EU Regulators recommend Omidria for use in Lens Replacement Surgery
The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended the approval of marketing authorization for Omidria (phenylephrine and ketorolac injection 1%/3%; Omeros), intended for maintenance of intraoperative mydriasis, prevention of intraoperative miosis, and reduction of acute postoperative ocular pain in lens replacement surgery, according to a news release from the EMA.
The active substances of Omidria are phenylephrine and ketorolac. Phenylephrine is an α-1-adrenergic receptor agonist and acts by contracting the radial muscle of the iris, dilating the pupil and preventing miosis during surgery. Ketorolac is an NSAID that inhibits the enzymes cyclooxygenase COX1 and COX2 and reduces production of prostaglandins, thus reducing inflammation and pain. Omidria will be available as a concentrate for solution for intraocular irrigation (12.37 mg/mL + 4.24 mg/mL).
The most common side effects of Omidria are eye pain and anterior chamber inflammation, the EMA news release said.
The recommendation will now go to the European Commission for final approval. In the United States, Omidria was approved by the FDA in June 2014.
PEEK Smartphone-Based System May be Comparable to Traditional Charts for Visual Acuity Testing
The Portable Eye Examination Kit (PEEK), a smartphone-based system for comprehensive eye testing, was shown to work as well as traditional charts for visual acuity, according to a study published in JAMA Ophthalmology.1
PEEK was designed and developed at the London School of Hygiene & Tropical Medicine, the University of Strathclyde, and the NHS Glasgow Centre for Ophthalmic Research. Founder and first study author Andrew Bastawrous, MRCOphth, was struggling to transport bulky eye equipment in remote areas of Kenya during a 6-year follow-up of the Nakuru Eye Disease Cohort when he decided to try to create a phone-based testing system, according to a news release from the London School of Hygiene & Tropical Medicine.
“With most of the world’s blind people living in low-income countries, it is vital we develop new tools to increase early detection and appropriate referral for treatment,” Dr. Bastawrous said in a news release. “Mobile phone use is now so widespread that it seemed to be an ideal platform.” The PEEK system is not dependent on familiarity with symbols or letters commonly used in the English language.
The study, conducted from December 2013 to March 2014 and nested within the 6-year follow-up of the Nakuru Eye Disease Cohort, included 300 adults aged 55 years and older. The investigators compared results from smartphone-based PEEK acuity to Snellen acuity charts (clinical normal) and the Early Treatment of Diabetic Retinopathy Study (ETDRS) logMAR chart (reference standard). Outcome measures were monocular logMAR visual acuity scores for each test: ETDRS chart logMAR, Snellen acuity, and PEEK acuity. PEEK acuity was compared, in terms of test-retest variability and measurement time, with the Snellen acuity and ETDRS logMAR charts in participants’ homes and temporary clinic settings in rural Kenya in 2013 and 2014.
The investigators found that the 95% CI limits for test-retest variability of smartphone acuity data were ±0.033 logMAR. The mean differences between the smartphone-based test and the ETDRS chart and between the smartphone-based test and Snellen acuity data were 0.07 (95% CI, 0.05–0.09) and 0.08 (95% CI, 0.06–0.10) logMAR, respectively, indicating that smartphone-based test acuities agreed with those of the ETDRS and Snellen charts. The agreement of PEEK acuity with the ETDRS chart was greater than the Snellen chart with the ETDRS chart (95% CI, 0.05–0.10; P=.08). The local Kenyan community health care workers readily accepted the PEEK acuity smartphone test, as it required minimal training and took no longer than the Snellen test (77 seconds vs 82 seconds; 95% CI, 71–84 seconds vs 73–91 seconds, respectively; P=.13).
The study authors concluded that the PEEK acuity smartphone test is capable of accurate and repeatable acuity measurements consistent with published data on the test-retest variability of acuities measured using 5-letter-per-line retroilluminated logMAR charts.
“We aimed to develop and validate a smartphone-based visual acuity test for eyesight that would work in challenging circumstances, such as rural Africa, but also provide reliable enough results to use in routine clinical practice in well-established health care systems,” Dr. Bastawrous said in the news release. “Our ultimate hope is that the accuracy and easy-to-use features of PEEK will lead to more people receiving timely and appropriate treatment and [being] given the chance to see clearly again.”
Although the researchers acknowledged this study involved only Kenyan adults aged 55 and above, they are conducting other studies to determine the suitability of the tool in different contexts across a range of different handsets and operating systems, including a trial involving teachers testing more than 20,000 schoolchildren, the news release said.
1. Bastawrous A, Rono HK, Livingstone I, et al. Development and validation of a smartphone-based visual acuity test (Peek Acuity) for clinical practice and community-based fieldwork [published online ahead of print May 28, 2015]. JAMA Ophthalmol. doi:10.1001/jamaophthalmol.2015.1468.
Use of Two OVDs During Intumescent Cataract Surgery Reduced Intraoperative Complications
Using both medium- and high-viscosity OVDs led to safe indentation of the anterior lens capsule and reduced the risk for enlargement of the continuous curvilinear capsulorrhexis (CCC) and capsular tear during cataract surgery, according to a study published in the Journal of Cataract & Refractive Surgery.1
After staining the capsule with trypan blue, the surgeons created a central indentation of the anterior lens capsule using a medium-viscosity OVD (Healon 1%; Abbott Medical Optics) in group 1 (n=21 eyes) and both medium- and high-viscosity (Healon 2.3%; Abbott Medical Optics) OVDs in group 2 (n=20 eyes). They placed the high-viscosity OVD centrally. Next, they created the CCC and recorded the horizontal and vertical diameters of the CCC, the deviation from the target diameter, and recorded intraoperative complications.
