The Conjunctiva in Normal Tension Glaucoma Patients is Thinner Than in Primary Open-Angle Glaucoma Patients: A Comparative Histologic Study.

PURPOSE: To compare histologically the thickness of conjunctival specimens of normal tension glaucoma (NTG) patients with primary open-angle glaucoma (POAG) patients. MATERIALS AND METHODS: In this prospective study, 54 patients scheduled for trabeculectomy were categorized into NTG and POAG based on their maximum untreated intraocular pressure at any time (IOPmax) as measured by Goldmann applanation tonometry. Sixteen patients with NTG (IOPmax≤21 mm Hg) and 36 patients with high tension POAG (IOPmax>21 mm Hg) were included in the study. Biopsies were taken from the superior bulbar conjunctiva during trabeculectomy. The specimens were fixed in formalin, embedded in methacrylate, histologically sectioned, stained with toluidine blue, and analyzed with a light microscope. The stromal conjunctival thickness (CT) was measured in a standardized way and compared between the 2 groups. Intergroup comparisons were performed using the Mann-Whitney U test for continuous variables and the Fisher exact test for categorical variables. The correlation between the central cornea thickness (CCT) and the CT was investigated by the Spearman test. RESULTS: The stromal CT was significantly thinner in NTG compared with POAG (64±31 vs. 103±44 µm, respectively; P=0.002). Stromal CT of the whole group was positively correlated with IOPmax (r=0.41; P=0.002; 95% confidence interval, 0.15-0.62) but not with central cornea thickness (r=-0.005; P=0.97; 95% confidence interval, -0.28 to 0.27). CONCLUSIONS: The conjunctiva in patients with NTG was thinner than in POAG patients. This finding is an additional feature in the pattern of thinner ocular structures in patients with NTG.

The Effect of Trabeculectomy on Astigmatism.

PURPOSE: To investigate the change in corneal astigmatism after trabeculectomy. PATIENTS AND METHODS: Between January and April 2012, patients who underwent a primary trabeculectomy were enrolled in this prospective study. We measured the visual acuity, automated keratorefractometry, and the intraocular pressure preoperatively and postoperatively at 1, 3, and 6 months. Changes in astigmatism were quantified using the vector analysis described by Cravy. A Friedman test and a linear model for longitudinal measures were used to compare changes in the refraction and the intraocular pressure. A binomial test was used to compare the proportion of eyes with a shift in astigmatism with or against-the-rule. RESULTS: A total of 47 eyes (47/48 patients) were included for analysis. The mean (±SD) intraocular pressure decreased from 17.5 ± 5.4 mmHg preoperatively to 9.8 ± 4.0 mmHg after 6 months (P<0.001). At this time-point, 32/47 eyes showed a shift in astigmatism with-the-rule (P=0.02), with a median difference in cylinder of +0.50 D (range, 0 to 4 D) (P=0.004). The mean (±SD) axis of the positive cylinder changed from 169 ± 148 to 135 ± 146 degrees after 6 months (P=0.12) and the mean (±SD) spherical equivalent changed from -0.47 ± 2.27 to -0.07 ± 1.93 D (P=0.15). The mean (±SD) logMAR was 0.17 ± 0.22 preoperatively and 0.14 ± 0.14 after 6 months (P=0.9). CONCLUSIONS: Trabeculectomy induced a small but statistically significant shift in astigmatism with-the-rule after 6 months. The spherical equivalent did not change compared with the preoperative value. Most often, glasses will not need to be changed after trabeculectomy.

Predictive value of heidelberg retina tomograph parameters for the development of glaucoma in the European glaucoma prevention study.

