Hydrus microstent compared to selective laser trabeculoplasty in primary open angle glaucoma: one year results.

BACKGROUND: To compare the reduction of intraocular pressure (IOP) and glaucoma medications following selective laser trabeculoplasty (SLT) versus stand-alone placement of the Hydrus microstent, a microinvasive glaucoma surgery device. DESIGN: Prospective interventional case-series. University practice. PARTICIPANTS: Fifty six eyes (56 patients) with uncontrolled primary open-angle glaucoma. METHODS: Patients received either SLT (n = 25) or Hydrus implantation (n = 31) in two centres. Patients were evaluated at baseline and 1, 7 days, 1, 3, 6 and 12 months after surgery. MAIN OUTCOME MEASURES: Intraocular pressure and number of glaucoma medications variations inter-groups and intra-groups. RESULTS: There were no significant differences at baseline between groups, but the mean deviation was worse in the Hydrus group (-8.43 ± 6.84 dB, confidence limits (CL)-2.8/-3.3 vs.-3.04 ± 0.65 dB, CL-6/-10.8; P < 0.001). After 12 months, there was a significant decrease in IOP and medications in the Hydrus group compared with baseline values. In the SLT group, only the decrease in IOP was significant. There was 3-fold greater reduction in medication use in the Hydrus group compared with SLT (-1.4 ± 0.97 vs.-0.5 ± 1.05, P = 0.001). 47% of patients were medication free at 12 months in the Hydrus group (4% in the SLT group). No complications were recorded in the SLT group. In the Hydrus group, three patients experienced a temporary reduction of visual acuity post-operatively, and two patients had post-operative IOP spikes that resolved within one week. CONCLUSIONS: Both SLT and Hydrus implantation reduced IOP without serious adverse events. Hydrus implantation led to a significant and further reduction in medication dependence at 12 months.

Blindness and Glaucoma: A Multicenter Data Review from 7 Academic Eye Clinics.

PURPOSE: To evaluate frequency, conversion rate, and risk factors for blindness in glaucoma patients treated in European Universities. METHODS: This multicenter retrospective study included 2402 consecutive patients with glaucoma in at least one eye. Medical charts were inspected and patients were divided into those blind and the remainder ('controls'). Blindness was defined as visual acuity≤0.05 and/or visual field loss to less than 10°. RESULTS: Unilateral and bilateral blindness were respectively 11.0% and 1.6% at the beginning, and 15.5% and 3.6% at the end of the observation period (7.5±5.5 years, range:1-25 years); conversion to blindness (at least unilateral) was 1.1%/year. 134 eyes (97 patients) developed blindness by POAG during the study. At the first access to study centre, they had mean deviation (MD) of -17.1±8.3 dB and treated intraocular pressure (IOP) of 17.1±6.6 mmHg. During follow-up the IOP decreased by 14% in these eyes but MD deteriorated by 1.1±3.5 dB/year, which was 5-fold higher than controls (0.2±1.6 dB/year). In a multivariate model, the best predictors for blindness by glaucoma were initial MD (p<0.001), initial IOP (p<0.001), older age at the beginning of follow-up (p<0.001), whereas final IOP was found to be protective (p<0.05). CONCLUSIONS: In this series of patients, blindness occurred in about 20%. Blindness by glaucoma had 2 characteristics: late diagnosis and/or late referral, and progression of the disease despite in most cases IOP was within the range of normality and target IOP was achieved; it could be predicted by high initial MD, high initial IOP, and old age.

Repeatability and reproducibility of applanation resonance tonometry: a cross-sectional study.

