD ≤12 dB). Researchers performed mixed effect regression models to determine the effect of iStent at one year. The outcomes included:
- (1) intraocular pressure and the number of medications,
- (2) eyes with IOP ≤severity-based target (18 mmHg for mild, 15 mmHg for moderate and 12 mmHg for severe)
- (2A) without medication, and
- (2B) with medication reduction.
In total, 104 eyes from 89 subjects were analyzed. Here were some of the findings:
- Cataract combined with iStent surgery significantly lowered the number of medications in all groups and significantly decreased IOP in moderate and severe glaucoma (p<0.05).
- A significantly higher number of medications was found in moderate (β: 0.58, p=0.002) and severe (β: 1.20, p<0.001) glaucoma compared with mild glaucoma.
- Eyes with moderate glaucoma had significantly lower rates of success (criterion 2A) compared with mild glaucoma (OR, 0.008; p=0.047).
- Eyes with moderate and severe glaucoma had significantly lower rates of success (criterion 2B) (moderate vs. mild: OR, 0.002; p=0.028; severe vs. mild: OR, 0.026; p=0.026).
Researchers wrote that, in real-world data over a one-year follow-up period, combined phacoemulsification with iStent appeared to have better IOP- and medication-lowering effects in mild vs. moderate and severe cases of glaucoma. Researchers advised that long-term studies with defined IOP goals and medication removal protocols would be warranted to confirm the findings.
Source: Chansangpetch S, Ittarat M, Yang S, et al. Comparison of 1-year effectiveness of trabecular microbypass stent implantation (iStent) in conjunction with phacoemulsification among mild, moderate, and severe primary open-angle glaucoma patients. J Glaucoma 2020; May 19. [Epub ahead of print].
Complimentary CME Education Videos
Deep Learning Automated Detection of Reticular Pseudodrusen from Fundus Autofluorescence Images or Color Fundus Photographs in AREDS2
Investigators developed and evaluated deep learning models for detecting reticular pseudodrusen (RPD) using fundus autofluorescence (FAF) images or color fundus photographs (CFP), in the context of age-related macular degeneration.
They applied deep learning models to the Age-Related Eye Disease Study 2 (AREDS2) dataset, and included 11,535 FAF and 11,535 CFP images from longitudinal follow-up of 2,450 participants in the AREDS2 dataset. They derived Gold standard labels from reading center grading of the FAF images and transferred them to the corresponding CFP images. And they trained a deep learning model to detect RPD in eyes with intermediate to late AMD, using FAF images (FAF model). Using labels transferred from FAF to corresponding CFP images, they trained a second deep learning model to detect RPD from CFP (CFP model). Investigators compared model performance with that of four ophthalmologists using a random subset from the full test set. Main outcome measures included area under the curve; kappa; accuracy; and F1-score.
Here were some of the findings:
- On the full test set, the FAF model had:
- AUC: 0.939 (CI, 0.927 to 0.950);
- kappa: 0.718 (CI, 0.685 to 0.751);
- accuracy: 0.899 (CI, 0.887 to 0.911); and
- F1-score: 0.783 (CI, 0.755 to 0.809).
- The CFP model had equivalent values of:
- AUC: 0.832 (CI, 0.812 to 0.851);
- kappa: 0.470 (CI, 0.426 to 0.511);
- accuracy: 0.809 (CI, 0.793 to 0.825); and
- F1-score: 0.593 (CI, 0.557 to 0.627).
- The FAF model demonstrated superior performance to four ophthalmologists on the random subset, showing:
- higher kappa of 0.789 (CI, 0.675 to 0.875) vs. range CI, 0.367 to 0.756;
- higher accuracy of 0.937 (CI, 0.907 to 0.963) vs. range CI, 0.696 to 0.933; and
- higher F1-score of 0.828 (CI, 0.725 to 0.898) vs. range 0.539 to 0.795.
- The CFP model demonstrated superior performance to four ophthalmologists on the random subset, showing:
- higher kappa of 0.471 (CI, 0.330 to 0.606) vs. range CI, 0.105 to 0.180;
- higher accuracy of 0.844 (0.798-0.886) vs. range CI, 0.717 to 0.814; and
- higher F1-score of 0.565 (CI, 0.434 to 0.674) vs. range CI, 0.217 to 0.314.
Investigators found that deep learning-enabled automated detection of RPD presence from FAF images achieved a high level of accuracy—equal or superior to that of ophthalmologists. They also reported that automated RPD detection using CFP achieved a lower accuracy that still surpassed that of ophthalmologists. As such, the investigators determined that deep learning models can assist, and even augment, the detection of this AMD-associated lesion.
SOURCE: Keenan TD, Chen Q, Peng Y, et al. Deep learning automated detection of reticular pseudodrusen from fundus autofluorescence images or color fundus photographs in AREDS2. Ophthalmology 2020; May 20. [Epub ahead of print].
Complimentary CME Education Videos
Descemet Membrane Detachment After Penetrating Keratoplasty for Keratoconus
Scientists described the risk factors, management and outcomes of delayed Descemet’s membrane detachment after penetrating keratoplasty for keratoconus.
They looked at seven eyes from six cases and combined the data with seven previous case reports identified by a search of PubMed. Here were some of the findings:
- DM detachment occurred at a median of 25 years (range, seven to 33 years) after PK.
- One individual had bilateral detachments.
