Clinical Comparison of the Performance of Two Marketed Ophthalmic Viscoelastic Devices (OVDs): The Bacterially Derived Healon PRO OVD and Animal-Derived Healon OVD.

This clinical investigation compared the clinical performance of two marketed ophthalmic viscoelastic devices (OVDs): the bacterially derived Healon PRO OVD (test) and the animal-derived Healon OVD (control) under normal use conditions during cataract removal and lens implantation. This prospective, multicenter, randomized, parallel, participant/evaluator masked, postmarket investigation enrolled 139 subjects (170 eyes), 116 (143 eyes) of which were treated (73 test; 70 control group). Both test and control OVDs were used, at a minimum, to inflate the anterior chamber and protect the endothelium prior to cataract extraction according to the standard procedure. The surgeon completed a postsurgery OVD clinical performance questionnaire, and intraocular pressure (IOP) was measured before surgery and at the 1 day postoperative visit with Goldmann applanation tonometry. Any IOP measurement of 30 mmHg or higher was considered a "spike" and recorded as a study-specific, serious adverse event. The bacterially derived Healon PRO OVD was found to be statistically noninferior to the overall clinical performance of the animal-derived Healon OVD control; thus, the primary hypothesis was satisfied. There were no statistically significant differences between OVD groups for any of the additional endpoints relating to IOP changes or to safety, thus satisfying additional hypotheses. The Healon PRO OVD showed statistically significant improvements in surgeon ratings for ease of injectability, transparency/visibility, and ease of IOL placement. The safety profile was also similar between OVD groups with regards to serious and/or device-related adverse events, as well as medical and lens findings. The results of this clinical investigation support the safety and effectiveness of the bacterially derived, currently marketed Healon PRO OVD and indicate that the intraocular surgical performance was similar between the two OVDs.

Reproducibility and reliability of retinal and optic disc measurements obtained with swept-source optical coherence tomography in a healthy population.

PURPOSE: To analyze the reproducibility of macular and peripapillary thickness measurements, and optic nerve morphometric data obtained with Triton Optical coherence tomography (OCT) in a healthy population. STUDY DESIGN: Observational cross sectional study. MATERIAL AND METHODS: A total of 108 eyes underwent evaluation using the Triton Swept Source-OCT. A wide protocol was used and measurements in each eye were repeated three times. Morphometric data of the optic nerve head, full macular thickness, ganglion cell layer (GCL) and retinal nerve fiber layer thickness (RNFL) were analyzed. For each parameter, the coefficient of variation (COV) and the intra-class (ICC) correlation values were calculated. RESULTS: Measurements were highly reproducible for all morphometric measurements of the optic disc, with a mean COV of 6.36%. Macular full thickness showed good COV and ICC coefficients, with a mean COV value of 1.00%. Macular GCL thickness showed a mean COV value of 3.06%, and ICC higher than 0.787. Peripapillary RNFL thickness showed good COV and ICC coefficients, with a mean COV value of 8.31% and ICC higher than 0.684. The inferotemporal sector showed the lowest ICC (0.685). CONCLUSIONS: Triton OCT presents good reproducibility values in measurements corresponding to retinal parameters, with macular measurements showing the highest reproducibility rates. Peripapillary RNFL measurements should be evaluated with caution.

VISUAL FUNCTION AND RETINAL CHANGES IN PATIENTS WITH BIPOLAR DISORDER.

PURPOSE: To evaluate visual and retinal changes in patients with bipolar disorder. To analyze the correlation between structural changes and visual function parameters. METHODS: Thirty patients with bipolar disorder and 80 healthy controls underwent visual function evaluation with Early Treatment Diabetic Retinopathy Study charts at 100%, 2.50%, and 1.25% contrast, Pelli-Robson chart, and color vision Farnsworth and Lanthony tests. Analysis of the different retinal layers was performed using Spectralis optical coherence tomography with automated segmentation software. Correlation analysis between structural and functional parameters was conducted. RESULTS: Patients with bipolar disorder presented worse color vision compared with controls (Lanthony's index, P = 0.002). Full macular thickness, the retinal nerve fiber layer (RNFL), ganglion cell layer, and inner plexiform layer were reduced in patients compared with healthy individuals (P < 0.005). The inner nuclear layer was significantly thickened in patients (P < 0.005). Peripapillary RNFL thickness was reduced in all temporal sectors (P < 0.005). Significant correlations were found between visual acuity and the RNFL thickness, the Pelli-Robson score and the inner plexiform layer, and between the Lanthony's color index and the ganglion cell layer thickness. CONCLUSION: Patients with bipolar disorder present quantifiable thinning of the macular RNFL, ganglion cell layer, and inner plexiform layer, as well as in the peripapillary RNFL thickness, and increasing thinning in the inner nuclear layer.

Ability of swept source OCT to detect retinal changes in patients with bipolar disorder.