PURPOSE: To determine whether baseline Heidelberg Retina Tomograph (HRT) measurements of the optic disc are associated with the development of open-angle glaucoma (OAG) in individuals with ocular hypertension in the European Glaucoma Prevention Study (EGPS). DESIGN: Retrospective analysis of a prospective, randomized, multicenter, double-masked, controlled clinical trial. METHODS: There were 489 participants in the HRT Ancillary Study to the EGPS. Each baseline HRT parameter was assessed in univariate and multivariate proportional hazards models to determine its association with the development of OAG. Proportional hazards models were used to identify HRT variables that predicted which participants in the EGPS had developed OAG. Development of OAG was based on visual field and/or optic disc changes. RESULTS: At a median follow-up time of about 5 years, 61 participants developed OAG. In multivariate analyses, adjusting for randomization arm, age, baseline IOP, central corneal thickness, pattern standard deviation, and HRT disc area, the following HRT parameters were associated with the development of OAG: the "outside normal limits" classification of the Frederick Mikelberg (FSM) discriminant function (hazard ratio [HR] 2.51, 95% confidence interval [CI]: 1.45-4.35), larger mean cup depth (HR 1.64, 95% CI: 1.21-2.23), cup-to-disc area ratio (HR 1.43, 95% CI: 1.14-1.80), linear cup-to-disc ratio (HR 1.43, 95% CI: 1.13-1.80), cup area (HR 1.33, 95% CI: 1.08-1.64), smaller rim area (HR 1.33, 95% CI: 1.07-1.64), larger cup volume (HR 1.30, 95% CI: 1.05-1.61), smaller rim volume (HR 1.25, 95% CI: 1.01-1.54), larger maximum cup depth (HR 1.18, 95% CI: 1.01-1.36), and cup shape measure (HR 1.18, 95% CI: 1.01-1.36). CONCLUSIONS: Several baseline HRT parameters, alone or in combination with baseline clinical and demographic factors, were significantly associated with the development of OAG among the EGPS participants.

Latanoprost for open-angle glaucoma (UKGTS): a randomised, multicentre, placebo-controlled trial.

BACKGROUND: Treatments for open-angle glaucoma aim to prevent vision loss through lowering of intraocular pressure, but to our knowledge no placebo-controlled trials have assessed visual function preservation, and the observation periods of previous (unmasked) trials have typically been at least 5 years. We assessed vision preservation in patients given latanoprost compared with those given placebo. METHODS: In this randomised, triple-masked, placebo-controlled trial, we enrolled patients with newly diagnosed open-angle glaucoma at ten UK centres (tertiary referral centres, teaching hospitals, and district general hospitals). Eligible patients were randomly allocated (1:1) with a website-generated randomisation schedule, stratified by centre and with a permuted block design, to receive either latanoprost 0·005% (intervention group) or placebo (control group) eye drops. Drops were administered from identical bottles, once a day, to both eyes. The primary outcome was time to visual field deterioration within 24 months. Analyses were done in all individuals with follow-up data. The Data and Safety Monitoring Committee (DSMC) recommended stopping the trial on Jan 6, 2011 (last patient visit July, 2011), after an interim analysis, and suggested a change in primary outcome from the difference in proportions of patients with incident progression between groups to time to visual field deterioration within 24 months. This trial is registered, number ISRCTN96423140. FINDINGS: We enrolled 516 individuals between Dec 1, 2006, and March 16, 2010. Baseline mean intraocular pressure was 19·6 mm Hg (SD 4·6) in 258 patients in the latanoprost group and 20·1 mm Hg (4·8) in 258 controls. At 24 months, mean reduction in intraocular pressure was 3·8 mm Hg (4·0) in 231 patients assessed in the latanoprost group and 0·9 mm Hg (3·8) in 230 patients assessed in the placebo group. Visual field preservation was significantly longer in the latanoprost group than in the placebo group: adjusted hazard ratio (HR) 0·44 (95% CI 0·28-0·69; p=0·0003). We noted 18 serious adverse events, none attributable to the study drug. INTERPRETATION: This is the first randomised placebo-controlled trial to show preservation of the visual field with an intraocular-pressure-lowering drug in patients with open-angle glaucoma. The study design enabled significant differences in vision to be assessed in a relatively short observation period. FUNDING: Pfizer, UK National Institute for Health Research Biomedical Research Centre.

Retinal oxygen metabolism in healthy subjects and glaucoma patients.

