From the editors of Review of Ophthalmology:
JUNE IS FIREWORKS EYE SAFETY & CATARACT AWARENESS MONTH
In this issue: (click heading to view article)
Long-term Intravitreal Anti-VEGF Injections for Wet AMD
Researchers determined the long-term visual outcomes and intravitreal injection burden of individuals with exudative age-related macular degeneration treated with intravitreal anti-vascular endothelial growth factor injections, as part of a retrospective, cohort study.
Participants included individuals with exudative AMD treated with intravitreal anti-VEGF injections with annual office visits for at least seven years.
Researchers measured Snellen visual acuity at baseline and then annually until the last year of follow-up. The number of injections was recorded on an annual basis during each year of follow-up. Main outcome measure included the change in the frequency of injections over time along with the change in visual acuity each year from the baseline visit up through seven years.
During this time, a total of 533 eyes of 429 patients were treated for wet AMD. Of these eyes, 391 eyes (73 percent) met the inclusion criteria of annual office visits. Here were some of the findings:
• These included eyes received a mean of 5.8 ±2.5 intravitreal injections per year.
• The baseline mean logMAR visual acuity was 0.6 ±0.5 (Snellen acuity 20/80), and the seven-year logMAR visual acuity was 0.8 ±0.6 (20/126; p<0.0001).
• When compared to the 142 eyes that went more than a continuous 12-month period without an office visit, eyes with annual office visits had similar baseline mean visual acuity (0.7 logMAR vs. 0.6 logMAR; p=0.2102), but more injections per year (p<0.0001).
• Of the 533 total eyes, 124 eyes (23 percent) maintained better than 20/40 visual acuity at seven years.
• These eyes received more injections overall per year (6.5 vs. 5.5 per year; p=0.0007).
In a real-world setting, researchers found that eyes that maintained consistent, long-term follow-up received a significant number of intravitreal injections per year—significantly more than eyes with inconsistent follow up. They also reported that eyes with 20/40 or better vision at the study’s conclusion received more injections per year than eyes with worse than 20/40 vision.
Source: Kung FF, Starr MR, Bui YT, et al. Long term follow-up of patients with exudative age-related macular degeneration treated with intravitreal anti-vascular endothelial growth factor injections. Ophthalmology Retina 2020; May 18. [Epub ahead of print].
Complimentary CME Education Videos
Patient Reported Outcomes in Microbial Keratitis
Investigators aimed to study patient-reported outcomes of patients with microbial keratitis using the 9-item National Eye Institute-Visual Function Questionnaire (NEI VFQ-9).
Using the Sight Outcomes Research Collaborative ophthalmology electronic health record repository, investigators identified patients with MK and controls who completed the NEI VFQ-9 within seven days of their appointments. (The questionnaire is scored as a mean of the nine items on a scale from 0 to 100, with higher scores indicating better functioning.) Composite and individual item scores were compared between groups using the analysis of variance.
In total, 916 questionnaires were completed from: patients with acute MK (n=84); nonacute MK (n=30); MK with a corneal transplant (n=21); and controls seen in a satellite comprehensive ophthalmology clinic (n=528) in addition to controls seen at a subspecialty ophthalmology clinic (n=253).
Here were some of the findings.
- The mean NEI VFQ-9 composite scores per group were:
- patients with acute MK: 66.6 ±26.8;
- patients with nonacute MK: 78.1 ±17.1;
- patients with MK with a corneal transplant: 58.6 ±21.6;
- controls seen in a satellite comprehensive ophthalmology clinic: 88 ±10.2; and
- controls seen at a subspecialty ophthalmology clinic: 83.5 ±13 (p< 0.0001).
- Patients with acute MK and MK requiring transplant reported significantly worse function than nonacute MK, comprehensive and specialty patients.
- Patients with nonacute MK reported significantly worse function than comprehensive control patients (p<0.05).
Investigators wrote that patients who had or eventually required corneal transplant for management of their MK reported worse visual function than patients with nonacute MK. They suggested that this may be important in helping physicians counsel their patients.
SOURCE: Tuohy MM, Niziol LM, Shazhad IM, et al. Patient reported outcomes in microbial keratitis. Cornea 2020; June 1. [Epub ahead of print].
Complimentary CME Education Videos
Fluctuations in Macular Thickness in RVO Treated with Anti-VEGF Agents
Scientists evaluated macular thickness fluctuations in individuals with retinal vein occlusions treated with anti-vascular endothelial growth factor agents, and assessed whether patients with larger fluctuations had poorer visual outcomes, as part of a retrospective cohort study.
Participants included treatment-naïve patients with RVO followed over 12 months of treatment.
From optical coherence tomography technology, scientists collected central subfield thickness (CST), cube volume (CV) and cube average thickness (CAT) at baseline, three, six, nine and 12 months. They calculated standard deviations across 12 months. And they performed mixed effects regression to examine the relationship between macular thickness SD and 12-month visual acuity. In addition, they performed standard multiple regression to identify predictors of macular thickness SD.
