Review of Ophthalmology Online

Volume 14, Number 15
Monday, April 9, 2018


In this issue: (click heading to view article)
######### Impact of Same-session Trabectome on Ahmed Glaucoma Valve Outcomes
######### Extended Field Imaging Using SS-OCTA for RVO
######### Conventional Trabeculectomy vs. Trabeculectomy with Ex-Press Mini-Shunt
######### Loss to Follow-up in PDR Cases after Panretinal Photocoagulation or Intravitreal Anti-VEGF Injections


Impact of Same-session Trabectome on Ahmed Glaucoma Valve Outcomes

Researchers evaluated the efficacy and survival rates of same-session ab interno trabeculectomy with the Trabectome and Ahmed glaucoma valve implant compared with the Ahmed glaucoma valve alone. One of the authors has received honoraria from the Trabectome’s maker, NeoMedix.

A total of 107 eyes undergoing primary glaucoma surgery were enrolled in the retrospective, comparative case series, including 48 eyes that underwent the same-session implant and 59 eyes that received the valve alone. Researchers identified participants using procedural terminology codes, and reviewed medical records. The primary outcome measures were IOP >5 mm Hg and ≤21 mm Hg, and ≥20 percent IOP reduction from baseline at two consecutive visits after three months, with no need for glaucoma reoperation. Secondary outcome measures were IOP, the number of glaucoma medications, incidence of a hypertensive phase and best-corrected visual acuity.

The cumulative probability of success at one year was 70 percent in the same-session implant group, and 65 percent in the valve-only group (p=0.85). IOP decreased significantly from 26.6 ±10.1 mmHg at baseline to 14.7 ±3.3 mmHg at the final follow-up in the same-session implant group (p=0.001). For the valve-alone group, IOP at baseline was 27.8 ±10.2 mmHg and at final follow-up was 16.7 ±4.9 mmHg (p=0.001). The final IOP was significantly lower in the same-session implant group (p=0.022). The number of medications at baseline was comparable in both groups (2.6 ±1.2 in the same-session implant group and 2.5 ±1.3 in the valve-alone group, p=0.851). At the one-year visit, IOP was 1.2 ±2 mmHg in the same-session implant group and 2.8 ±1.8 mmHg in the valve-alone group (p=0.001). The incidence of a hypertensive phase was 18.7 percent in the same-session implant group and 35.5 percent in the valve-alone group (p=0.05). The hypertensive phase resolved in only 30 percent of eyes. The criteria for hypertensive phase resolution was fulfilled in nine eyes (30 percent). Researchers found no difference in the resolution rate of the hypertensive phase between the same-session implant group (33.3 percent) and valve-alone group (28.5 percent) (p=0.67).

Researchers found that the Ahmed glaucoma valve implant with same-session Trabectome surgery significantly decreased the rate of the hypertensive phase and postoperative IOP, as well as the number of glaucoma medications.

SOURCE: Esfandiari H, Shazly T, Shah P, et al. Impact of same-session trabectome surgery on Ahmed glaucoma valve outcomes. Graefes Arch Clin Exp Ophthalmol 2018; Mar 30. [Epub ahead of print].

Extended-field Imaging Using SS-OCTA for RVO

Investigators analyzed the degree of ischemia in eyes with retinal vein occlusion using swept-source optical coherence tomography angiography with the extended-field imaging technique, which extends the area encompassed by SS-OCTA by scanning through trial frames fitted with a +20-D lens.

The retrospective, observational study included 23 consecutive eyes of 22 individuals with RVO who underwent 12 × 12 mm SS-OCTA imaging with and without EFI for determination of extension rate. Two graders blinded to the clinical data evaluated the degree of retinal ischemia in paired EFI-SS-OCTA and fluorescein angiography images, and researchers statistically examined the concordance rates between the grades.

One EFI-SS-OCTA image wasn’t successfully obtained due to motion artifacts caused by the individual’s poor central vision, while SS-OCTA images without EFI were captured in all 23 eyes. The average scanning area was enlarged by 76.4 percent. Two graders evaluated the degree of retinal ischemia by measuring nonperfusion areas as the sum of disc areas/diameters. Although their assessments of the EFI-SS-OCTA images were in complete agreement (Cohen’s Unweighted Kappa coefficient=1), concordance using FA images was only moderate (Cohen’s Unweighted Kappa coefficient=0.60).