BACKGROUND: To test whether retinal oxygen metabolism is different in glaucoma patients compared with healthy subjects. METHODS: This was a two-centre study where retinal vessel oxygen saturation was measured in glaucoma patients and healthy individuals with a non-invasive spectrophotometric retinal oximeter. Visual fields were obtained in the glaucoma patients. RESULTS: No statistical difference was found in retinal oxygen saturation in arterioles (p=0.16), venules (p=0.16) and arteriovenous difference (p=0.24) when all glaucoma patients (n=74) were compared with healthy individuals (n=89). When patients with advanced glaucoma (visual field mean defect (MD ≥ 10 dB, n=21)) were compared with healthy individuals, the oxygen saturation in venules was higher in glaucoma patients (58.2% ± 5.4% vs 53.8% ± 6.4%; p=0.0054, mean ± SD) and the arteriovenous difference was lower in glaucoma patients (36.4% ± 4.7% vs 39.5% ± 5.7%; p=0.021). In glaucoma patients with mild glaucoma (visual field MD ≤ 5 dB, n=33), no statistical differences were found in retinal oxygen saturation compared with healthy individuals. CONCLUSIONS: Glaucoma patients with advanced glaucoma have higher oxygen saturation in venules and lower arteriovenous difference in oxygen saturation compared with healthy individuals. The decreased arteriovenous difference in severe glaucoma may be related to lower oxygen consumption secondary to neuropathy.

Rates of visual field loss before and after trabeculectomy.

PURPOSE: To compare the rates of change in the visual field (VF) in patients with glaucoma before and after trabeculectomy. METHODS: Of 52 eyes of 52 patients with different types of chronic glaucoma who underwent first trabeculectomy were evaluated retrospectively. Pre- and postoperative-automated visual fields measured by the same technique were compared to detect differences in rates of change. Rates of VF loss before and after trabeculectomy were calculated using mean deviation (MD). Linear mixed models were used to compare the rates of change in the VF before and after trabeculectomy. RESULTS: The mean follow-up period pre- and post-trabeculectomy was 3.9 years (min 0.9, max 10.7) and 3.8 years (min 2.0, max 8.0), respectively. The intraocular pressure (IOP) decreased from 18.1 mmHg (SD = 4.7) before trabeculectomy to 11.1 mmHg (SD = 2.9) at the last follow-up after trabeculectomy. The rate of MD loss was reduced with 56% on average, from -0.36 dB/year before surgery to -0.16 dB/year after surgery (p = 0.15). CONCLUSION: Trabeculectomy considerably decreased the rates of change in the glaucomatous visual field.

Intracameral bevacizumab as an adjunct to trabeculectomy: a 1-year prospective, randomised study.

AIMS: To investigate the efficacy and safety of a single intracameral bevacizumab injection to improve the outcome of trabeculectomy. METHODS: A 12-month, prospective, randomised, double-masked, placebo-controlled trial. Patients with medically uncontrolled open-angle glaucoma scheduled for a primary trabeculectomy were recruited and randomised to receive 50 µL of either bevacizumab (1.25 mg) or placebo (balanced salt solution) peroperatively. Absolute success was defined as intraocular pressure (IOP) ≤18 mm Hg and >5 mm Hg with at least 30% reduction from baseline and no loss of light perception. Success through the use of additional medical and/or surgical IOP-lowering treatments was defined as qualified success. RESULTS: 138 patients completed a 12-month follow-up, 69 of whom were in the bevacizumab treated group. IOP at 1 year postoperatively was significantly lower than baseline (placebo: 25.6±9.9 mm Hg vs 11.5±3.9 mm Hg, p<0.01; bevacizumab: 24.8±8.1 mm Hg vs 11.9±3.8 mm Hg, p<0.01), with no difference between treatment groups (p=0.69). However, absolute success was higher in the bevacizumab group (71% vs 51%, p=0.02), with the need for IOP-lowering interventions (needlings) being lower in this group (12% vs 33%, p=0.003). Complication rates were low and comparable between groups. CONCLUSIONS: Peroperative administration of intracameral bevacizumab significantly reduces the need for additional interventions during the follow-up of patients undergoing trabeculectomy.

Oximetry in glaucoma: correlation of metabolic change with structural and functional damage.