BACKGROUND: To assess repeatability (intra-observer variability) and reproducibility (inter-operator variability) of intraocular pressure (IOP) measurements with servo-controlled Bioresonator Applanation Resonance Tonometry (ART) and to evaluate possible influential factors. METHODS: The study included 178 patients (115 glaucoma and 63 controls; one eye per subject). IOP was measured once with a Goldmann applanation tonometer (GAT) and twice by ART (ART1, ART2), in randomized sequence, by a single operator to assess intra-operator variability. Each ART measurement consisted on 3 readings. To assess inter-operator variability 2 evaluators performed 2 measurements each (in random order) on the same patient. Repeatability and reproducibility were assessed by the coefficient of variation (CoV) and intraclass correlation coefficient (ICC). RESULTS: In the entire cohort, ART1 was 0.4 ± 2.2 mmHg (-7.0 to 5.7 mmHg) higher than ART2 (p = 0.03) regardless of test order. Intra-operator CoV was 7.0% ± 6.3%, and ICC was 0.80-0.92. Inter-operator CoV ranged between 5.7% ± 6.1% and 8.2% ± 7.2%, and ICC between 0.86 and 0.97. ART1 and 2 were respectively 1.7 ± 3.1 and 1.3 ± 3.1 mmHg higher than GAT (p < 0.01). Test-retest difference with ART fell within ±1 mmHg in 41% of cases, within ±2 mmHg in 70%, within ±3 mmHg in 85%. 15% had a test-retest difference higher than ± 3 mmHg; Bland-Altman 95% intervals of confidence were -3.9 and +4.6 mmHg. Results were unaffected by age, diagnosis, central corneal thickness, keratometry, operator, randomization sequence. CONCLUSIONS: In most cases ART repeatability and reproducibility were high, with no differences due to patients' characteristics. ART measurements overestimated GAT by a mean of 1.3-1.7 mmHg.

Circadian intraocular pressure patterns in healthy subjects, primary open angle and normal tension glaucoma patients with a contact lens sensor.

PURPOSE: To examine the circadian intraocular pressure (IOP) patterns in healthy subjects, in primary open angle and normal tension glaucoma (POAG; NTG) using a contact lens sensor (CLS; Sensimed Triggerfish, Lausanne, Switzerland). METHODS: This was an observational, nonrandomized study. Ten healthy subjects (Group 1, 10 eyes) and 20 glaucomatous patients [20 eyes, 10 with POAG (Group 2) and 10 with NTG (Group 3)] were enrolled. All patients were controlled with prostaglandin analogues. The 24-hr IOP pattern was the main outcome. The morning (6AM-11AM), afternoon/evening (noon-11PM) and night (midnight-5AM) subperiod patterns, peaks and prolonged peaks (>1 hr) were secondary outcomes. RESULTS: Mean 24-hr IOP pattern showed a nocturnal acrophase in all groups. Patterns were significantly different among groups (p = 0.02), with highest nocturnal IOP values in POAG. Prolonged peaks were more common in patients with glaucoma (70%) than in healthy subjects (33.3%) (p < 0.001). Significant differences were found for Groups 2 and 3 in the morning versus afternoon/evening (p = 0.019 and p = 0.035, Bonferroni correction), morning versus night (p = 0.005 and p < 0.0001) and afternoon/evening versus night periods comparisons (p < 0.0001 for both groups). In Group 1, patterns significantly differed in the morning versus night and afternoon/evening versus night period comparisons (p < 0.0001). CONCLUSIONS: Continuous 24-hr IOP monitoring with the CLS revealed a nocturnal acrophase in healthy subjects and, more markedly, in glaucoma. Because the diurnal IOP profile seems not to predict the nocturnal rhythm, the circadian IOP pattern should be evaluated in clinical practice. These findings may be worthwhile for the management of glaucoma.

Structural and functional brain changes beyond visual system in patients with advanced glaucoma.

In order to test the hypothesis that in primary open angle glaucoma (POAG), an important cause of irreversible blindness, a spreading of neurodegeneration occurs through the brain, we performed multimodal MRI and subsequent whole-brain explorative voxelwise analyses in 13 advanced POAG patients and 12 age-matched normal controls (NC). Altered integrity (decreased fractional anisotropy or increased diffusivities) of white matter (WM) tracts was found not only along the visual pathway of POAG but also in nonvisual WM tracts (superior longitudinal fascicle, anterior thalamic radiation, corticospinal tract, middle cerebellar peduncle). POAG patients also showed brain atrophy in both visual cortex and other distant grey matter (GM) regions (frontoparietal cortex, hippocampi and cerebellar cortex), decreased functional connectivity (FC) in visual, working memory and dorsal attention networks and increased FC in visual and executive networks. In POAG, abnormalities in structure and FC within and outside visual system correlated with visual field parameters in the poorer performing eyes, thus emphasizing their clinical relevance. Altogether, this represents evidence that a vision disorder such as POAG can be considered a widespread neurodegenerative condition.

