From the editors of Review of Ophthalmology:
Monday, September 30, 2019
SEPTEMBER IS HEALTHY AGING MONTH
In this issue: (click heading to view article)
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Risks for Post-refractive Dry Eye
Researchers determined the factors associated with clinically significant dry eye after keratorefractive surgery, as part of a large database retrospective study that included consecutive cases of myopic laser in situ keratomileusis or photorefractive keratectomy performed between 2008 and 2016 at Care-Vision Laser Center, Israel. Patients were divided into two groups according to whether they developed clinically significant dry eye.
A total of 25,317 right eyes of 25,317 individuals, with a mean age of 27 ±8.3 years, were included. Here were some of the findings:
• Postoperative dry eye developed in 1,518 eyes (6 percent).
• The dry-eye group was older (29.2 ±9 vs. 27.6 ±8.3 years; p<0.001) and had a:
○ higher proportion of women (48.5 vs. 44.8 percent; p=0.005);
○ lower preoperative spherical equivalent (3.7 ±2 vs. 4 ±2.3 D; p<0.001);
○ lower preoperative best-corrected visual acuity (0.019 ±0.057 vs. 0.016 ±0.064 logMAR; p=0.04); and
○ lower proportion of preoperative soft contact lens wearers (40.6 vs. 45.5 percent; p<0.001).>
• In the postoperative dry eye group, a high proportion of individuals underwent LASIK (52.4 vs. 38.7 percent, p<0.001) and was treated with a 7-mm (as opposed to 6-mm) optic zone (18.9 vs. 16.3 percent; p<0.001).
• In multivariable analysis, older age (OR, 1.013; p<0.001), female gender (OR 0.87, p=0.009), lower preoperative refractive error (OR 1.05; p<0.001) and LASIK (OR 0.67; p<0.001) were associated with postoperative dry eye.
Researchers found that individuals who were older, female, had a lower preoperative refractive error and who had undergone LASIK were more likely to develop dry-eye disease after keratorefractive surgery.
Source: Shehadeh-Mashor R, Mimouni M, Shapira Y, et al. Risk factors for dry eye after refractive surgery. Cornea 2019; Epub ahead of print.
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Outcomes of Outpatient Vitrectomy for PDR
Investigators compared postoperative outcomes of 27-ga and 25-ga. vitrectomy conducted as outpatient surgery for proliferative diabetic retinopathy. They analyzed 185 consecutive PDR patients (185 eyes) who underwent primary vitrectomy (27-ga. in 64 eyes, 25-ga. in 121 eyes).
Here were some of the findings:
• The 27- and 25-ga. groups didn’t differ significantly in preoperative Early Treatment Diabetic Retinopathy Study score, age or preoperative intraocular pressure.
• The proportions of simultaneous cataract surgery (27-ga. vs. 25-ga.: 59.4 vs. 62.4 percent) and air-filled eyes (76.6 vs. 85.1 percent) weren’t significantly different between two groups.
• Both groups showed significant improvement in ETDRS scores at postoperative one, three and six months (all, p<0.0001).
• Mean gain in ETDRS score from baseline was apparently better in the 27-ga. group than in 25-ga. group at one, three and six months, but no significant differences were detected (one month: 20.3 vs. 13.1 letters, p=0.0703; three months: 22.9 vs. 17.5 letters, p=0.1561; six months: 24.3 vs. 19.3 letters, p=0.3313).
• Operation time was apparently longer for 27-ga. vitrectomy, but no significant differences were detected (54 vs. 51.1 minutes, p=0.3676).
• The same was observed for postoperative intraocular pressure at postoperative day one (19.7 vs. 18.1 mmHg; p=0.1353).
• Incidence of postoperative retinal detachment (1.6 vs. 0.8 percent) and reoperation due to vitreous hemorrhage (6.3 vs. 6.6 percent) wasn’t different between the two groups.
Investigators concluded that the 27-ga. system was as safe and as useful as the 25-ga. system when used for PDR and could be expected to achieve earlier recovery of postoperative visual acuity.
SOURCE: Naruse Z, Shimada H, Mori R, et al. Surgical outcomes of 27-gauge and 25-gauge vitrectomy day surgery for proliferative diabetic retinopathy.
Int Ophthalmol. 2019 Sep;39:9:1973-80.
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Clinical Outcomes of Different DME Components on OCT
Scientists evaluated the edema reduction after intravitreal injection of ranibizumab in two diabetic macular edema components in the same eye, using optical coherence tomography.
A total of 113 eyes with mixed OCT patterns of DME were included. All eyes underwent best-corrected visual acuity examination and OCT scanning at baseline and follow-up visits (one, three and six months after three monthly consecutive IVR). Scientists classified the mixed OCT pattern of DME into two OCT components: serous retinal detachment (SRD) component and non-SRD component. They compared foveal thickness of the SRD component (SRDFT) and the non-SRD component (NSRDFT) between baseline and follow-up visits. They compared reduction and reduction ratio of the SRDFT and the NSRDFT at each follow-up. In addition, the scientists, when calculating the NSRDFT reduction ratio, optimized a commonly used formula by subtracting the normal foveal thickness from the baseline NSRDFT. Here were some of the findings:
• SRDFT was 265.6 ±175.4 μm at baseline and was significantly decreased to 126.7 ±114.4 μm at one month, to 110.5 ±103.4 μm at three months and to 110.4 ±89.6 μm at six months (all p<0.001).