PURPOSE: To determine whether retinal vessel oxygen saturation in patients with glaucoma is associated with structural optic disc and retinal nerve fibre layer (RNFL) changes and visual field (VF) defects. METHODS: Fifty-nine patients with confirmed glaucoma were recruited at University Hospitals Leuven. Retinal oxygen saturation in patients with glaucoma was measured with a noninvasive spectrophotometric retinal oximeter (Oxymap ehf, Reykjavik, Iceland). VF and Heidelberg retinal tomographies (HRTs) were performed on the same day. Statistical analysis was performed using Student's t-test and Pearson's or Spearman correlation coefficient. RESULTS: The mean oxygen saturation in venules was higher in patients with severe VF defects compared to those patients with mild VF defects (69 ± 3% versus 65 ± 6% respectively; p = 0.0003; n = 59). Accordingly, the arteriovenous (AV) difference in oxygen saturation was lower in patients with worse VF compared to those with better VF (29 ± 3% versus 33 ± 6% respectively; p = 0.002). The oxygen saturation in venules correlated with the VF mean defects (r = -0.42; p = 0.001; n = 59) as well as with the structural HRT parameters rim area and RNFL thickness (r = -0.39; p = 0.008 and r = -0.26; p = 0.05 respectively; n = 53). The AV difference decreased significantly as the VF defect worsened (r = 0.38; p = 0.003), as the rim area diminished (r = 0.29; p = 0.03) and as the RNFL thickness decreased (r = 0.27; p = 0.05). No correlation was found between the oxygen saturation in retinal arterioles and either of these parameters. CONCLUSION: Severe glaucomatous damage is associated with increased oxygen saturation in retinal venules and decreased AV difference in oxygen saturation. These data suggest that in eyes with severe glaucomatous damage, reduced retinal oxygen consumption is consistent with tissue loss.

Trabeculectomy with or without anterior chamber maintainer and adjustable sutures.

PURPOSE: To assess the long-term outcomes of trabeculectomy using an anterior chamber maintainer and a combination of adjustable and releasable sutures compared with trabeculectomy using a viscoelastic and solely releasable sutures. METHODS: In a prospective, randomized, single-center study, 2 different trabeculectomy techniques were compared. One eye of each patient was randomly assigned to trabeculectomy with an anterior chamber maintainer and a combination of 2 adjustable and 2 releasable flap sutures (technique 1), whereas the other eye had trabeculectomy with viscoelastic and 2 releasable flap sutures (technique 2). The postoperative management was comparable in both groups except for the manipulation of the adjustable sutures. The main outcome measures were the postoperative intraocular pressure (IOP), the frequency of early postoperative complications and interventions, and the number of glaucoma medications. RESULTS: Thirty-two patients were included and had a follow-up of at least 18 months. The preoperative and postoperative IOP at 18 months was 22.1±8 and 13.3±2 mm Hg in the group using technique 1 and 22.7±7 and 13.3±3 mm Hg in the group using technique 2, respectively (mean±SD; P=0.18 for IOP reduction between both techniques). Early postoperative complications and interventions were infrequent and comparable in both techniques. The reduction in number of medications was not significantly different between the 2 groups (mean±SD from 2.4±1.0 to 0.4±0.8 in the group using technique 1 and from 2.3±1.0 to 0.2±0.5 in the group using technique 2; P=0.50). CONCLUSIONS: There is no significant difference in IOP reduction, in frequency of postoperative complications and interventions, or in reduction of medications between the 2 techniques.

Accuracy of matching optic discs with visual fields: the European Structure and Function Assessment Trial (ESAFAT).

PURPOSE: To determine the ability of ophthalmologists across Europe to match stereoscopic optic disc photographs to visual fields of varying severity. DESIGN: Evaluation and comparison of 2 diagnostic tests. PARTICIPANTS: A total of 109 of 260 invited ophthalmologists in 11 European countries. These had participated in the previous European Optic Disc Assessment Trial (EODAT), a trial on glaucoma diagnostic accuracy based on optic discs only. METHODS: Each participant matched stereo optic disc photographs of 40 healthy and 48 glaucomatous eyes to a visual field chosen from 4 options per disc. The 4 presented visual fields included the corresponding one and 3 other visual fields, varying in severity. The matching accuracy and any inaccuracy per disease severity were calculated. Classification accuracy (as glaucomatous or healthy) was compared with EODAT data. Duplicate slides allowed for the assessment of intraobserver agreement. MAIN OUTCOME MEASURES: Accuracy of matching optic discs with their corresponding visual field and of classifying them as healthy or glaucomatous; intraobserver agreement (κ). RESULTS: The overall accuracy of ophthalmologists for correctly matching stereoscopic optic disc photographs to their visual fields was 58.7%. When incorrectly matched, the observers generally overestimated the visual field severity (P<0.001), notably in eyes with early glaucoma. The intraobserver agreement was, on average, moderate (0.52). CONCLUSIONS: European ophthalmologists correctly matched stereoscopic optic disc photographs to their corresponding visual field in only approximately 59% of cases. In most mismatches, the clinicians overestimated the visual field damage.

