Review of Ophthalmology Online


Volume 18, Number 42
Monday, October 15, 2018


In this issue: (click heading to view article)
######### Amount of VF Loss Associated With Disability in Glaucoma
######### DRIL & VA Response to Anti-VEGF Therapy for ME Secondary to RVP
######### Long-term IOL Decentration & Tilt in Eyes With PES Post-cataract Surgery
######### Intralesional Macular Atrophy in Anti-VEGF Therapy for AMD in IVAN Trial


Amount of VF Loss Associated With Disability in Glaucoma

Researchers proposed a new methodology for classifying patient-reported outcomes in glaucoma and quantifying the amount of visual field damage associated with disease disability, as part of a cross-sectional study of 263 individuals with glaucoma.

Researchers assessed vision-related disability by the National Eye Institute Visual Function Questionnaire (NEI VFQ-25). They applied a latent class analysis model to analyze NEI VFQ-25 data, and divided individuals into mutually exclusive classes according to their responses to the questionnaires. And they investigated differences in standard automated perimetry mean deviation and integrated binocular mean sensitivity values between classes. The optimal number of classes was defined by fitting criteria, interpretability and clinical utility.

• The model with two classes—disabled and non-disabled—had the best fit with entropy of 0.965, indicating excellent separation of classes.
• A total of 48 (18 percent) individuals were disabled, while 215 (82 percent) were non-disabled.
• The average MD of the better eye was -5.98 dB in the disabled group vs. -2.51 dB in the non-disabled group (p<0.001).
• For the worse eye, corresponding values were -13.36 dB and -6.05 dB, respectively (p<0.001).

Researchers concluded that the LCA model enabled categorization of patient-reported outcomes and quantification of VF levels associated with disability in glaucoma. They added that damage of approximately -6 dB for SAP MD, indicating relatively early VF loss, might be associated with significant disability if occurring in the better eye.

SOURCE: Jammal AA, Ogata NG, Daga FB, et al. What is the amount of visual field loss associated with disability in glaucoma? Am J Ophthalmol 2018; Sep 17. [Epub ahead of print].

DRIL & VA Response to Anti-VEGF Therapy for ME Secondary to RVP

Investigators wrote that disorganization of retinal inner layers (DRIL) has demonstrated significant correlations with visual acuity in center-involved diabetic macular edema. They hypothesized that DRIL might be a useful biomarker in determining VA outcomes in individuals with retinal vein occlusion and secondary macular edema. As such, they examined whether DRIL at baseline and after treatment was associated with VA in RVO.

Investigators conducted a retrospective records review of 147 individuals, 18 years or older, who presented to a tertiary ophthalmic center from Dec. 1, 2010, to Jan. 1, 2016. The patients suffered from treatment-naive branch RVO, central RVO or hemispheric RVO, and had a minimum of 12 months of follow-up. Exclusion criteria included active confounding retinal or ocular disease, history of pars plana vitrectomy or prior intravitreal injections. Two masked graders calculated a DRIL score based on DRIL presence in three predefined regions on spectral-domain optical coherence tomography at baseline, six months and 12 months. A third masked grader was used for discrepancies.

Exposures included anti-vascular endothelial growth factor therapy (ranibizumab, aflibercept or bevacizumab) determined by the treating physician. Main outcomes and measures included DRIL scores at baseline to determine VA outcomes and correlation with changes in DRIL burden as a result of AVF therapy.

• In the 147 participants (mean [SD] age, 68.9 [13.1] years; 75 [51 percent] female), baseline DRIL was seen in 91 eyes (61.9 percent).
• In the BRVO group, baseline DRIL was associated with lower baseline Early Treatment Diabetic Retinopathy Study score (score of 66.7 for no DRIL vs. 54.6 for DRIL; p=0.002).
• Absence of DRIL at baseline in the CRVO/HRVO group correlated with greater VA gains at six months, adjusting for baseline VA (score change of 19.50 for no DRIL vs. 12.72 for DRIL; p=0.04).
• During 12 months, DRIL presence in BRVO was associated with less VA gain up to six months (score change of 6.2 for the increase group vs. 18.6 for the decrease group and 2.9 for the stable group; p=0.02).
• Increased DRIL scores in CRVO/HRVO were associated with reduced VA improvement at six months (score change: -0.12 for the increase group vs. 16.90 for the decrease group and 8.45 for the stable group; p=0.002) and 12 months (score change: -1.91 for the increase group vs. 17.83 for the decrease group and 6.97 for the stable group; p<0.001).

