Ivo Guber

ISRCTN12125882 - Influence of topical anti-VEGF (Ranibizumab) on the outcome of filtration surgery for glaucoma - Study Protocol

BackgroundExcessive wound healing, with scarring of the episcleral tissue or encapsulation of the filtering bleb is the main reason for failure in trabeculectomy. Ranibizumab, an inhibitor of the Vascular Endothelial Growth Factor (VEGF), is seen as a promising candidate to prevent or treat extensive wound healing. We describe the design of a two phased study, i) assessing the local tolerability and safety of topical ranibizumab and ii) assessing the efficacy of topical ranibizumab against placebo in patients who underwent trabeculectomy with mitomycin C combined with phacoemulsification and intra ocular lens (IOL) implantation.Methods/DesignIn the first phase five patients that had trabeculectomy with mitomycin C combined with phacoemulsification and IOL implantation will be treated with topical ranibizumab (Lucentis®) eye drops (2 mg/ml) four times daily for one month. The treatment will be started at the first postoperative day. Patients will be assessed for local and systemic side effects using a standardised schedule. In the second phase, after successful completion of phase 1, consenting eligible patients who underwent trabeculectomy with mitomycin C combined with phacoemulsification and IOL implantation will be randomised to either receive topical ranibizumab eye drops (2 mg/ml) four times daily for 1 month or placebo (BSS 4x/d for 1 month). Patients will be reviewed weekly for 4 weeks until conjunctival sutures are removed. Further follow up examinations are planned after 3 and six months. Assessment of differences in the intraocular eye pressure will be considered primary, and bleb appearance/vascularisation using a standardized photography and the Moorfields bleb grading system, postoperative intraocular pressure and conjunctival wound healing problems will be considered secondary outcome parameters.DiscussionAnti-VEGF-antibodies might be more effective in preventing scaring and might have fewer toxic side effects than the currently used anti-metabolites and may replace them in the long term.Trial RegistrationISRCTN: ISRCTN12125882

Reduced precision of the Pentacam HR in eyes with mild to moderate keratoconus.

Anterior Sr r SR R R R K1 (D) 0.08 0.22 0.06 0.16 0.21 0.35 K2 (D) 0.12 0.33 0.15 0.41 0.04 0.35 Km (D) 0.14 0.39 0.13 0.36 0.18 0.47 Axis ( ) 3.91 10.84 2 5.56 12.60 6.17 Astigmatism 0.04 0.11 0.16 0.45 0.11 0.02 Q value (30 ) 0.06 0.17 0.06 0.17 0.19 0.26 Rper (mm) 0.03 0.08 0.02 0.05 0.19 0.15 Rmin (mm) 0.07 0.19 0.09 0.24 0.04 0.03 Posterior K1 (D) 0.07 0.19 0.05 0.13 0.22 0.28 K2 (D) 0.1 0.28 0.1 0.27 0.01 0.17 Km (D) 0.04 0.11 0.05 0.14 0.19 0.23 Axis ( ) 8.34 23.12 10.12 28.06 33.47 16.28 Astigmatism 0.01 0.03 0.09 0.26 0.10 0.07 Q value (30 ) 0.07 0.19 0.18 0.5 0.41 0.57 Rper (mm) 0.05 0.14 0.04 0.1 0.10 0.03 Rmin (mm) 0.06 0.17 0.07 0.2 0.19 0.06 Summary data Kmax front (D) 0.71 1.97 0.83 2.3 0.47 0.30 x Axis (mm) 0.06 0.17 0.13 0.36 0.48 0.40 y Axis (mm) 0.17 0.47 0.12 0.33 0.12 0.30 Corneal volume (mm) 0.58 1.61 1.21 3.34 1.78 0.73 KPD (D) 0.11 0.30 0.1 0.29 0.06 0.09 AC volume (mm) 13.6 37.70 5.44 15.07 3.74 8.95 AC angle ( ) 2.83 7.84 4.01 11.1 3.62 0.42 AC depth (mm) 0.04 0.11 0.02 0.04 0.00 0.00 Pupil diameter 0.16 0.44 0.09 0.25 0.98 0.86 Pachymetry Pupil center, mm 5.58 15.47 9.48 26.27 2.13 2.72 x Axis (mm) 0.04 0.11 0.02 0.05 0.04 0.04 y Axis (mm) 0.09 0.25 0.01 0.03 0.01 0.12 Apex (mm) 4.44 12.31 10.65 29.51 6.38 2.51 TCT (mm) 2.13 5.90 9.61 26.64 5.13 0.87 Corneal volume (mm) 3-mm diameter 0.01 0.03 0.06 0.15 0.03 0.03 5-mm diameter 0.06 0.17 0.13 0.37 0.03 0.09 7-mm diameter 0.14 0.39 0.42 1.17 0.34 0.00 Indices ISV 3.02 8.37 0.77 2.14 7.92 4.92 IVA 0.03 0.08 0.04 0.12 0.16 0.12 KI 0.01 0.03 0.03 0.08 0.08 0.07 CKI 0.01 0.03 0 0.01 0.01 0.01 IHA 10.8 29.94 14.9 41.29 36.31 35.95 IHD 0 0.01 0 0.01 0.00 0.00

