European Journal of Ophthalmology

To evaluate the intraocular pressure (IOP)-lowering effects and tolerability of the 3 prostaglandin-timolol fixed combinations (PG-timolol FCs).

Clinical trials comparing directly the PG-timolol FCs or comparing the PG-timolol FCs to their individual components were thoroughly searched. The main outcome measures were efficacy assessed by IOP (taken at 9 AM, noon, 4 PM, and over the mean diurnal curve) change at 3 months (or after 1 to 6 months of treatment if no data were available at month 3) from baseline and tolerability assessed by the incidence of conjunctival hyperemia.

Twenty trials were identified (n=4684 patients). Intraocular pressure reduction was usually greater with the 3 PG-timolol FCs than the individual PG (mean difference [MD] 0.00 mmHg to 2.59 mmHg; p>0.1 to p<0.001). The incidence of hyperemia was significantly less with latanoprost- and bimatoprost-timolol FCs than with the individual PG (relative risk = 0.66 and 0.61; p=0.05 and p<0.001). From direct comparisons, IOP reduction was significantly greatest with bimatoprost-timolol FC, at 9 AM, 4 PM, and over the mean diurnal curve compared to latanoprost-timolol FC (MD = 0.90 mmHg to 1.48 mmHg; p<0.001) and at all time points compared to travoprost-timolol FC (MD = 0.66 mmHg to 0.90 mmHg; p<0.001). The incidence of hyperemia was not significantly less with latanoprost-timolol FC than with bimatoprost-timolol FC (relative risk = 1.32; p>0.1).

The 3 PG-timolol FCs provide a greater IOP reduction and lower incidence of hyperemia than the 3 PGs alone. The direct comparisons suggest a greater efficacy of the bimatoprost-timolol FC compared with latanoprost- and travoprost-timolol FCs.

To determine if a test formulation of latanoprost 0.005% (Bausch & Lomb) eyedrops reduced intraocular pressure (IOP) as well as Xalatan® (latanoprost 0.005%) in patients with ocular hypertension (OH) or primary open-angle glaucoma (POAG).

This multicenter, randomized, investigator-masked, parallel-group study allocated 266 patients with OH or POAG in a 1:1 ratio to latanoprost or Xalatan administered once daily for 6 weeks. The primary endpoint was the mean change in 8:00 AM IOP of the study eye from baseline to week 6. Secondary endpoints included mean change in 8:00 AM IOP from baseline to week 2, and in 12:00 noon and 4:00 PM IOP from baseline to week 2 and week 6. The safety and tolerability of both drugs were also assessed.

Both study groups had comparable demographics and baseline characteristics. The mean (SD) change in 8:00 AM IOP from baseline to week 6 was −7.29 (2.61) and −7.54 (2.80) mmHg with latanoprost and Xalatan, respectively. Latanoprost was found noninferior to Xalatan in the primary analysis (mean [SEM] treatment difference, 0.252 [0.504] mmHg; 95% confidence interval [CI] −0.408, 0.913; p = 0.0001; noninferiority margin, 1.5 mmHg) and met the predefined definition of equivalence to Xalatan (95% CI within [–1.5, 1.5 mmHg] margin). The IOP-lowering effects of latanoprost and Xalatan were comparable at all assessed time points. Both study treatments demonstrated a comparable safety and tolerability profile.

Bausch & Lomb latanoprost 0.005% is clinically equivalent to Xalatan for treating OH and POAG as demonstrated through this unique comparative trial.

To evaluate the efficacy, safety, and tolerability of Timogel® preservative-free once daily compared to timolol 0.5% ophthalmic solution bid in patients with ocular hypertension (OHT) and patients with primary open-angle glaucoma (POAG).

A total of 75 patients with OHT and patients with POAG treated with timolol 0.5% bid with intraocular pressure (IOP) ≤21 mmHg were enrolled. They underwent complete ophthalmologic examination, IOP measurements (at trough and daytime curve), evaluation of side effects, Schirmer test, break-up time [BUT], blood pressure, heart rate, ocular diastolic perfusion pressure measurements, and acceptance (Comparison of Ophthalmic Medications for Tolerability). Patients switched to Timogel® and were re-evaluated 3 months later. The analysis of variance and the Pearson χ² tests were used to test differences between the treatments.