Investigators wrote that baseline DRIL presence and burden change with AVF therapy for macular edema secondary to RVO might be useful biomarkers of ETDRS score improvements.

SOURCE: Babiuch AS, Han M, Conti FF, et al. Association of disorganization of retinal inner layers with visual acuity response to anti-vascular endothelial growth factor therapy for macular edema secondary to retinal vein occlusion. JAMA Ophthalmol 2018; Oct 4. [Epub ahead of print].

Long-term IOL Decentration & Tilt in Eyes With PES After Cataract Surgery

Scientists evaluated long-term intraocular lens decentration and tilt in eyes with pseudoexfoliation syndrome following cataract surgery using Visante Omni anterior segment optical coherence tomography (Carl Zeiss; Jena, Germany) and the iTrace Visual Function Analyzer (Hoya Surgical Optics, Singapore).

Sixty-four post-cataract surgery (from 2009 to 2012) eyes were included—34 had PES and 30 didn’t show PES. A standard phacoemulsification procedure followed by IOL implantation was performed, and individuals were followed from four to six years after surgery (mean=69 months). Scientists measured best-corrected visual acuity, capsulorhexis size and intraocular pressure. They evaluated IOL decentration and tilt and measured corneal, internal and total optical aberrations. Measurements showed the following:

• Horizontal coma was significantly different between PES and control eyes (p=0.037).
• Horizontal and vertical tilt were significantly different between PES and control eyes (p=0.035 and p=0.039).
• Tilt correlated with capsulorhexis size in individuals with PES (p=0.011), indicating a forward tilt of the IOL superior edge in PES eyes.

Scientists suggested that individuals affected by PES appeared to have a higher risk for long-term complications and changes in visual perception due to IOL tilt and decentration after cataract surgery.

SOURCE: Burgmüller M, Mihaltz K, Schütze C, et al. Assessment of long-term intraocular lens (IOL) decentration and tilt in eyes with pseudoexfoliation syndrome (PES) following cataract surgery. Graefes Arch Clin Exp Ophthalmol 2018; Oct 1. [Epub ahead of print].

Intralesional Macular Atrophy in Anti-VEGF Therapy for AMD in IVAN Trial

Researchers reported on the development and progression of macular atrophy and its relationship with morphologic and functional measures in the Inhibition of Vascular endothelial growth factor in Age-related choroidal Neovascularisation (IVAN) trial. They performed a reading center analysis of data from a randomized controlled trial.

Participants included individuals with previously untreated neovascular age-related macular degeneration. Color, fluorescein angiography and OCT images acquired at baseline and during two-year follow-up were graded systematically for MA presence. Researchers used regression models to assess relationships between MA and lesion morphology, and vision measures (best-corrected distance and near acuity, reading speed and index, and contrast sensitivity).

The primary outcome was development of intralesional MA (≥175 μm as greatest linear dimension of choroidal vessels seen on FA and/or color with OCT) within the maximum footprint of the neovascular lesion.