Ocular surface changes in glaucomatous patients treated with and without preservatives beta-blockers.

PURPOSE: To determine whether there were ocular surface changes in glaucomatous patients treated with preservatives beta-blockers who switched to preservative-free beta-blockers. METHODS: This was a prospective, longitudinal, open-labeled study. One hundred thirty-two patients with primary open angle glaucoma treated with a preserved beta-blocker were enrolled. All the patients underwent perimetric and gonioscopic examination, complete ophthalmologic examination, intraocular pressure (IOP) measurements, evaluation of ocular surface, Schirmer's test, blood pressure and heart rate at baseline and 1-3 months after changing the medical treatment to a preservative-free timolol 0.1% (Timogel 0.1; Thea). At baseline, after 1 month and at the end of the study (3 months), all patients underwent a questionnaire on the visual quality and symptoms and on the quality of life (QoL). Data were analyzed by t-test when the distribution of the data was normal, by Mann-Whitney when the distribution was not normal. RESULTS: No significant difference was found for IOP before switching from preserved beta-blockers to preservative-free ones. No significant difference was found in blood pressure and heart rate. However, a statistically significant difference was found for abnormal fluorescein staining of the cornea and conjunctiva, eyelid erythema, conjunctival hyperemia, and follicular hyperplasia. A significant difference was found for break-up time (from 9.38±4.7 s at baseline to 10.64±4.7 s after 3 months) and Schirmer's test (from 12.9±5.96 mm at baseline to 14.2±5.87 mm after 3 months). The questionnaire showed that the patient improved the dryness and foreign body sensation. CONCLUSION: In glaucomatous patients, preservative-free 0.1 timolol treatment improved their QoL. Similar dry eye signs or symptoms improved after 3 months of treatment reducing dryness, hyperemia, follicular hyperplasia, and foreign body sensation.

In vivo confocal microscopy of conjunctiva in preservative-free timolol 0.1% gel formulation therapy for glaucoma.

PURPOSE: To evaluate the effects at 1 year of preservative-free timolol gel and preserved timolol eye drops on conjunctiva and tear parameters. METHODS: Forty patients with primary open-angle glaucoma or ocular hypertension were randomized to the two treatment groups and compared with 20 healthy age-matched controls. Clinical tests (IOP, Schirmer I test, and lacrimal film break-up time BUT) and in vivo conjunctival confocal microscopy (IVCM) were performed in all patients at baseline and after 12 months. IVCM (HRT II Rostock Cornea Module; Heidelberg Engineering GmbH, Heidelberg, Germany) was performed after topical anaesthesia in the four cardinal locations and at the corresponding limbus to analyse conjunctiva cells. The main IVCM outcomes were goblet cell density and epithelial regularity. RESULTS: IVCM and clinical parameters were similar in the three groups at baseline. After 12 months, intra-epithelial goblet cell density was significantly lower in the preserved (48.25 ± 7.70) than in the preservative-free beta-blocker group (86.83 ± 22.17, p < 0.001) and controls (88.9 ± 18.33, p < 0.001). The epithelial layer was significantly more regular in the preserved beta-blocker medication group than in the preservative-free beta-blocker group (p < 0.001) and the control group (p < 0.001). A significant reduction in both Schirmer I and BUT was found in the group of preserved timolol (respectively, 11.3 ± 2.97 and 8.12 ± 0.99) compared with preservative-free timolol (16.8 ± 1.83 and 11.27 ± 1.27, p < 0.001) and controls (17.8 ± 1.87 and 12.10 ± 1.28, p < 0.001). CONCLUSIONS: Based on our IVCM data, preservative-free beta-blocker gel induces less changes at ocular surface than preserved beta-blockers, a fact that should be considered to obtain less adverse effects and maximal adherence to treatment in a chronic condition such as glaucoma.

