From the editors of Review of Ophthalmology:
JUNE IS FIREWORKS EYE SAFETY & CATARACT AWARENESS MONTH
In this issue: (click heading to view article)
The Impact of Graft Shift Direction After DMEK
Researchers evaluated the effects of graft shift orientation on clinical outcomes after Descemet’s membrane endothelial keratoplasty. They used intraoperative video images to retrospectively examine the effect of graft shift direction in 50 eyes of 50 individuals. Researchers assessed correlations between graft shift direction and multiple parameters. Here were some of the findings:
• The graft detachment rate was higher in eyes with an inferior graft shift than in those without (superior: 0 percent for graft shift-negative cases and 5 percent for graft shift-positive cases; nasal: 0 percent for graft shift-negative cases and 20 percent for graft shift-positive cases; inferior: 16.7 percent for graft shift-negative cases and 55 percent for graft shift-positive cases; temporal: 16.7 percent for graft shift-negative cases and 45 percent graft shift-positive cases; and any segment: 23.3 percent for graft shift-negative cases and 65 percent for graft shift-positive cases).
• Postoperative endothelial cell density reduction was higher in eyes with an inferior graft shift (one month: 23.6 percent ±13.7 percent for graft shift-negative cases and 37.5 percent ±18.8 percent for graft shift-positive cases; three months: 31.6 percent ±16.4 percent for graft shift-negative cases and 45.2 percent ±15.2 percent for graft shift-positive cases; and six months: 39.8 percent ±14.9 percent for graft shift-negative cases and 50.7 percent ±16.6 percent for graft shift-positive cases.
• Eyes with a superior graft shift had lower postoperative endothelial cell density reduction than those without (one month: 36.9 percent ±16.6 percent for graft shift-negative and 20 percent ±13.1 percent for graft shift-positive cases; three months: 45.3 percent ±13.3 percent for graft shift-negative cases and 27.4 percent ±16.2 percent for graft shift-positive cases; and six months: 51.3 percent ±14.6 percent for graft shift-negative cases and 35.9 percent ±14.5 percent for graft shift-positive cases).
• Graft shift direction didn’t affect postoperative best-corrected visual acuity or central corneal thickness.
Researchers determined that graft shift direction in DMEK, especially inferior graft shift, affected the postoperative graft detachment rate and that superior graft shift had a beneficial effect on postoperative corneal endothelial values. They added that their findings suggested that inferior graft shift should be avoided in DMEK.
SOURCE: Yuda K, Kato N, Takahashi H, et al. Effect of graft shift direction on graft detachment and endothelial cell survival after Descemet membrane endothelial keratoplasty. Cornea 2019; May 23. [Epub ahead of print].
Intravitreal Ranibizumab vs. Aflibercept Following Treat-and-extend Protocol for nAMD
Investigators assessed the morphological and functional outcome and stability of the treat-and-extend protocol using aflibercept compared with ranibizumab for the treatment of eyes with neovascular age-related macular degeneration.
The retrospective study included 100 eyes of 94 individuals with primary onset neovascular age-related macular degeneration, followed up for 12 months. Investigators studied two groups of eyes: group one: 50 eyes treated with 0.5 mg/0.05 mL ranibizumab; and group two, 50 eyes treated with 2 mg/0.05 mL aflibercept. During the first year, all eyes received three aflibercept or ranibizumab injections monthly as the upload phase. Then eyes were treated with a treat-and-extend algorithm.
The main outcome measures included best-corrected visual acuity, central macular thickness and the number of injections. In addition, investigators compared recurrence rates between the two groups. Here were some of the findings:
• BCVA (log MAR) was 0.54 ±0.31 in group one vs. 0.49 ±0.30 in group two (p=0.38) before treatment and 0.49 ±0.33 in group one vs. 0.47 ±0.32 in group two (p=0.85) after treatment.
• The visual improvement (decimal) was 0.05 ±0.13 in group one vs. 0.04 ±0.12 in group two (p=0.91).
• The CMT was 375.6 ±98.3 μm in group one vs. 369.6 ±103.7 μm in group two (p=0.73) before treatment and 306.3 ±71.8 μm in group one vs. 294.8 ± 96 μm in group two (p=0.54) after treatment.
• The decrease in CMT was 69.3 ±93 μm in group one vs. 74.8 ±96 μm in group two (p=0.77).
• The number of injections/eye after upload phase was 5.88 ±1.4 in group one vs. 6.16 ±1.3 in group two (p=0.25).
• Finally, major recurrence rates were statistically significantly different between group one (2 percent) vs. group two (6 percent)(p=0.04).
Investigators concluded that significant differences regarding BCVA, CMT and number of injections weren’t found between aflibercept and ranibizumab during the first year following the treat-and-extend protocol. However, they wrote that the significantly higher major recurrence rates in the aflibercept group after extending the treatment interval to 10 weeks might indicate that aflibercept shouldn’t be used in longer than eight-week intervals during the first year of treatment.
SOURCE: Abdin AD, Suffo S, Asi F, et al. Intravitreal ranibizumab versus aflibercept following treat and extend protocol for neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol 2019; May 29. [Epub ahead of print].