Intraocular pressure reduction at trough was 23.6% with timolol 0.5% and 22.3% with Timogel®. No statistical differences were observed in IOP values at trough and in the daytime curve between the 2 treatments. Local and systemic side effects were less frequent with Timogel® (hazard ratio: p<0.05). Patients demonstrated a significant improvement of Schirmer test and BUT (p<0.05) and a reduction of dryness and foreign body sensation (42.6% vs 15.4%; p<0.01) after switching to Timogel®. Mild and short-lasting blurred vision after Timogel® instillation occurred in about 18.5% of patients. A total of 82% of patients were satisfied or very satisfied with Timogel® vs 61% with previous treatment (p<0.01).

Timogel® preservative-free dosed once every morning has a 24-hour hypotensive effect with a better safety profile than timolol 0.5% bid and it is well-accepted by patients. The once-daily dosing improved acceptance and compliance.

To demonstrate that the intraocular pressure (IOP)–lowering effect of travoprost 0.004% preserved with polyquaternium-1 (travoprost benzalkonium chloride [BAK]-free) is non-inferior to that of travoprost 0.004% preserved with benzalkonium chloride (travoprost BAK) in patients with ocular hypertension or open-angle glaucoma.

A total of 371 patients randomly received travoprost BAK-free (n=185) or travoprost BAK (n=186) dosed once daily in the evening for 3 months. Patients were evaluated at 9 AM, 11 AM, and 4 PM at baseline, weeks 2 and 6, and month 3. Intraocular pressure was also evaluated 36 and 60 hours after the month 3 visit.

Travoprost BAK-free is non-inferior to travoprost BAK. The 95% upper confidence limits for the difference in mean IOP at month 3 (primary efficacy) were 0.5 mmHg, 0.6 mmHg, and 0.5 mmHg, at 9 AM, 11 AM, and 4 PM, respectively. Mean IOP reductions from baseline ranged from 7.6 to 8.7 mmHg in the travoprost BAK-free group and from 7.7 to 9.2 mmHg in the travoprost BAK group. At 36 and 60 hours after the last dose, mean IOP remained 6.8 mmHg and 5.7 mmHg below baseline in the travoprost BAK-free group, vs 7.3 mmHg and 6.0 mmHg in the travoprost BAK group, respectively. The safety profile of travoprost BAK-free was similar to that of travoprost BAK.

Travoprost BAK-free safely and effectively lowers IOP in eyes with open-angle glaucoma or ocular hypertension. This BAK-free formulation has comparable safety, efficacy, and duration of IOP-lowering effect to travoprost preserved with BAK. Travoprost BAK-free is an effective option for IOP reduction while avoiding BAK exposure.

To compare sensitivity and specificity of retinal nerve fiber layer thickness (RNFLT) measurements made using RTVue-100 Fourier-domain optical coherence tomography (RTVue-OCT) and scanning laser polarimetry with variable (GDx-VCC) or enhanced compensation (GDx-ECC).

One eye of each of 177 consecutive patients was imaged. Healthy (n=50) and ocular hypertensive (n=28) eyes were defined as structurally undamaged, preperimetric (n=33) and perimetric (n=66) glaucoma eyes as diseased.

For average RNFLT, sensitivity was higher (χ² test, p=0.002) with RTVue-OCT (65.7%) than with GDx-VCC (49.5%). For superior and inferior RNFLT, sensitivity was similar with all methods. For the different nerve fiber bundle parameters, sensitivity of RTVue-OCT (64.6% to 84.8%) was consistently up to 35% higher (p<0.001) than that of GDx-VCC/ECC (28.3% to 72.7%). Specificity ranged from 84.6% to 98.7% with RTVue-OCT, 92.3% to 100% with GDx-VCC, and 94.9% to 100% with GDx-ECC, with no significant difference between the methods except for one nerve fiber bundle parameter, for which RTVue-OCT was less specific than either GDx method (p^≤0.004). Diagnostic accuracy of the GDx-VCC/ECC nerve fiber indicator (NFI) and RTVue-OCT average RNFLT were similar. Of the detected glaucoma cases, 87.7% were identified both by GDx-VCC/ECC NFI and average RNFLT of RTVue-OCT.