Investigators determined that EFI-SS-OCTA noninvasively produced wider-field images of retinal vasculature with one capture and provided resolution sufficient to accurately evaluate retinal capillary nonperfusion in RVO.


SOURCE: Kakihara S, Hirano T, Iesato Y. Extended field imaging using swept-source optical coherence tomography angiography in retinal vein occlusion Jpn J Ophthalmol 2018; Mar 28. [Epub ahead of print].

Conventional Trabeculectomy vs. Trabeculectomy with Ex-Press Mini-Shunt

Scientists compared postoperative interventions and outcomes between conventional trabeculectomy and trabeculectomy with the Ex-Press mini-glaucoma shunt device, as part of a retrospective, comparative, single-facility study.

They analyzed the cases of 108 individuals with glaucoma who underwent trabeculectomy and were followed for more than a year. Thirty-nine eyes underwent a conventional trabeculectomy (conventional group), and 69 eyes underwent a trabeculectomy with an Ex-Press. Scientists examined postoperative intraocular pressure, the surgical success rate, postoperative complications, the number of days to laser suture lysis and needling.

The trabeculectomy significantly decreased IOP values from 27.8±7.9 to 11.1±3.9 mmHg in the conventional group (p<0.001) and from 27.7±9.2 to 11.5±3.7 mmHg in the Ex-Press group (p<0.001) after one year. The success rate wasn’t significantly different between groups. The timing of the first laser suture lysis was significantly sooner in the Ex-Press group, and the Ex-Press group showed significantly less choroidal detachment due to low IOP.

Scientists concluded that, in individuals whose trabeculectomy treatment included an Ex-Press, earlier laser suture lysis was required to obtain the outcomes comparable to those of conventional trabeculectomy.

Source: Tojo N, Otsuka M, Hayashi A, et al. Conventional trabeculectomy versus trabeculectomy with the Ex-PRESS mini-glaucoma shunt: Differences in postoperative interventions. Clin Ophthalmol 2018;12:643-50.

Loss to Follow-up in PDR Cases

Researchers wrote that loss to follow-up may contribute to vision loss in individuals with active proliferative diabetic retinopathy. They aimed to determine and compare the rates of LTFU in individuals with PDR receiving panretinal photocoagulation or intravitreal injections with anti-vascular endothelial growth factor over approximately four years. They also assessed various risk factors for LTFU.

The retrospective cohort study included a total of 2,302 individuals with PDR receiving IVIs with anti-VEGF or PRP between January 1, 2012, and April 20, 2016.

Researchers measured intervals between each procedure and the subsequent follow-up visit. They defined loss to follow-up as at least one interval exceeding 12 months duration. Main outcome measures included LTFU rates and associated risk factors.

• A total of 1,718 individuals (74.6 percent) followed up post-procedure and 584 individuals (25.4 percent) were LTFU over approximately four years.
• Of those receiving PRP, 28 percent were LTFU compared with 22.1 percent of individuals receiving IVI with anti-VEGF (p=0.001).
• LTFU rates decreased as age increased, with rates of 28.1 percent for individuals ages ≤55 years, 27 percent for individuals ages 56 to 65 years, and 20.9 percent for individuals ages >65 years (p=0.002).
• Loss to follow-up also differed by race, with rates of: 19.4 percent for whites; 30.2 percent for African Americans; 19.7 percent for Asians; 38 percent for Hispanics, Native Americans and Pacific Islanders; and 34.9 percent for individuals of unreported race (p<0.001).
• LTFU rates also increased as regional average adjusted gross incomes decreased, with rates of 33.9 percent for individuals with regional average AGI of ≤$40 000, 24 percent for individuals with regional average AGI from $41,000 to $80,000, and 19.7 percent for those with regional average AGI >$80,000 (p<0.001).
• Procedure type, age, race and regional average AGI were all significant (p<0.05) independent risk factors of LTFU in the multivariate regression.