Phacoemulsificator and sterile drapes contamination during cataract surgery: a microbiological study.

PURPOSE: To determine the microbial contamination of the irrigating fluids at the time of phacoemulsification after the use of topical povidone-iodine and antibiotics prophylaxis. METHODS: A total of 119 patients undergoing cataract surgery were enrolled in this prospective study. All patients received 5 mg/mL levofloxacin starting from the day prior to surgery and topical and 5% povidone-iodine drops starting from 30 minutes before the surgery. At the end of each surgery, 2 samples of drainage liquids were sterilely collected from the drainage bags (DBL) and from the peristaltic pump single-cassettes (PCL) of the phacoemulsification machine. Search for aerobic and anaerobic bacteria and fungi was performed. RESULTS: Seventy-five patients (31.5%) revealed a growth of at least one microbial species (53 DBL and 22 PCL, 44.5% vs 18.5%; p<0.001). Sixty-six patients (55.5%) had at least one positive intraoperative solution. Overall, 111 microbial strains were collected: 82 (74%) Gram-positive bacteria, 20 (18%) fungi, and 9 (8%) Gram-negative bacteria. Thirteen staphylococcal isolates from PCL, compared with 52 out of DBL (11% vs 43.7%, p<0.001), fungi were essentially isolated from PCL. No significant correlation was found between microbial isolation and risk factors. No postsurgical infective complication occurred in the follow-up. CONCLUSIONS: Evaluation of intraoperative fluids can provide evidence on sources or vehicles of postsurgical infections. Antibiotic prophylaxis and topical povidone-iodine can significantly contribute to minimize the risk of endophthalmitis.

Association between primary open-angle glaucoma (POAG) and WDR36 sequence variance in Italian families affected by POAG.

BACKGROUND/AIMS: To assess the involvement of WDR36 sequence variance in primary open-angle glaucoma (POAG) in Italian patients. METHODS: A cohort of 34 Italian families affected by POAG was analysed by denaturing high-performance liquid chromatography for mutation in the WDR36 gene. Among the 34 families enrolled, 25 were affected by high-tension glaucoma (HTG), four by juvenile open-angle glaucoma and one by normal tension glaucoma. In addition, four families presented both juvenile open-angle glaucoma and HTG-POAG patients within the same pedigree. RESULTS: Four previously identified intronic polymorphisms (IVS5+30C→T; IVS12+90 G→T; IVS13+89G→A; IVS16-30A→G) and a novel one (IVS21-75G→A) have been identified. In addition, one proband was found to carry the p.D658G mutation reported as the more recurrent disease-causing allele. CONCLUSIONS: The findings suggest that WDR36 sequence variance is only a rare cause of glaucoma in Italian families. Clearly, investigation of additional families with extensive studies is needed to clarify the role of WDR36 in the pathophysiology of glaucoma.

Pseudophakic eye globe disruption.

PURPOSE: Scleral rupture due to bulb bursting can result from a heavy contusion. Owing to refined surgical techniques and the use of antibiotics and cortisone-based medication, more conservative concepts have followed. In major ruptures, the results were almost always very poor, with atrophy or subatrophy of the eyes. METHODS: A 63-year-old man with major left ocular trauma and intraocular lens dislocation in the subconjunctival area was referred to the authors for clinical and surgical evaluation. RESULTS: Surgery was performed 3 weeks after the trauma to allow for improvement in the patient's condition. The reabsorption of a palpebral-frontal hematoma, which made bulb exploration almost impossible, was fundamental in order to proceed. After 1 year, the best-corrected visual acuity was 0.9. In fact, great improvements in surgical techniques in recent years have allowed us to consider the problem of major rupture in a new way, both technically and from an organizational point of view. CONCLUSIONS: In terms of organization, the concept of urgent surgical procedures must be reevaluated, because besides traumatic damage, incomplete surgical measures may result. This makes all treatment useless, in both barely equipped and highly specialized centers.

Use of amniotic membrane transplantation in isolated conjunctival Bowen disease: a case report.