The Heidelberg retina tomograph ancillary study to the European glaucoma prevention study: study design and baseline factors.

PURPOSE: To describe the study design and baseline factors of the Heidelberg Retina Tomograph ancillary study within the EGPS. Furthermore, to examine the relationship between HRT optic disc topographic measurements and baseline demographic and ocular factors. METHODS: Four hundred and eighty-nine ocular hypertensive participants were included. Each participant completed HRT imaging at least annually. The associations between HRT measurements and IOP, central corneal thickness (CCT), baseline photographic estimates of vertical CDR ratio (CDR), asymmetry between the two eyes in CDR ratio and baseline visual field indices were assessed using regression analysis. RESULTS: Associations between HRT measurements and vertical CDR by photographs were found for almost all stereometric optic disc parameters in both univariate and multivariate analysis. The strongest association was found between vertical CDR measurements and disc, cup and rim area; cup and rim volume, CDR area, linear CDR, mean and maximum cup depth and cup shape measure (all p < 0.0001). In multivariate analysis, pattern standard deviation (PSD) and HRT disc area had significant associations with several HRT optic disc measurements. Furthermore, CCT was significantly associated with reference height and the glaucoma probability score (GPS, outside normal limits). CONCLUSIONS: The EGPS is the first multicentre, placebo-controlled randomized clinical trial to use HRT for monitoring optic disc changes in participants with ocular hypertension. We found strong associations between stereophotographic vertical CDR estimates, HRT disc area, PSD and several HRT parameters. We found, furthermore, that the parameters reference height and GPS were significantly related to central corneal thickness.

Outcomes of different management options for malignant glaucoma: a retrospective study.

BACKGROUND: To assess the outcomes of the various medical and surgical treatment options for malignant glaucoma. METHODS: Design Retrospective, comparative case series. Participants Twenty-four eyes of 21 patients with malignant glaucoma. Intervention Nine eyes were treated medically. Twenty-one eyes underwent surgery, 15 of which had the full vitrectomy-(phaco)-iridectomy-zonulectomy procedure. Main outcome measures Intraocular pressure (IOP), best-corrected visual acuity (BCVA) and number of glaucoma medications were measured. RESULTS: The relapse rate was 100% after medical therapy, 75% after a Yag laser capsulotomy and a hyaloidotomy, 75% after a conventional vitrectomy and 66% after an anterior vitrectomy in combination with an iridectomy-zonulectomy. All patients who underwent a full vitrectomy combined with an iridectomy and a zonulectomy (and phacoemulsification if phakic) had postoperative relief of malignant glaucoma without relapse within the follow-up period. After this vitrectomy-tunnel technique, the IOP ranged from 10 to 22 mmHg (mean 16 mmHg) after a mean follow-up of 61 days. Mean BCVA improved by 5 Early Treatment Diabetic Retinopathy Study (ETDRS) lines, and mean number of glaucoma medications decreased from two to one. CONCLUSION: Complete vitrectomy combined with iridectomy and zonulectomy (and phacoemulsification, if applicable) most successfully managed aqueous misdirection syndrome in our retrospective case series.

Prevalence and correlates of self-reported nonadherence with eye drop treatment: the Belgian Compliance Study in Ophthalmology (BCSO).

PURPOSE: This study aimed to investigate (1) the prevalence of nonadherence with eye drop treatment; (2) selected correlates of nonadherence at the patient and health-care organization level; and (3) the diagnostic value of the ophthalmologists' ratings, using patients' self-reports as standard. METHODS: This cross-sectional multicenter survey used questionnaires for ophthalmologists and their patients to assess self-reported nonadherence and its correlates. One item, using a 4-point scale [never (ie, adherent) to daily], asked the patients whether they had forgotten to administer eye drops during the past 2 weeks. Ophthalmologists rated their patients as adherent or nonadherent. Nonadherence was also determined by combined methods, whereby either could indicate nonadherence. Given the nested structure of the data, multilevel modeling was used to investigate self-reported nonadherence-correlates. Diagnostic values of ophthalmologists' report were calculated. RESULTS: Of 663 patients (48% female, 44% >69 years), nonadherence was indicated in 39.2% (n=260) through self-reporting, 2.1% (n=14) through ophthalmologists' ratings, and 40% (n=266) through combined measures. The multivariable, multilevel model showed following significant nonadherence-correlates: Male sex (P=0.01), younger age (P=0.027), and higher-dose frequency (P=0.001). No significant correlation with treating ophthalmologist (P=0.21) could be seen. Yet, the patients visiting their ophthalmologists at least every 3 months were less nonadherent than patients with fewer consultations (P=0.01). The ophthalmologists' report showed a sensitivity and specificity of 3% and 98.5%, respectively. CONCLUSIONS: The prevalence of self-reported nonadherence was congruent with literature. The patients visiting their ophthalmologists at least every 3 months have a lower risk of nonadherence. Ophthalmologist report is an insensitive method for detecting nonadherence.