In this clinical setting, all methods were similarly highly specific, but for localized RNFLT damage RTVue-OCT was statistically and clinically significantly more sensitive than GDx-VCC and GDx-ECC. Most detected glaucoma cases were identified with all 3 methods.

To compare intraocular pressure (IOP) measured using a dynamic contour tonometer (DCT) and a Goldmann applanation tonometer (GAT) with in vivo intracameral IOP, and establish the relationship between DCT, GAT and central corneal thickness (CCT) in patients with primary open-angle glaucoma (POAG).

We examined 50 eyes of 50 patients with POAG scheduled for glaucoma or cataract surgery. Immediately before surgery, CCT, GAT and DCT IOP were assessed, after which manometry of the anterior chamber was performed. A Bland-Altman plot was used to test the agreement among the 3 measurements of IOP, and univariate and multivariate regression analyses were used to evaluate the effect of CCT on DCT and GAT.

On average, the DCT readings were 4.0±1.6 mmHg higher than the GAT readings and 2.3±2.4 mmHg higher than the manometric readings; the GAT measurements were generally a mean 1.7±1.8 mmHg lower than the manometric readings. The CCT had an almost similar influence on DCT and GAT measurements (p=0.84).

The DCT-measured IOP was significantly higher than that measured by means of GAT and anterior chamber manometry. The DCT and GAT readings were both influenced by CCT to the same extent.

The aim of the study was to investigate the optic nerve head parameters of healthy macrodiscs to provide standard measurements for them to be the basis for future quantitative comparisons.

Sixty-nine subjects with macrodisc (disc area larger than 2.82 mm²) and 91 healthy controls (disc area between 1.16 and 2.82 mm²) were recruited. After a complete ophthalmic examination, confocal scanning laser ophthalmoscopy was performed in all participants. The stereometric parameters of confocal scanning laser ophthalmoscopy examination and the proportion of subjects classified as normal, borderline, and glaucomatous by the Moorfield Regression Analysis were compared between groups.

A total of 160 subjects were included in the study. The average disc sizes in the control and macrodisc groups were 2.14±0.33 mm² and 3.36±0.36 mm², respectively. Cup area (p<0.001), rim area (p=0.01), cup volume (p<0.001), cup/disc area ratio (p<0.001), linear cup/disc ratio (p<0.001), mean cup depth (p<0.001), maximum cup depth (p<0.001), and cup shape measure (p<0.001) differed significantly between the 2 groups. The parameters of the optic nerve head which did not differ significantly between groups were rim volume (p=0.17) and height variation contour (p=0.88). A significantly higher number of eyes were erroneously identified as abnormal (15.1% vs 79.4%) by Moorfield Regression Analysis in the macrodisc group (p<0.001).

Rim volume and height variation contour were the only optic nerve head topographic parameters that were similar in eyes with large and normal disc sizes. They seem to be promising parameters in the evaluation and comparison of the optic nerve head of subjects with macrodisc.

To evaluate the efficacy and safety profile of a new crosslinked sodium hyaluronate drainage implant in nonpenetrating glaucoma surgery.

From July 2008 until January 2010, 55 eyes from 55 patients with glaucoma were operated upon. After a standard deep sclerectomy was performed, a crosslinked sodium hyaluronate (HEALAflow®) was injected under the superficial scleral flap and underneath the conjunctiva. The main outcomes measured were mean intraocular pressure (IOP), mean number of antiglaucoma medications, presence of postoperative complications, and clinical aspect of the filtering bleb.

For the 55 eyes, the mean follow-up was 12.0±5.1 months, the mean preoperative IOP was 21.6±7.2 mmHg, and the mean number of antiglaucoma medications before surgery was 2.4±1.2. At final follow-up visits, the mean IOP went down to 11.5±3.0 mmHg; the mean number of antiglaucoma medications was reduced to 0.5±0.9. The filtering bleb was visible on 49 eyes (89%). There were 5 hypotonies (IOP < 6 mmHg) and 3 iris incarcerations. Complete success rate (IOP ≤18 mmHg without antiglaucoma medication) was 70% and the overall success rate (IOP ≤18 mmHg with and without antiglaucoma medication) was 91%.