PURPOSE: To report a case of isolated conjunctival Bowen disease treated with surgical resection and amniotic membrane transplantation. METHODS: Interventional case report. RESULTS: A 70-year-old man was admitted to our clinic with a large conjunctival verrucous plaque well-demarcated in the correspondence of the bulbar conjunctiva in the superior quadrant of the left eye with involved limbal and corneal surface. Ophthalmologic examination on slit-lamp examination and color fundus photographs were carried out before surgery and the results were evaluated. CONCLUSIONS: Treatment options and treatment studies of Bowen disease are difficult because there are a variety of different protocols and the success of the management depends on several factors (body site, lesion size, number of lesions, and thickness). In the conjunctival localization of the lesion, amniotic membrane transplantation appears to be a useful therapeutic choice after surgical resection of the lesion used to reconstruct ocular and conjunctival surface.

Longterm follow-up of diode laser transscleral cyclophotocoagulation in the treatment of refractory glaucoma.

PURPOSE: This prospective study was conducted to evaluate the efficacy and safety of transscleral diode laser cyclophotocoagulation (TDLCP) in advanced refractory glaucoma. METHODS: A total of 124 eyes in 121 patients with advanced glaucoma refractory to medical treatment were treated consecutively with TDLCP. Success was defined as final intraocular pressure (IOP) of 5-21 mmHg in eyes with visual acuity (VA) of more than hand movements (HM) and relief of pain in eyes with VA of HM or less, including blind eyes. RESULTS: Mean patient age was 65.6 +/- 17.1 years (range 14-91 years). Mean follow-up was 17 +/- 14.6 months (range 3-42 months). Mean pretreatment IOP was 29.9 +/- 8.4 mmHg (range 17-58 mmHg) and IOP at last follow-up was 20.8 +/- 8 mmHg (range 6-45 mmHg) (p < 0.001). The number of laser applications (mean 9.2 +/- 2.8, range 4-15) and maximal laser power (mean 2.01 +/- 0.22 mW, range 1.3-3.0 mW) were not associated with lower postoperative IOP. Intraocular pressure of < or = 21 mmHg was recorded in 63.0% of eyes at the last follow-up visit. Overall, 28 (21.7%) eyes required at least one retreatment. No phthisis bulbi or persistent hypotonia developed. CONCLUSIONS: TDLCP is an effective and safe method for the treatment of advanced refractory glaucoma, although repeated treatments are often necessary.

An in vivo confocal microscopy analysis of effects of topical antiglaucoma therapy with preservative on corneal innervation and morphology.

PURPOSE: To evaluate the long-term effects of preservative-free and preservative-containing antiglaucoma eye drops on the tear secretion and ocular surface. DESIGN: Comparative retrospective study. METHODS: A total of 84 patients with bilateral primary open-angle glaucoma or ocular hypertension divided into 5 groups according to type of topical hypotensive therapy and 20 healthy age-matched volunteers were studied. Clinical tests (corneal sensitivity, Schirmer I test, and lachrymal film break-up time), and in vivo confocal microscopy were performed in all patients. RESULTS: A significant reduction of the scores was found between groups on topical hypotensive therapy and the control group in all clinical parameters studied (P < .05). In particular, the clinical scores were significantly lower in the preservative medication groups than in the preservative-free group (P < .05). The density of superficial epithelial cells was reduced in all glaucomatous patients, except for the preservative-free group (P > .05), with respect to control subjects (P < .001). On the contrary, the density of basal epithelial cells of glaucomatous preservative therapy groups was higher than control and preservative-free groups (P < .05). Stromal keratocyte activation and the number of beads were higher in all glaucoma preservative groups (P < .05). The number of sub-basal nerves was lower in all glaucoma groups than in the control group (P < .05) and tortuosity was significantly higher in glaucoma than control groups (P < .05). Reflectivity of fibers did not show any significant difference between the 6 groups (P < .05). CONCLUSIONS: Glaucomatous patients with chronic treatment show ocular surface alterations. The development of nontoxic antiglaucoma treatment may reduce damage to the ocular surface and improve the compliance and the adherence in the medical therapy.