Corneal Biomechanical Changes After Trabeculectomy with Mitomycin C
Scientists aimed to examine the effects of trabeculectomy with mitomycin C on corneal biomechanical characteristics in PEXG and POAG patients, as part of a prospective, comparative case series study,
A total of 32 glaucoma patients, of whom 17 had PEXG and 15 had POAG, were enrolled. All individuals underwent complete ocular exams, had central corneal thickness measured using ultrasound pachymetry and took part in corneal biomechanical studies with the Ocular Response Analyzer (Reichert). The patients were hospitalized, and trabeculectomy surgery with mitomycin was done. Three months after surgery, patients were examined and ORA was obtained again. Here were some of the findings:
• The mean CH in PEXG patients (5.66 ±1.13) was statistically significantly lower than in POAG patients (7.49 ± 0.88) before surgery (p<0.001).
• CRF in PEXG patients (8.19 ±1.48) was statistically significantly lower than in POAG patients (9.35 ± 1.60) before surgery (p=0.049).
• CH increased and reached 6.69 ±0.78 (p<0.001) in the PEXG group after TBX + MMC surgery.
• CH increased in the POAG group after TBX + MIC surgery and reached 8.23 ±1.09, which was statistically significant (p=0.001).
• Scientists found a statistically significant relationship between CH and IOP changes in the PEXG group (p<0.001) and POAG group (p=0.01).
• Although TBX + MMC surgery changed the amount of CH in PEXG and POAG groups, no significant difference was shown in the parameters between the two groups comparing the CH changes (p=0.33).
Scientists reported that the biomechanical characteristics of the cornea, particularly corneal hysteresis, showed certain changes following surgery and increased, reflecting the dynamic nature of these parameters. They wrote that a better understanding of biomechanical changes after glaucoma surgery could offer clinicians a more complete picture of the pathophysiology of glaucoma to assist them in making the right decisions for patient follow-up.
SOURCE: Sorkhabi R, Najafzadeh F, Sadeghi A, et al. Corneal biomechanical changes after trabeculectomy with mitomycin C in primary open-angle glaucoma and pseudoexfoliation glaucoma. Int Ophthalmol 2019; May 27. [Epub ahead of print].
OCT Risk Factors for Development of Late AMD in Fellow Eyes in HARBOR
Researchers analyzed the relationship between optical coherence tomography features and the progression to late age-related macular degeneration in the fellow eyes of individuals enrolled in the 24-month HARBOR study for neovascular AMD.
This post hoc analysis of a Phase III multicenter, prospective, randomized, double-masked, active treatment-controlled clinical trial included subjects (n=501) with macular neovascularization secondary to neovascular AMD, and early or intermediate AMD in the fellow eye.
Researchers reviewed volume OCT scans from 501 fellow eyes of 501 individuals with MNV. They assessed baseline OCT features, including intraretinal hypereflective foci (IHRF), hyporeflective foci (hRF) within drusenoid lesions (DLs), subretinal drusenoid deposits (SDD) and drusen volume (DV) ≥0.03 mm3. Masked graders graded OCT images at months six, 12, 18 and 24 for late AMD (defined as MNV and/or complete retinal pigment epithelium and photoreceptor atrophy [cRORA]). Researchers correlated subject demographic characteristics (age, gender, smoke exposure) and baseline OCT features with progression to late AMD. Main outcome measures included incidence of late AMD, hazard ratio for demographics and OCT risk factors. Here were some of the findings:
• At month 24, 33.13 percent (166/501) eyes developed late AMD, 20.96 percent (105/501) developed cRORA while 12.18 percent (61/501) developed MNV.
• Baseline demographic factors weren’t significantly associated with development of late AMD, while significant associations were identified for all OCT features.
• IHRF had an HR of 5.21 (CI, 3.29 to 8.26); hRF within DLs had an HR of 2.42 (CI, 1.74 to 3.38); SDDs had an HR of 1.95 (CI, 1.34 to 2.82); and DV ≥0.03 mm3 had an HR of 1.46 (CI, 1.03 to 2.07). The correlation remained statistically significant when considering progression to cRORA and MNV alone; however, DV wasn’t significantly associated with progression to MNV.
Researchers confirmed that four previously reported OCT risk factors were associated with progression to late AMD in the fellow eyes of subjects newly diagnosed with MNV. They added that, although outcomes after two years weren’t evaluated, the findings might help identify high-risk AMD patients.
Source: Nassisi M, Lei J, Abdelfattah NS, et al. Optical coherence tomography risk factors for development of late age related macular degeneration in the fellow eyes of patients enrolled in the HARBOR Study. Ophthalmology 2019; May 28. [Epub ahead of print].
Allegro Phase II Study Evaluating Risuteganib Meets Primary Endpoint
Allegro Ophthalmics announced that its prospective, double-masked, placebo-controlled Phase II study of risuteganib (Luminate) for the treatment of intermediate non-exudative age-related macular degeneration met its primary endpoint, with 48 percent of patients in the risuteganib arm (two injections) gaining ≥8 letters of vision at week 28 compared with baseline (one sham treatment). Read more.
Re-Vana Names Experts to Inaugural Scientific Advisory Board
Re-Vana Therapeutics, a developer of photo-crosslinked drug delivery technologies for large and small molecules, announced the formation of a new scientific advisory board. The SAB includes: Clive Wilson, PhD, Re-Vana’s chief scientific officer and research professor at Strathclyde University in Glasgow, Scotland, serving as head of the SAB; David Guyer, MD, Re-Vana cofounder, and former CEO and executive chairman of Ophthotech’s board; and David Jones, PhD, DSc, FREng, Re-Vana cofounder and professor of biomaterial science at Queen’s University Belfast. Read more.
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