Agreement and accuracy of non-expert ophthalmologists in assessing glaucomatous changes in serial stereo optic disc photographs.

PURPOSE: To compare the interobserver agreement in detecting glaucomatous optic disc changes using serial stereophotography between a large group of non-expert ophthalmologists and glaucoma specialists; to assess the accuracy of non-experts; to investigate whether the interobserver agreement and the accuracy of non-experts changed after a training session. DESIGN: Masked interobserver agreement study. PARTICIPANTS: Serial optic disc stereophotos from 40 patients with glaucoma. METHODS: Three independent experienced glaucoma specialists (readers of the European Glaucoma Prevention Study) evaluated a set of 2 serial optic disc color stereo-slides for glaucomatous change, obtained with a delay varying from 2 to 7 years of 40 patients, masked from the temporal sequence of the slides. Each patient was graded as changed or stable by agreement of 2 of 3 of the experts (the reference standard). Thirty-seven non-expert ophthalmologists independently evaluated the same set of serial optic disc stereo-slides twice, with the second evaluation on the same day, masked from the results of the previous evaluation, after a training session on a separate slide set. MAIN OUTCOME MEASURES: Interobserver agreement of non-experts and experts in detecting glaucomatous optic disc changes (expressed as kappa coefficient); agreement of non-experts with the reference standard (accuracy) before and after a training session. RESULTS: The interobserver kappa coefficient (κ) of the non-experts and experts was 0.20 (95% confidence interval [CI], 0.19-0.21) and 0.51 (95% CI, 0.33-0.69), respectively (P<0.0001). The mean κ of the non-experts with the reference standard was 0.33 (95% CI, 0.27-0.39). After a training session, the interobserver agreement of the non-experts increased from 0.20 to 0.27 (95% CI, 0.26-0.28) (P<0.0001). The percentage agreement of the non-experts with the reference standard improved from 68.5% before to 71.4% after the training session (Wilcoxon signed-rank test, P=0.034). CONCLUSIONS: The interobserver agreement of non-expert ophthalmologists in detecting glaucomatous optic disc changes using serial stereophotos was significantly lower than that of experts, which was moderate. After a training session, the interobserver agreement and the accuracy of the non-experts showed a small but statistically significant improvement.

Comparison of ocular response analyzer, dynamic contour tonometer and Goldmann applanation tonometer.

The aim of this study was to compare the intra-ocular pressure (IOP) obtained by ocular response analyzer (ORA), dynamic contour tonometer (DCT) and Goldmann applanation tonometer (GAT). In 102 patients (47 with primary open-angle glaucoma and 55 healthy controls) IOP was measured with GAT, ORA and DCT in one eye. The agreement between GAT, DCT and ORA values was assessed using Bland-Altman plots. The discrepancy between the methods was related to central corneal thickness (CCT), corneal hysteresis (CH) and corneal resistance factor (CRF) using linear regression models. Significant differences were observed amongst DCT, corneal compensated ORA (ORAcc) and GAT (P < 0.01). Only the ORAcc and DCT were comparable. ORAcc and DCT significantly over-estimated IOP compared to GAT and for ORAcc this difference depended on the height of IOP. A significant correlation was found between CCT and the deviation of DCT and ORAcc from corrected GAT (both P < 0.0001). Our study showed a low degree of agreement between IOP measured by ORA, DCT and GAT. DCT and ORAcc over-estimated the IOP compared to GAT.

Preoperative nonsteroidal anti-inflammatory drug or steroid and outcomes after trabeculectomy: a randomized controlled trial.