Researchers wrote that a large proportion of individuals with PDR were LTFU after receiving PRP or an anti-VEGF injection over approximately four years. They added that key risk factors included age, race and regional average AGI.

SOURCE: Obeid A, Gao X, Ali FS, et al. Loss to follow-up in patients with proliferative diabetic retinopathy after panretinal photocoagulation or intravitreal anti-vegf injections. Ophthalmology 2018; Mar 29. [Epub ehead of print].

  • GenSight Fails to Meet Primary Endpoint in REVERSE Phase III Trial of GS010
    GenSight Biologics announced positive topline results from the REVERSE Phase III clinical trial evaluating the safety and efficacy of a single intravitreal injection of GS010 (rAAV2/2-ND4) in 37 subjects whose visual loss due to 11778-ND4 Leber’s Hereditary Optic Neuropathy commenced between six and 12 months prior to study treatment; however, the trial didn’t meet its primary endpoint. The findings highlighted the favorable safety and tolerability profile of GS010, and demonstrated a clinically meaningful improvement of +11 ETDRS letters (-0.218 LogMAR) in treated eyes at 48 weeks compared with baseline in all 37 individuals. Unexpectedly, untreated contralateral eyes (receiving a sham injection) showed a similar improvement of +11 ETDRS letters (-0.211 LogMAR) so the trial didn’t meet its primary endpoint, defined as a difference of improvement in visual acuity in GS010-treated eyes compared with sham-treated eyes at 48 weeks. Read more.

  • J&J Vision to Highlight New Data, Educational Resources at ASCRS/ASOA Meeting
    Johnson & Johnson Vision will highlight new data at the 2018 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting in Washington, D.C. (April 13-17) that the company says validates the benefits of products such as the Tecnis Symfony and Tecnis Multifocal intraocular lenses, Catalys Precision Laser System and the iDesign System. The company says it will also offer a series of educational opportunities and is sponsoring charitable giving initiatives. A couple examples of some of the data to be presented include:
    • Bucci F. Multivariate regression analysis of patient satisfaction in patients receiving bilateral +3.25 vs bilateral +4.00 diffractive multifocal implants. Poster: On demand in the poster pavilion and on
    • Vardhan P, Goel S, Sharma A. Visual outcomes and real-life performance after bilateral implantation of an extended-vision IOL. Paper Presentation: April 14, 3:17-3:22 p.m., Level 1, 143A.
    Read more.

  • OWL to Host Signature Event & Networking Program at ASCRS/ASOA
    OWL: Advancing Diversity in Leadership says all are welcome to attend the event being held April 13 from 5:30 to 7 p.m. at the Arnold & Porter Offices (601 Massachusetts Avenue NW, Washington D.C.) a few blocks from the Convention Center during the 2018 ASCRS/ASOA meeting. The reception will kick off at 5:30 pm with cocktails and appetizers, followed by a panel discussion. The evening will focus on Leadership in Healthcare: How to Thrive in a Dynamic Market. The panel includes:
    • Moderator: Beth Marsh, Sr. Director Global Commercial Lead, Global Product Strategy, Ophthalmics, Shire
    • Jeffrey J. Kimbell, President, Jeffrey J. Kimbell & Associates
    • Jim Mazzo, Global President Ophthalmic Devices, Carl Zeiss Meditec & Executive Committee Board Member with MDMA
    • Ahmet Tezel, PhD, Surgical Franchise Head, R&D, Alcon, a Novartis Company
    • Ruth Williams, MD, Past President, AAO
    The OWL Signature Event is underwritten by premier sponsor Alcon. Read more.

  • Avedro Celebrates 10-year Anniversary
    Avedro is celebrating 10 years of research, innovation and business. Since its founding in 2008, Avedro says it’s grown from a small R&D company to an internationally recognized ophthalmic pharmaceutical and medical device company, and a leader in corneal remodeling. Important accomplishments Avedro highlights are the introductions of therapies for individuals with progressive keratoconus, including: Photrexa Viscous, Photrexa and the KXL System epi-off corneal cross-linking treatment. Read more.

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