PURPOSE: To evaluate the ability of swept source optical coherence tomography (SS-OCT) to detect retinal changes in patients with bipolar disorder (BD). METHODS: Twenty-three patients with BD and 23 controls underwent retinal evaluation using SS deep range imaging (DRI) Triton OCT. Full retinal thickness, the ganglion cell layer (GCL), the retinal nerve fiber layer (RNFL), and choroidal thickness were evaluated with automated segmentation software. RESULTS: Patients with BD were shown to have significant thinning of the macular full retinal thickness in the center (p = 0.049), inner temporal (p = 0.045), inner nasal (p = 0.016), and inner inferior (p = 0.016) of the ETDRS areas. The macular GCL layer was reduced in patients compared with controls (average, p = 0.002; superior, p = 0.009; superonasal, p = 0.009; inferonasal, p = 0.003; and inferior, p = 0.009). Peripapillary reduction of full retinal thickness (average, p < 0.001; superotemporal, p < 0.001; superonasal, p = 0.003; nasal, p = 0.005; and inferotemporal, p = 0.033), GCL (nasal, p = 0.025), and RNFL thickness (average, p = 0.002; superotemporal, p < 0.001; and superonasal, p = 0.045) was observed in patients compared with controls. No significant differences were observed in choroidal thickness measurements. CONCLUSIONS: BD patients were shown to have quantifiable thinning of full retinal thickness and the GCL in the macular area, as well as a peripapillary reduction of the RNFL and GCL thickness. The analysis of the retinal sublayers with SS-OCT may be a useful indicator to show degeneration and monitor disease progression in bipolar disorder.

Early Changes in Visual Quality and Corneal Structure after DMEK: Does DMEK Approach Optical Quality of a Healthy Cornea?

PURPOSE: To evaluate early changes in visual function and visual quality parameters after Descemet membrane endothelial keratoplasty (DMEK) and to compare the outcomes with healthy controls. METHODS: Thirteen patients who underwent DMEK and 14 controls were evaluated. All subjects underwent visual function evaluation, including visual acuity under photopic and mesopic lighting conditions and contrast sensitivity (CSV) tests CSV 1000 and Pelli-Robson. Corneal parameters were assessed with Oculus Pentacam. Corneal mean keratometry (Km), corneal densitometry values, and low and high order aberrations (LOA and HOA) were recorded. In DMEK patients, all tests were performed before surgery and 1 and 6 months after surgery. RESULTS: In patients who underwent DMEK, photopic visual acuity improved from 0.59 to 0.31 at 1 month (p=0.013) and 0.13 at 6 months (p=0.008); mesopic visual acuity and all contrast sensitivity values (both CSV and Pelli-Robson test) improved significantly in the first month (p < 0.005). A significant decrease was observed in corneal density in the 0-2 mm ring (from 43.83 to 35.60, p=0.043) and mean posterior Km (from -5.84 to -6.80, p=0.005) in the first month. Corneal HOAs and all corneal densities improved at 6 months after DMEK (p < 0.05). All visual function parameters and corneal aberrations remained lower and higher, respectively, compared with healthy controls (p < 0.05). Corneal densities were comparable with controls at 6 months after DMEK (p > 0.05). CONCLUSIONS: Patients undergoing DMEK present visual function improvement and a decrease in corneal density at 1 month after surgery. Decrease in corneal posterior HOAs can be observed at 6 months. However, visual function outcomes and corneal aberrations remained worse compared with healthy controls.

Evaluation of Early Graft Detachment After Descemet Membrane Endothelial Keratoplasty Using New Swept-Source Optical Coherence Tomography.

PURPOSE: To evaluate the ability of Swept-source optical coherence tomography (SS-OCT) in detecting early endothelial graft detachment after Descemet membrane endothelial keratoplasty (DMEK) and to determine the possible causes of graft detachment using 2 different protocols for anterior segment (AS) imaging. METHODS: Eight eyes from 8 consecutive DMEK surgeries were evaluated. High-resolution images were captured with SS-OCT using 2 different radial protocols for AS imaging (16- and 6-mm radial protocols). Central and peripheral corneal changes were evaluated. RESULTS: All eyes developed early graft detachment detectable with the SS-OCT. The 16-mm radial protocol scanned the cornea detecting early graft detachment in 6 out of 8 cases. The 6-mm radial protocol provided detailed images of the cornea, detecting early detachment in all cases. Stromal irregularities and small remnants only detectable using SS-OCT were the possible cause of detachment in 3 cases. One of the 8 eyes had air reinjection. The detachment in that eye was apparent by slit-lamp examination. The detachments spontaneously resolved in the other 7 eyes. AS SS-OCT evaluation was found to have added diagnostic value to biomicroscopy in 5 of these eyes (64.5%). CONCLUSIONS: AS SS-OCT is sensitive in detecting early graft detachment after DMEK. The 16-mm radial protocol of Triton SS-OCT is superior regarding quick scan of the entire cornea providing a general visualization of the DMEK graft. The 6-mm radial protocol provides detailed corneal imaging of a selected area, which is useful for evaluating structural alterations that are not detectable with larger scans and may affect the adherence of the endothelial graft.