PURPOSE: To investigate the benefit of preoperative treatment with either topical nonsteroidal anti-inflammatory drug (NSAID) or steroid in terms of clinical outcomes following trabeculectomy. DESIGN: Prospective, randomized placebo-controlled trial. PARTICIPANTS: Sixty-one patients. METHODS: Between July 2005 and October 2007, 61 consecutive medically uncontrolled glaucoma patients scheduled for first-time trabeculectomy were randomized to 1 of 3 study topical medication groups: nonsteroidal anti-inflammatory drugs (ketorolac), steroids (fluorometholone), or placebo (artificial tears). Patients instilled 1 drop 4 times daily for 1 month before the procedure and were examined on days 1 and 2, at weeks 1, 2, and 4, and at months 3, 6, 12, 18, and 24 after trabeculectomy. MAIN OUTCOME MEASURES: Incidence of postoperative surgical or medical interventions (needling, laser suture lysis, needling revision, and intraocular pressure [IOP]-lowering medication). RESULTS: Fifty-four patients (54 eyes) were entered for analysis. The mean number of preoperative medications was 2.3+/-0.9. The mean baseline IOP was 21.0+/-6.0 mmHg. The mean postoperative target IOP was 16.5+/-1.8 mmHg. The mean follow-up was 23.6+/-4.0 months. The percentage of patients requiring needling within the first year was 41% in the placebo group, 6% in the NSAID, and 5% in the steroid group (P = 0.006). The percentage of patients requiring IOP-lowering medication to reach the target IOP at 1 year was 24% in the placebo group, 18% in the NSAID group, and 0% in the steroid group (P = 0.054 overall; P = 0.038 for steroids vs. others). The log-rank test showed a significant (P = 0.019) difference in medication-free survival curves between the different groups. More specifically, patients in the steroid group needed significantly less medication over the total follow-up (P = 0.007). CONCLUSIONS: Topical ketorolac or fluorometholone for 1 month before surgery was associated with improved trabeculectomy outcomes in terms of likelihood of postoperative needling. In the steroid group, there was a significantly reduced need for additional postoperative IOP-lowering medication compared with the other groups. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Clinical assessment of stereoscopic optic disc photographs for glaucoma: the European Optic Disc Assessment Trial.

PURPOSE: To determine the diagnostic accuracy of judging optic disc photographs for glaucoma by ophthalmologists. DESIGN: Evaluation of diagnostic test and technology. PARTICIPANTS: A total of 243 of 875 invited ophthalmologists in 11 European countries. METHODS: We determined how well each participant classified 40 healthy eyes and 48 glaucomatous eyes with varying severity of the disease on stereoscopic slides. Duplicate slides were provided for determining intraobserver agreement. All eyes were also imaged with the GDx with variable corneal compensation (GDx-VCC) (Carl Zeiss Meditec AG, Jena, Germany) and the Heidelberg Retina Tomograph (HRT) I (Heidelberg Engineering GmbH, Heidelberg, Germany). Diagnostic accuracies of clinicians were compared with those of the best machine classifiers. MAIN OUTCOME MEASURES: Accuracy of classification, expressed as sensitivity, specificity, and overall accuracy. Intraobserver agreement (kappa). RESULTS: The overall diagnostic accuracy of ophthalmologists was 80.5% (standard deviation [SD], 6.8; range, 61.4%-94.3%). The machine classifiers outperformed most observers in diagnostic accuracy; the GDx-VCC nerve fiber indicator and the HRT's best classifier correctly classified 93.2% and 89.8% of eyes, respectively. The intraobserver agreement (kappa) varied between -0.13 and 1.0 and was on average good (0.7). CONCLUSIONS: In general, ophthalmologists classify optic disc photographs moderately well for detecting glaucoma. There is, however, large variability in diagnostic accuracy among and agreement within clinicians. Common imaging devices outperform most clinicians in classifying optic discs. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

The effect of trabeculectomy on ocular pulse amplitude.

