NSAIDs in combination therapy for the treatment of chronic pseudophakic cystoid macular edema.

PURPOSE: The purpose of this study was to evaluate the addition of topical nonsteroidal antiinflammatory drugs (NSAIDs) to intravitreal corticosteroid and antivascular endothelial growth factor injections for the treatment of chronic cystoid macular edema. METHODS: Thirty-nine patients with chronic pseudophakic cystoid macular edema completed a single-center, randomized, investigator-masked study. All patients were treated with an intravitreal triamcinolone and bevacizumab injection at study entry; the bevacizumab injection was repeated at 1 month. To evaluate the effect of adding an NSAID, patients were randomized to treatment with 1 of 4 topical NSAIDs (diclofenac 0.1%, ketorolac 0.4%, nepafenac 0.1%, and bromfenac 0.09%) or placebo for 16 weeks. RESULTS: At Weeks 12 and 16, both the nepafenac and bromfenac groups showed a significant reduction in retinal thickness compared with that in placebo (nepafenac, P = 0.0048, bromfenac, P = 0.0113). A difference, however, between these 2 NSAID groups was observed in that only the nepafenac group was able to maintain the demonstrated retinal thickness decrease at Weeks 12 and 16. The nepafenac group also experienced a significant improvement in visual acuity at Weeks 12 (P = 0.0084) and 16 (P = 0.0233). The addition of NSAIDs did not produce an increase in mean intraocular pressure over the course of therapy. CONCLUSION: Although NSAID therapy seems to potentiate the improvements produced by corticosteroids and antivascular endothelial growth factor therapy for chronic pseudophakic cystoid macular edema, only nepafenac- and bromfenac-treated eyes showed reduced retinal thickness at 12 weeks and 16 weeks. Furthermore, nepafenac produced a sustained improvement in visual acuity.

Randomized Placebo-Controlled Trial Evaluating the Ophthalmic Safety of Single-Dose Tafenoquine in Healthy Volunteers.

INTRODUCTION: Tafenoquine has been recently registered for the prevention of relapse in Plasmodium vivax malaria. OBJECTIVE: This study assessed the pharmacodynamic effects of 300-mg single-dose tafenoquine on the retina. METHODS: This phase I, prospective, multicenter, randomized, single-masked, placebo-controlled, parallel-group study was conducted between 2 February 2016 and 14 September 2017 at three US study centers. Adult healthy volunteers were randomized (2:1) to receive either a single 300-mg oral dose of tafenoquine or matched placebo on day 1. Ophthalmic assessments, including spectral domain optical coherence tomography (SD-OCT) and fundus autofluorescence (FAF), were conducted at baseline and day 90 and evaluated for pre-determined endpoints by an independent, masked reading center. RESULTS: One subject in each group met the composite primary endpoint for retinal changes identified with SD-OCT or FAF, i.e., one out of 306 (0.3%) with tafenoquine, one out of 161 (0.6%) with placebo. Both cases had unilateral focal ellipsoid zone disruption at day 90 with no effect on best-corrected visual acuity. The tafenoquine-treated subject had this abnormality at baseline, and was enrolled in error. There was no difference in ophthalmic safety between tafenoquine and placebo. CONCLUSION: There was no evidence of any pharmacodynamic effect of 300-mg single-dose tafenoquine on the retina or any short-term clinically relevant effects on ophthalmic safety. This clinical trial is registered with ClinicalTrials.gov (identifier: NCT02658435).

Topical nepafenac as an alternate treatment for cystoid macular edema in steroid responsive patients.

PURPOSE: To evaluate the use of nepafenac 0.1% in patients with cystoid macular edema who are known steroid responders. METHODS: Patients (N = 15) with clinical and angiographic cystoid macular edema (> or = 2 months) and a history of increased intraocular pressure following administration of topical corticosteroids participated in this prospective, open-label, pilot study. All patients were treated with nepafenac 0.1% four times daily for 6 weeks and the dose was tapered off over the ensuing 6 weeks. The total treatment duration was 12 weeks. Visual acuity and retinal thickness were measured. RESULTS: For the entire population, there was a mean significant improvement in visual acuity and retinal thickness at 4 weeks and 12 weeks posttreatment compared with baseline (P < 0.0001). A subgroup analysis revealed that patients with pseudophakic cystoid macular edema (n = 11) had a mean significant improvement in visual acuity and retinal thickness compared with baseline at 4 weeks and 12 weeks posttreatment (P < 0.0001). Although the improvement in the vitreoretinal interface disorders group was not statistically different from baseline (probably due to the outlier), three of the four patients with vitreoretinal interface disorders had improvement in visual acuity and retinal thickness. Nepafenac was well tolerated. CONCLUSION: Nepafenac may be an effective and safe therapy for treating chronic cystoid macular edema in patients who are steroid responders.