• NSRDFT was 409.5 ±173.1 μm at baseline and was significantly decreased to 274.1 ±140.4 μm at one month, to 249.1 ±95.9 μm at three months and to 254.1 ±90.4 μm at six months (all p<0.001).
• No significant differences in reduction or reduction ratio were found between NSRDFT and SRDFT during follow-up (all p>0.05).
• The correlation between BCVA and SRDFT was most significant at baseline (r=0.366, p<0.001), and the correlation between BCVA and NSRDFT was most significant at six months (r=0.426; p<0.001).
• BCVA improvement was more significantly correlated with reduction or reduction ratio of SRDFT at each follow-up time point (r=0.271-0.426; all p<0.01).
Scientists reported that the IVR was effective in reducing the SRD and non-SRD components of DME, according to their optimized formula. They added that the association between BCVA improvement and edema reduction was more significant in the SRD component.
SOURCE: Hu Y, Wu Q, Liu B, et al. Comparison of clinical outcomes of different components of diabetic macular edema on optical coherence tomography. Graefes Arch Clin Exp Ophthalmol 2019; Sep 16. [Epub ahead of print].
Anti-VEGF Therapy and Risk of Traction Retinal Detachment in PDR Eyes
Researchers assessed whether anti-vascular endothelial growth factor for diabetic macular edema or proliferative diabetic retinopathy increased the risk of traction retinal detachment (TRD) among eyes with PDR.
They used a pooled analysis of PDR eyes from Protocols I, J, N, S or T with Early Treatment Diabetic Retinopathy Study level ≥61 (prompt vitrectomy wasn’t planned) randomly assigned to the control group (laser photocoagulation, sham or intravitreal saline; 396 eyes) or anti-VEGF (487 eyes). The primary outcome was investigator-identified TRD within one year of randomization. Here were some of the findings:
• The one-year cumulative probability of TRD was 6.8 percent (CI, 4.6 to 9.9 percent; 25 events) in control eyes and 4.8 percent (CI, 3.2 to 7.3 percent; 22 events) in anti-VEGF eyes (HR=0.95 [CI, 0.54 to 1.66; p=0.86]).
• The cumulative probability of vitrectomy for TRD was 4.4 percent (16 events) in control eyes and 2.2 percent (nine events) in anti-VEGF eyes ( p=0.19).
• The percentages with TRD and vitrectomy for TRD were similar within the strata of DR severity.
Researchers determined that the findings didn’t support the hypothesis that anti-VEGF therapy for DME or PDR increased the risk of TRD among eyes with PDR similar to those enrolled in five DRCR Retina Network protocols, in which prompt vitrectomy wasn’t planned.
SOURCE: Bressler N, Beaulieu WT, Bressler SB, et al. Anti-vascular endothelial growth factor therapy and risk of traction retinal detachment in eyes with proliferative diabetic retinopathy. Retina 2019; Sep 17. [Epub ahead of print].
Aldeyra Therapeutics Receives Fast Track Designation for ADX-2191
Aldeyra Therapeutics announced the FDA granted fast track designation to ADX-2191 for the prevention of proliferative vitreoretinopathy. Aldeyra expects to initiate its adaptive Phase III GUARD Trial of ADX-2191 for the prevention of PVR in the fourth quarter of 2019. The trial will compare recurrence rates of PVR-related retinal detachment across individuals treated with ADX-2191 or standard of care following surgical repair of retinal detachment. ADX-2191, an intravitreal formulation of methotrexate, was granted orphan drug designation for the prevention of PVR. Read more.
Genentech-Roche Researchers Develop Deep Learning Model to Predict DR Patient Progression
Genentech-Roche scientists have reportedly developed the first deep learning model that can predict which patients with diabetic retinopathy will progress the fastest based on images of the retina taken at a single doctor visit, according to a paper published in the Sept. 20 online edition of the open-access journal Nature Digital Medicine. With this technology, the companies say, ophthalmologists might better tailor treatment by knowing whether a patient’s condition is likely to progress in one to two years. They add that, for clinical trials, the predictive algorithm could be used to help stratify patients based on speed of progression. Read more.
Prevent Blindness Urges Consumers to Seek Expert Advice, Obtain Rx for all CLs
Prevent Blindness has declared October as Contact Lens Safety Awareness Month to educate the public on the best ways to care for their eyes through safe use and care of contact lenses. In a press release, Prevent Blindness wrote that many consumers might not be aware that the FDA regulates contact lenses and certain contact lens care products as medical devices. Additionally, it added that the FDA states that contact lenses are not over-the-counter devices, so companies that sell them as such are misbranding the device and violating Federal Trade Commission regulations by selling contact lenses without having a valid prescription. Prevent Blindness stressed that any time a foreign object or material is placed in the eye, there’s an increased risk of complications and that all contact lens wearers should follow an eye doctor's instructions about care and cleaning of the lenses. Read more.
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