• In 594 participants, 57 individuals (9.6 percent) showed intralesional MA at baseline.
• Incident intralesional MA occurred in 24.4 percent of individuals, and extralesional MA occurred in 1.54 percent by the final visit.
• A total of 248 fellow eyes had an established nAMD lesion at baseline, of whom 42 (16.9 percent) showed intralesional MA at baseline and 32 (12.9 percent) developed incident intralesional MA.
• The odds of incident intralesional MA by the final visit were lower in eyes that had ≥50 percent classic CNV at baseline (OR, 0.39; CI, 0.19 to 0.80; p=0.010), subretinal fluid at final visit (OR, 0.41; CI, 0.25 to 0.76; p=0.004) or pigment epithelial detachment at final visit (OR, 0.40; CI, 0.21 to 0.74; p=0.004).
• Secondary analyses of incident or progressed intralesional MA supported the initial findings, with odds increasing if the fellow eye had baseline intralesional MA (OR, 2.43; CI, 1.09 to 5.44; p=0.030).
• No significant associations were observed between development of intralesional MA and other morphologic or visual function measures.

Researchers determined that macular atrophy frequently developed within nAMD lesions in eyes receiving anti-VEGF therapy over two years. They detected no associations between incident MA and drug or treatment frequency, or visual function; however, they added that longer-term effects remained unknown.

SOURCE: Bailey C, Scott LJ, Rogers CA, et al. Intralesional macular atrophy in anti–vascular endothelial growth factor therapy for age-related macular degeneration in the IVAN Trial. Ophthalmology 2018; Oct 6. [Epub ahead of print].

  • Konan Medical Gets FDA 510(k) Nod for objectiveField Perimeter
    The objectiveField is a novel, U.S. FDA-cleared device designed to assess the human visual field in an objective and non-contact manner, without need for manual patient input, says Konan Medical. Using a patented multifocal pupil objective perimetry method (mfPOP), the perimeter tests both eyes simultaneously in a few minutes. Clinically researched in Australia for more than 12 years with more than 16,000 exams across glaucoma, macular degeneration, diabetic retinopathy and other neuro-visual conditions, objectiveField was acquired from the Australian National University and includes novel features licensed from Seeing Machines. The technology will debut at the American Academy of Ophthalmology Annual Meeting in Chicago, Oct. 26 to 30, at the Konan Medical Booth (#2515), and showcased at the American Academy of Optometry in San Antonio, Nov. 7 to 9. Read more.

  • Oculus Releases Smartfield Perimeter
    Oculus released the Smartfield perimeter, optimized for exams for functional impairment of the central visual field and suited for peripheral measurements. The Smartfield performs standard automated perimetry using an ultra-high luminance LCD display. Its short measurement times make it well-suited for standard screening methods. In addition, the software offers a wide array of measurement procedures for diagnostic and follow-up exams. The perimeter requires little set-up space and can be operated in rooms with normal lighting conditions. A translucent lateral eye shield eliminates the need for an eye patch, saving time to prepare for the exam, Oculus says. Learn more.

  • Novartis Transfers Several Existing Drugs Back to Alcon
    Alcon received a portfolio of time-tested mydriatic, cycloplegic, diagnostic and anesthetic products from parent company Novartis. The familiar products offered in the portfolio include:
    • Isopto Atropine (atropine sulfate ophthalmic solution) 1%, indicated for mydriasis, cycloplegia and penalization of the healthy eye in the treatment of amblyopia;
    • Cyclogyl (cyclopentolate hydrochloride ophthalmic solution, USP), an anticholinergic used to produce mydriasis and cycloplegia;
    • Mydriacyl (tropicamide ophthalmic solution, USP), an anticholinergic indicated for mydriasis and cycloplegia for diagnostic procedures;
    • Cyclomydril (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution), indicated for the production of mydriasis;
    • Fluorescite (fluorescein injection, USP) 10%, indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature;
    • Tetracaine Hydrochloride Ophthalmic Solution 0.5% steri-unit, an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. Learn more.

  • EMA to Begin MAA for Rhokiinsa (Netarsudil Ophthalmic Solution) 0.02%,
    Aerie Pharmaceuticals reported that the European Medicines Agency accepted for review the Marketing Authorisation Application for Rhokiinsa (netarsudil ophthalmic solution) 0.02%. Rhokiinsa, marketed as Rhopressa in the United States, is indicated for the reduction of elevated intraocular pressure in individuals with open-angle glaucoma or ocular hypertension. Read more.

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