Clinical Outcomes and Cataract Formation Rates in Eyes 10 Years After Posterior Phakic Lens Implantation for Myopia

Importance Intraocular collamer lenses (ICLs) are posterior chamber phakic lenses that provide a refractive surgery option for those with high myopia or astigmatism. The short-term and midterm results indicate good refraction stability, efficacy, and safety. Cataract has been suggested to be an important long-term complication of ICL implantation. Objective To report the rates of cataract development and refractive outcomes 10 years after ICL implantation. Design, Setting, and Participants The study included 133 eyes of 78 patients undergoing consecutive V4 model ICL implantations, which took place from January 1, 1998, through December 31, 2004, at Jules-Gonin Eye Hospital, Lausanne, Switzerland. Data analysis was performed from January 1, 2014, to May 31, 2014. The lenses implanted were as follows: 53 V4 model ICLs of -15.5 D or greater, 73 V4 model ICLs of less than -15.5 diopter (D), and 7 V4 model toric ICLs for myopia. Main Outcomes and Measures Rate of cataract surgery, lens opacity, ocular hypertension, refractive safety, predictability, and stability. Results A total of 133 eyes of 78 patients (34 men and 44 women, with a mean [SD] age of 38.8 [9.2] years at enrollment) met the inclusion criteria. The rate of lens opacity development was 40.9% (95% CI, 32.7%-48.8%) and 54.8% (95% CI, 44.7%-63.0%) at 5 and 10 years, respectively. Phacoemulsification was performed in 5 eyes (4.9%; 95% CI, 1.0%-8.7%) and 18 eyes (18.3%; 95% CI, 10.1%-25.8%) at 5 and 10 years after ICL implantation, respectively. The vault height (distance between the posterior ICL surface and anterior lens surface) measured a mean (SD) of 426 (344) μm immediately postoperatively, decreasing to 213 (169) μm at 10 years. A smaller vault height was associated with the development of lens opacity and phacoemulsification (P = .005 and .008, respectively). The intraocular pressure was 15 mm Hg postoperatively, and there was no significant increase in intraocular pressure observed until the 10-year follow-up (16 mm Hg, P = .02). At 10 years, 12 eyes (12.9%; 95% CI, 5.6%-19.6%) had developed ocular hypertension that required topical medication. At 10 years, the mean (SD) safety index was 1.25 (0.57), with a manifest spherical equivalent of -0.5 D at 1-year postoperatively vs -0.7 D at 10 years postoperatively in eyes aimed at emmetropia. Conclusions and Relevance This retrospective single center study indicates that ICL implantation provides good long-term safety and stability of refraction in patients with high myopia compared with similar short-term studies. However, the rates of cataract formation and ocular hypertension at 10 years have important clinical implications, and as such this information should be part of the available patient information before ICL implantation.

Correcting Interdevice Bias of Horizontal White-to-White and Sulcus-to-Sulcus Measures Used for Implantable Collamer Lens Sizing

PURPOSE To assess the agreement and repeatability of horizontal white-to-white (WTW) and horizontal sulcus-to-sulcus (STS) diameter measurements and use these data in combination with available literature to correct for interdevice bias in preoperative implantable collamer lens (ICL) size selection. DESIGN Interinstrument reliability and bias assessment study. METHODS A total of 107 eyes from 56 patients assessed for ICL implantation at our institution were included in the study. This was a consecutive series of all patients with suitable available data. The agreement and bias between WTW (measured with the Pentacam and BioGraph devices) and STS (measured with the HiScan device) were estimated. RESULTS The mean spherical equivalent was -8.93 ± 5.69 diopters. The BioGraph measures of WTW were wider than those taken with the Pentacam (bias = 0.26 mm, P < .01), and both horizontal WTW measures were wider than the horizontal STS measures (bias >0.91 mm, P < .01). The repeatability (Sr) of STS measured with the HiScan was 0.39 mm, which was significantly reduced (Sr = 0.15 mm) when the average of 2 measures was used. Agreement between the horizontal WTW measures and horizontal STS estimates when bias was accounted for was г = 0.54 with the Pentacam and г = 0.64 with the BioGraph. CONCLUSIONS Large interdevice bias was observed for WTW and STS measures. STS measures demonstrated poor repeatability, but the average of repeated measures significantly improved repeatability. In order to conform to the US Food and Drug Administrations accepted guidelines for ICL sizing, clinicians should be aware of and account for the inconsistencies between devices.