- Individuals typically experienced a mild ocular discomfort sometimes accompanied by a rapid onset of visual blur.
- Cases were often treated for allograft rejection before a DM detachment was suspected and confirmed by optical coherence tomography.
- Detachments were limited to the donor tissue in 11 eyes, but a DM break was identified at the time of onset in four eyes.
- Thinning of the host corneal rim with ectasia was reported in eight eyes (57 percent).
- In three eyes, the detachment resolved spontaneously, but in two eyes, a detachment was still present at 12 months.
- Gas tamponade to reattach the DM was performed in nine eyes and was effective in four eyes.
- Five eyes underwent a repeat PK or endothelial keratoplasty.
- Histology showed fibroblastic proliferation on the stromal surface of the folded DM.
Scientists wrote that the cause of DM detachment years after PK is unknown, although they suggested that progressive thinning of the host cornea and secondary graft ectasia may be an issue. They added that gas tamponade can be effective, but a repeat keratoplasty may be necessary. Furthermore, scientists wrote, DM detachment should be included in the differential diagnosis for late-onset corneal edema after PK.
SOURCE: Kit V, Kriman J, Vasquez-Perez A, et al. Descemet membrane detachment after penetrating keratoplasty for keratoconus. Retina 2020; May 7. [Epub ahead of print].
“Trinity” Regimen with Aflibercept for Treatment-naïve nAMD: 2-Year Outcomes
Researchers evaluated the advantages of the so-called trinity regimen for treatment-naïve neovascular age-related macular degeneration, which involves using three treatment methods— pro re nata, treat-and-extend (TAE) and fixed regimen—that are changed depending on recurrence frequency. Thirty-one treatment–naïve nAMD eyes were treated using the novel regimen with an intravitreal aflibercept injection and evaluated after 24 months.
After the initial treatment, PRN or TAE (for four or eight weeks) were selected per the recurrence interval. When the recurrence interval became constant, the treatment regimen was transitioned from a TAE to a fixed regimen. When the recurrence frequency became irregular, it was changed to TAE. Here were some of the findings:
- After the initial treatment:
- 15 eyes (48.4 percent) were assigned to the PRN group;
- 12 (38.7 percent) were assigned to the TAE eight-week group; and
- four (12.9 percent) were assigned to the TAE four-week group.
- Mean logMAR vision significantly improved from 0.53 ±0.40 at baseline to 0.36 ±0.34 at 24 months (p<0.01) (from a little worse than 20/63 at baseline to just above 20/50):
- in the PRN group, it went from 0.63 ±0.46 to 0.42 ±0.43, (p<0.01) (from a little worse than 20/80 at baseline to a bit worse than 20/50); and
- in the TAE eight-week group it improved from 0.44 ±0.29 to 0.27 ±0.19 (p<0.05) (from a little worse than 20/50 at baseline to just above 20/40).
- LogMAR visual acuity in the TAE four-week group was maintained.
- The mean number of injections were: for all, 9.7; PRN, 5.3; TAE 8-week, 13.1; and TAE four-week group 15.8, with the PRN group being significantly less (p<0.01).
Researchers concluded that the trinity regimen delivered the benefits of the PRN, TAE and fixed regimens while minimizing injections during the early treatment phase without visual loss.
SOURCE: Wakuta M, Nomi M, Ogata T, et al. A Trinity regimen with aflibercept for treatment-naïve neovascular age-related macular degeneration: 2-year outcomes. Graefes Arch Clin Exp Ophthalmol 2020; May 21. [Epub ahead of print].
FDA Accepts NDA for Eysuvis
Kala Pharmaceuticals announced the FDA accepted for review the company’s New Drug Application resubmission for Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25%, its product candidate for the short-term treatment of the signs and symptoms of dry-eye disease. This comes following last August’s rejection of the application via an FDA Complete Response Letter. The agency now says that the NDA resubmission is a complete, class 2 response to the Complete Response Letter, and it has set a Prescription Drug User Fee Act goal date of Oct. 30 for its completion of the NDA review. Read more.
Samsung Bioepis Announces Interim Results from Phase III Proposed Ranibizumab Biosimilar Trial
Samsung Bioepis announced the primary endpoints were met in the randomized, double-masked Phase III trial comparing the efficacy, safety and immunogenicity of SB11, a ranibizumab biosimilar candidate in patients with neovascular age-related macular degeneration. The company says the study achieved its primary endpoints—change from baseline in best-corrected visual activity at week eight and central subfield thickness at week four. Read more.
Eye Designs Forms In-office Sterilization Division
Eye Designs, a manufacturer of custom ophthalmic offices and optical display systems, says it’s formed of a new in-office sterilization division to deliver solutions and products to ophthalmology offices so they can “re-open with confidence.” The company says the offering is focused on several key areas: prevention and elimination of germs and viruses; and providing confidence in key components that ensure a sterile operating environment. Learn more.
Kubota Continues Development of Eyeglasses to Stop Myopia Progression
Though it didn’t share the full data, Kubota Vision announced positive clinical results from small (12 adults), initial myopia control tests. Using electronic tabletop optical projection devices that use Kubota Glasses technology, myopically defocused images were projected on the peripheral retina of subjects to see if this might prevent the progression of myopia. Based on the positive clinical results from adult subjects, Kubota says it will accelerate the program to develop wearable devices to try to prevent myopia in children. Read more.
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