PURPOSE: To investigate whether trabeculectomy, besides its intraocular pressure (IOP)-lowering effect, has an effect on ocular pulse amplitude (OPA); and to determine whether OPA changes are influenced by IOP changes. METHODS: Forty-eight patients with glaucoma (48 eyes) scheduled for unilateral first-time trabeculectomy were prospectively enrolled from October 2007 to April 2008. The eye undergoing trabeculectomy was considered the study eye, whereas the nonsurgical fellow eye was used as the control eye. OPA, IOP, blood pressure, and heart rate were measured before and 4 weeks after trabeculectomy by means of Pascal dynamic contour tonometry (DCT), Goldmann applanation tonometry (GAT), and sphygmomanometry. A regression model for repeated measures was used. RESULTS: Preoperative GAT, DCT, and OPA were 20.92 +/- 8.55, 21.33 +/- 7.06, and 3.23 +/- 1.58 mm Hg, respectively. One month after trabeculectomy, GAT, DCT, and OPA were 11.23 +/- 5.03, 14.45 +/- 4.79, and 2.12 +/- 1.07 mm Hg, respectively. There was a significant decrease in OPA after filtration surgery in the study eye compared with the control eye (P < 0.0001). Changes in OPA were correlated with changes in IOP (Spearman rho = 0.49, P = 0.0004). When the IOP change caused by filtration surgery was taken into account, no significant difference in effect on OPA after trabeculectomy was demonstrated in the study eye compared with the control eye (P = 0.18). CONCLUSIONS: OPA changes correlated strongly with IOP changes. There was no evidence of an effect of filtration surgery on OPA when the concomitant IOP decrease after trabeculectomy was taken into account.

Comparison of ICare, dynamic contour tonometer, and ocular response analyzer with Goldmann applanation tonometer in patients with glaucoma.

PURPOSE: To compare the intraocular pressure (IOP) readings taken by ICare, Pascal dynamic contour tonometer (DCT), and ocular response analyzer (ORA) with those taken by Goldmann applanation tonometer (GAT). We sought to evaluate the influence of central corneal thickness (CCT) on IOP measurements and to compare patients' preferences for the four tonometers. METHODS: In this prospective study, 93 eyes from 93 patients were examined. Patients were randomly divided into 4 groups to vary the order in which the tonometers were applied. CCT was measured with an ultrasound pachymeter. RESULTS: The average CCT was 558+/-47.4 microm. The mean +/- standard deviation IOP for GAT, ICare, DCT, and ORA (Goldmann-correlated IOP) (ORA(GC)) were 15.1+/-4.8, 15.7+/-5.7, 18.2+/-5.1, and 18.3+/-6.6 mmHg, respectively. There was no significant difference between the mean IOP obtained with GAT and ICare (p=0.14). There was also no difference in IOP levels between the mean IOP obtained with DCT and ORA (p=0.26). There was no correlation between IOP measurements and CCT for the 4 instruments. Bland-Altman graphs showed disagreement between the measurements taken by GAT and the other instruments. There was no significant difference in patients' preference among the 4 instruments (p=0.48). CONCLUSIONS: IOP readings from ICare were consistent with those from GAT, whereas DCT readings correspond well to ORA(GC) measurements. DCT and ORA readings both overestimated the GAT readings. There was no correlation between the IOP measurements and the CCT for the 4 instruments. There was no significant difference in patients' preference among the 4 instruments.

Reproducibility of color Doppler imaging.

PURPOSE: The aims of this study were: (1) to determine the intra-subject and inter-observer variability of color Doppler imaging (CDI) measurements and readings of the retrobulbar blood vessels, (2) to compare the difference invariability of CDI parameters in non-glaucomatous controls versus glaucoma patients, and (3) to provide calculations of minimum sample sizes for future CDI studies. METHODS: Patients with normal tension glaucoma (n=28), primary open-angle glaucoma (n=19) and non-glaucomatous controls of comparable age (n=22) underwent CDI on two occasions 1 month apart. Variability in CDI parameters was quantified using (within-subject) coefficients of variation. Based on this variability, minimum sample sizes were calculated to guide the design of future studies comparing CDI between and within groups. RESULTS: In general, within-subject coefficients of variation for measurements 1 month apart were comparable to previously reported short-term variations. Variability was higher in glaucoma patients than in non-glaucomatous controls. The minimum sample size required for glaucomatous study populations is larger than for non-glaucomatous controls. Smaller patient groups are required to detect change using the peak systolic blood flow velocities than using end diastolic velocities. Studies using a cross-over design require smaller sample sizes than studies with a prepost or particularly parallel design. CONCLUSIONS: This study provides extensive information on long-term intra-subject variability of CDI measurements in non-glaucomatous controls as well as glaucoma patients. Moreover, sample size calculations are provided for studies involving glaucoma patients as well as non-glaucomatous individuals, using three different commonly used study designs.