Ophthalmoscopy and vitreoretinal surgery in patients with an ARRAY refractive multifocal intraocular lens implant.

We developed a clinical strategy for dealing with situations in which ophthalmoscopic examination and vitreoretinal surgery are difficult in patients with an ARRAY refractive multifocal intraocular lens (IOL) implant. The ARRAY zonal-progressive IOL has a central 2.1-mm distance-vision zone for optically-unobstructed posterior pole observation. A concentric near-vision zone (+3.5-diopter add) surrounds this central zone. Optical ray-tracing is used to determine how a 2.1-mm pupil limitation restricts monocular and binocular retinal image size in head-mounted, slit-lamp, and operating microscope ophthalmoscopy. A 2.1-mm pupil decreases the retinal field of view of high magnification, narrow field lenses much more than that of wider-field, lower magnification lenses. This "worst-case" analysis suggests an ophthalmoscopic strategy, but is not strictly valid for the ARRAY lens because the near-vision zone surrounding its 2.1-mm central zone is not opaque. The near-vision zone contributes defocused information to the ophthalmoscopic image, diminishing its resolution and depth information. Wide-field, low magnification lenses are potentially less problematic than higher magnification lenses for examining and treating patients with an ARRAY IOL implant. This strategy is useful for panretinal photocoagulation or photodynamic therapy, but not for procedures requiring high magnification stereoscopic vision such as macular vitreoretinal surgery.

Incidence of postoperative cystoid macular edema by a single surgeon.

OBJECTIVE: To evaluate the clinical and angiographic incidence of cystoid macular edema (CME) after cataract surgery, and to determine the impact of intraoperative triamcinolone acetonide. METHODS: This is a prospective, single-center trial looking at 81 eyes of 61 patients who underwent clear-cornea incision phacoemulsification with lens implantation under topical anesthesia by a single surgeon. Outcome measures included clinical and angiographic CME, the impact of operative time, medications, and systemic disease on the presence of CME. RESULTS: Eight eyes (9.87%) demonstrated angiographic CME at the one-week and six-week follow-up visits. Two eyes showed evidence of clinical CME (2.46%) on examination. Subjects with diabetes had an increased risk of angiographic CME. CONCLUSION: The incidence of clinically significant and angiographic CME in this study is confirmatory of previous studies in the literature. The use of intraoperative subconjunctival triamcinolone acetonide did not appear to significantly reduce the development of post-operative CME.

Ocular oxygen consumption: estimates using vitreoperfusion in the cat.

PURPOSE: Little is known about the ocular oxygen consumption rate (QO2) in human diseases. Alterations in QO2 must occur in many conditions, such as retinal ischemia. We present a method of estimating QO2 that eventually could be used in patients during vitrectomy surgery. METHODS: We performed vitreoperfusion (i.e., perfusion of the vitreous cavity after vitrectomy) in 14 cat eyes with no ocular blood flow. The solution contained nutrients at a high partial pressure of oxygen (PO2). In eight eyes, the retinas were undisturbed (Group 1), and in six eyes, we excised the retinas (Group 2). We estimated QO2 in both groups on the basis of the temporal decline of PO2 in the vitreoperfusion solution according to a pharmacokinetic model. RESULTS: The mean and standard deviation of QO2 was 3.2 +/- 0.8 microL/min in Group 1 and 0.4+/- 0.7 microL/min in Group 2, with the difference being the retinal contribution, 88%. In Group 1, metabolism, bulk flow, and diffusion accounted for 82, 13, and 5%, respectively, of the oxygen loss from the vitreoperfusion solution. CONCLUSION: We estimated ocular oxygen consumption by means of vitreoperfusion. Eventually, the pathophysiology of human diseases may be clarified by similar measurements during vitrectomy.