Choroidal metastases in testicular choriocarcinoma, successful treatment with chemo- and radiotherapy: a case report

BackgroundChoriocarcinoma is a very rare cause of ocular metastasis. Only 18 male patients have been reported on, 4 of whom survived, but with significant loss of vision.Case presentationA 26-year-old Caucasian man, suffering from testicular choriocarcinoma with pulmonary, cerebral, renal, hepatic and osseous metastases, underwent left radical orchiectomy. While being treated with chemotherapy, he presented with loss of vision in the left eye. Ophthalmoscopy revealed bilateral non-pigmented, hemorrhagic choroidal tumours, compatible with secondary lesions. Continued chemotherapy and stereotactic radiotherapy of the skull and spine lead to full remission with excellent vision, after more than 4 years of follow up.ConclusionTesticular choriocarcinoma is an exceptional cause of choroidal metastasis, potentially asymptomatic and with specific clinical features. Radiotherapy can complement radical orchiectomy and chemotherapy, to achieve full remission and maintain good vision.

Repeated Intrastromal Injections of Voriconazole in Combination with Corneal Debridement for Recalcitrant Fungal Keratitis - a Case Series.

BACKGROUND To report the use of intrastromal voriconazole injections combined with corneal debridement to treat deep recalcitrant fungal keratitis. HISTORY AND SIGNS Three patients (2 female and 1 male) with culture proven fungal keratitis (1 Fusarium, 1 Candida, 1 Pseudallescheria boydii) were included in this study. The patients were treated with repeated intrastromal voriconazole (100 mg/1 ml) in combination with corneal debridement. THERAPY AND OUTCOME The mean age of the patients was 65 years. The mean number of injections was 5. The patients were injected every 2-3 days. This technique required repeated corneal debridement to achieve complete resolution in these three cases. CONCLUSIONS Repeated intrastromal injection of voriconazole in combination with corneal debridement appears to be an effective and safe way to treat recalcitrant fungal keratitis, even in Fusarium keratitis.

Tolerance and Relative Utility: Two Proposed Indices for Comparing Change in Clinical Measurement Noise Between Different Populations (Repeatability) or Measurement Methods (Agreement)

Reaching a consensus in terms of interchangeability and utility (i.e., disease detection/monitoring) of a medical device is the eventual aim of repeatability and agreement studies. The aim of the tolerance and relative utility indices described in this report is to provide a methodology to compare change in clinical measurement noise between different populations (repeatability) or measurement methods (agreement), so as to highlight problematic areas. No longitudinal data are required to calculate these indices. Both indices establish a metric of least to most effected across all parameters to facilitate comparison. If validated, these indices may prove useful tools when combining reports and forming the consensus required in the validation process for software updates and new medical devices.

Reproducibility of Retinal Nerve Fiber Layer Measurements with Manual and Automated Centration in Healthy Subjects Using Spectralis Spectral-Domain Optical Coherence Tomography

Objective. The aim of this study was to test the reproducibility of the Heidelberg Spectralis SD-OCT and to determine if provided software retest function for follow-up exam is superior to manual centration. Design. Prospective, cross-sectional study. Participants. 20 healthy subjects. Methods. All subjects underwent SD-OCT testing to determine retinal nerve fiber layer (RNFL) measurements sequentially on two different days and with two different centration techniques. Within-subject standard deviation, coefficient of variation, and intraclass correlation coefficient were used to assess reproducibility. Results. RNFL measurements showed high reproducibility, low within-subject standard deviation (1.3), low coefficient of variation (0.63%), and low intra-class correlation coefficient (0.98 (95% CI 0.97–0.99)) in the automated centration and manual centration groups for average RNFL Thickness. Quadrants showed slightly higher variability in the manual group compared to the automated group (within-subject standard deviation 2.5–5.3 versus 1.1–2.4, resp.). Conclusions. SD-OCT provides high-resolution RNFL measurements with high reproducibility and low variability. The re-test function allows for easier recentration for longitudinal examinations with similar results in average RNFL, but less variability in quadrant RNFL. SD-OCT high reproducibility and low variability is a promising fact and should be further evaluated in longitudinal studies of RNFL.