Main outcome measures included SD across 12 months for CST, CV and CAT; and VA at 12 months. Scientists evaluated 134 eyes, including 71 branch RVO and 63 central RVO. Here were some of the findings:
- Mean baseline CST was 488.6 ±165 and mean 12-month CST was 334.3 ±131.9 (change= -154.3 ±210.2, p<0.001); CST SD was 114.1 ±77 μm.
- Baseline VA was 52.8 ±20.9 and 12-month CST was 65.9 ±17.3 (change= +13.1 ±20.3 letters; p<0.001).
- CST SD was a significant negative predictor of 12-month VA (p=0.041) when adjusting for baseline factors and injections.
- Baseline CST and number of injections weren’t predictive (p≥0.101).
- Stratification by CST SD demonstrated 10 letters difference in 12-month VA between first and fourth quartiles.
- Baseline CST and RVO diagnosis were the only significant predictors of CST SD (p<0.001) vs. BRVO (p=0.013). Associations using CV and CAT were similar.
Scientists reported that larger macular thickness fluctuations were associated with poorer visual outcomes in patients with RVO treated with anti-VEGF agents. They added that macular thickness fluctuations in addition to absolute macular thickness may be important prognostic biomarkers in these patients.
SOURCE: Chen AX, Greenlee TE, Conti TF, et al. Fluctuations in macular thickness in patients with retinal vein occlusion treated with anti-vascular endothelial growth factor agents. Ophthalmology Retina 2020; May 28. [Epub ahead of print].
24-Hour IOP-related Patterns from Contact Lens Sensors in NTG & Healthy Eyes: The ENIGMA Study
Researchers analyzed 24-hour nyctohemeral intraocular pressure-related patterns with Triggerfish (Sensimed) contact lens sensors (CLS) in eyes with primary open-angle glaucoma with normal baseline IOP (i.e., normal-tension glaucoma) and healthy controls, as part of a small, prospective, case-control study sponsored by Handok, a distributor of the Triggerfish device.
Participants included 30 eyes of 30 NTG patients who had a washout period for their IOP-lowering treatments, and 20 eyes of 20 healthy volunteer subjects.
Individuals were hospitalized for 24-hour CLS measurements using the Sensimed Triggerfish system. Researchers compared IOP-related patterns during wake and sleep times over the course of 24 hours between the two groups. In addition, 24-hour ambulatory blood pressure and posture were monitored simultaneously. A generalized linear model was used to find the factors associated with NTG.
Main outcome measures included IOP-related patterns—including mean and standard deviation of measurements—amplitude of cosine-fit curve, acrophase (signal peak) and bathyphase (signal trough) values (mVEq). Here were some of the findings:
- The SD of the 24-hour CLS measurements was significantly greater in NTG eyes (112.51 ±26.90 mVEq) than in healthy controls (85.18 ±29.61 mVEq)(p=0.002).
- The amplitudes of cosine-fit curve (141.88 ±39.96 vs. 106.08 ±41.49 mVEq; p=0.004) and acrophase values (277.74 ±129.80 vs. 190.58 ±127.88 mVEq; p=0.024), measured primarily during the nocturnal period, were significantly greater in NTG eyes than in healthy controls.
- NTG subjects slept longer on their sides than did healthy controls (199.1 ±137.8 vs. 113.2 ±86.2 minutes, p=0.009).
- In the multivariable generalized linear model, the greater amplitude of cosine-fit curve (β=0.218; p=0.012) and greater time on their sides during sleep (β=0.180; p=0.004) were found to be significantly associated with NTG.
Researchers wrote that continuous monitoring of 24-hour IOP-related values with CLS may be useful for assessment of glaucoma risk, especially for NTG patients whose IOP appears to be in the normal range. They added that fluctuation of 24-hour IOP-related values and posture during sleep time might be associated with NTG.
SOURCE: Kim YW, Kim J-S, Lee SY, et al. 24-hour intraocular pressure-related patterns from contact lens sensors in normal-tension glaucoma and healthy eyes: The ENIGMA study. Ophthalmology 2020; May 14. [Epub ahead of print].
Bausch + Lomb Infuse Daily Disposable Silicone Hydrogel CLs Receive FDA 510(k) Approvals
Bausch + Lomb received 510(k) clearance from the FDA for Infuse daily disposable silicone hydrogel (SiHy daily) contact lenses. The lenses feature a next-generation contact lens material (kalifilcon A), designed in particular to aid contact lens wearers experiencing contact lens dryness. Engineered with proprietary technologies, the lenses are intended to provide outstanding breathability for healthy lens wear while providing exceptional all-day comfort and high definition optics, the company says. Learn more.
Lineage Announces Restoration of Retinal Tissue in OpRegen Phase I/IIa Study
Lineage Cell Therapeutics announced that restoration of retinal tissue was observed in a patient enrolled in a Phase I/IIa study of its lead product candidate, OpRegen, a retinal pigment epithelium cell transplant therapy in development for the treatment of dry age-related macular degeneration. Lineage plans to host a live call on June 8 to discuss the findings. Read more.
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