According to the study authors, deviation from the target CCC diameter occurred in 12 eyes (10 oversized, 2 undersized) in group 1 and six eyes (4 oversized, 2 undersized) in group 2. Capsular tears occurred in two eyes in group 1 and none in group 2. The procedure had to be converted to extracapsular cataract extraction with anterior vitrectomy for one eye in group 1.
1. Hengerer FH, Dick HB, Kohnen T, Conrad-Hengerer I. Assessment of intraoperative complications in intumescent cataract surgery using 2 ophthalmic viscosurgical devices and trypan blue staining. J Cataract Refract Surg. 2015;41(4):714-718.
Phantom Eye Syndrome Frequently Experienced After Enucleation for Uveal Melanoma
About half of patients who underwent enucleation for uveal melanoma experienced phantom eye syndrome (PES), according to a study published in Ophthalmology.1
Laura Hope-Stone, MSc, CPsychol, of the University of Liverpool’s Institute of Psychology, and colleagues conducted a study to determine the prevalence, symptoms, and characteristics of PES and to test associations of PES symptoms with sociodemographic and clinical characteristics; additionally, the investigators sought to examine the interrelatedness of PES symptoms and explore the emotional valence of PES and its relationship to anxiety and depression.
A total of 179 patients with uveal melanoma enucleated 4 to 52 months previously were included in the study. Patients were asked about three symptoms: pain, visual sensations, and a feeling of seeing through the removed eye. Mood was assessed by the Hospital Anxiety and Depression Scale.
Of the 179 patients, 108 (60.3%) experienced symptoms: 86 (48%) reported visual sensations, 50 (28%) reported seeing through the removed eye, and 42 (23%) reported pain; 14 (7.8%) reported all three symptoms. At the time of the questionnaire, 31 (17%) experienced one or more symptoms daily.
The investigators found that women were more likely to report pain (odds ratio [OR], 2.18; 95% CI, 1.08–4.40). Younger patients at enucleation were more likely to report pain (t=4.13; degrees of freedom (df), 177; P<.001) and visual sensations (t=2.11; df, 177; P<.05). Patients studied sooner after enucleation were more likely to report seeing (Mann-Whitney U, 2343; P<.05). Pain and seeing were intercorrelated (chi-square, 5.47; Φ=0.18; df, 1; P<.05), pain with visual sensations (chi-square, 3.91; Φ=0.15; df, 1; P<.05) and seeing with visual sensations (chi-square, 34.22; Φ=0.45; df, 1; P<.001). Twenty of 108 patients (18.5%) found symptoms disturbing, and 21 of 108 (19.4%) pleasurable. Patients reporting pain were more anxious (OR, 3.53; 95% CI, 1.38–9.03) and more depressed (OR, 13.26; 95% CI, 3.87–46.21).
“Patients should be informed of PES symptoms,” the study authors concluded. “Pain may indicate anxiety or depression; this needs research to determine cause and effect.”
1. Hope-Stone L, Brown SL, Heimann H, Damato B, Salmon P. Phantom eye syndrome [published online ahead of print May 20, 2015]. Ophthalmology. doi:http://dx.doi.org/10.1016/j.ophtha.2015.04.005.
AREDS Scale Changes Predictive of Long-Term Cataract Outcomes
Two-year changes in the severity of lens opacities on the Age-Related Eye Disease Study (AREDS) lens grading scale are predictive of long-term clinically relevant outcomes, according to a study published in Ophthalmology.1
The study included AREDS participants whose eyes were phakic at baseline and free of late-stage age-related macular degeneration throughout the study. The investigators graded baseline and annual lens photographs of AREDS participants (n=3,466 of 4,757; 73%) for severity of cataracts using the AREDS system for classifying cataracts from photographs. They conducted clinical examinations semiannually to collect data on cataract surgery and visual acuity and analyzed the association of the change in lens opacities at 2 years with these outcomes at 5 years with adjusted Cox proportional hazard models.
The investigators reported the adjusted hazard ratios (HRs) for association of progression to cataract surgery at 5 years. For eyes with a nuclear cataract, there was an HR of 2.77 for an increase of 1 unit or more compared with less than a 1-unit change at 2 years (95% CI, 2.07–3.70; P<.001). For eyes with a cortical cataract, there was an HR of 1.91 for an increase of 5% or more in lens opacity in the central 5 mm of the lens compared with less than a 5% increase at 2 years (95% CI, 1.27–2.87; P=.002).
For eyes with a posterior subcapsular cataract, there was an HR of 8.25 for an increase of 5% or more versus less than 5% in the central 5 mm of the lens (95% CI, 5.55–12.29; P<.001). Similarly, HRs of vision loss of 2 lines or more at 5 years for this degree of lens changes at 2 years were the following: nuclear, 1.83 (95% CI, 1.49–2.25; P<.001); cortical, 1.13 (95% CI, 0.78–1.65; P=.519); and posterior subcapsular cataract, 3.05 (95% CI, 1.79–5.19; P<.001).
“The data presented here show that relatively short-term, modest changes in the severity of all three types of lens opacities on the AREDS scale were predictive of long-term clinically relevant outcomes,” the investigators said. “Use of worsening severity of opacities as surrogate outcome variables is likely to facilitate future longitudinal studies of cataract.
“Based on these considerations and our findings, we offer increasing severity of lens opacities on the AREDS scale for classifying cataracts as a possible surrogate end point in follow-up studies of age-related cataract,” he furthered. n
1. Indaram M, Agrón E, Clemons TE, et al. Changes in lens opacities on the Age-Related Eye Disease Study grading scale predict progression to cataract surgery and vision Loss: Age-Related Eye Disease Study Report No. 34. Ophthalmology. 2015:122(5):888-896.
– Compiled by Callan Navitsky, Senior Editor;
and Steve Daily, Executive Editor, News