The slow resorbable highly crosslinked sodium hyaluronate drainage implant fills up the intrascleral and subconjunctival space, preventing postoperative scarring and fibrosis of the filtering site and helping to maintain a functional filtration after nonpenetrating glaucoma surgery. The IOP was significantly lowered with few numbers of postoperative complications and less medication.

To assess the retrobulbar hemodynamic parameters in the ophthalmic artery (OA), central retinal artery (CRA), and short posterior ciliary arteries (PCA) after decreasing elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) by using color Doppler imaging.

A total of 46 eyes from 46 patients with OAG, with elevated IOP, were consecutively included in this prospective study. Peak-systolic velocity, end-diastolic velocity, and Pourcelot resistivity index were assessed in the OA, CRA, and PCA. The IOP was measured with Goldmann applanation tonometer (GAT) and the dynamic contour tonometer (DCT), 3 times respectively. Ocular pulse amplitude (OPA) appeared during the DCT measurement.

After decreasing the elevated IOP, measured with both GAT and DCT, the retrobulbar parameters showed no differences as compared with baseline measurements. After Bonferroni correction (p≤0.0042, alpha/12), statistical significance appeared in retrobulbar hemodynamics only in DCT (29.3±6.4 vs 15.5±4.2 mmHg), GAT (33.0±8.3 vs 15.8±7.0 mmHg), and OPA measurements (4.1±1.3 vs 2.7±1.4 mmHg), in comparison to baseline. There was no correlation between the changes in IOP measured with either DCT or GAT and the changes in the retrobulbar hemodynamic parameters (p>0.05 for all).

The results of our study suggested a lack of correlation between the changes in IOP, measured with either DCT or GAT, and the changes in the retrobulbar hemodynamic parameters. The results of our study might suggest that the blood flow disturbances found in glaucoma patients are independent of the IOP.

Glaucoma drainage implants are a useful alternative in treating glaucomas that are resistant to medical therapy and conventional glaucoma filtration surgery. The aim of this study is to evaluate flexible Ahmed glaucoma valve implant for selected cases of refractory glaucoma regarding its efficiency in controlling intraocular pressure (IOP) and possible postoperative complications of its implantation and their management.

Patients included in this study were selected from patients with uncontrolled IOP by conventional filtration surgery as well as maximum tolerable topical medical treatment when surgery or laser is unlikely to control IOP. For every patient, complete history of age, sex, and history of previous ocular disease was done. Ocular examination for IOP measurement, best-corrected visual acuity measurement, and condition of conjunctiva was done. Ahmed glaucoma valve flexible plate implant (FP7 and FP8) was used.

The present study included 40 eyes of 40 patients and preoperative IOP ranged from 32 mmHg to 58 mmHg with a mean of 40.36 ± 7.78 mmHg. The postoperative IOP ranged between 14.0 mmHg and 28.0 mmHg with a mean of 18.73 ± 4.8 mmHg. The criteria of success were applied in 37 eyes of 40 eyes (92.5%); they included 30 eyes (81.8%) with absolute success and 7 eyes (18.9%) with partial success.

Flexible Ahmed glaucoma valve plate implant is a satisfactory method for controlling elevated IOP in cases of refractory glaucoma with success rate of 92.5% and lower incidence of immediate postoperative and implant-related complications.

To describe a case series of combined 23-gauge vitrectomy and pars plana Baerveldt tube insertion for intraocular pressure (IOP) control in eyes with glaucoma resistant to maximum tolerated medical therapy and/or having failed previous IOP-lowering procedures.

Eight consecutive patients (8 eyes) undergoing a combined procedure were identified and included in this study. Outcome measures included preoperative and final best-corrected visual acuity (VA), IOP, number of glaucoma medications, and complications. Changes in IOP and glaucoma medications were compared by a paired t test. A Kaplan-Meier survival curve was constructed to evaluate IOP control as a function of time.

Mean patient age was 70.9 years while the mean follow-up time was 12.1 months. Open angle glaucoma was diagnosed in 5 (68%) eyes. Six (75%) eyes were pseudophakic. All eyes received a 250-mm² pars plana Baerveldt tube. Vision remained the same or improved in 6 (75%) eyes. Mean preoperative IOP and number of glaucoma medications were significantly (p<0.05) reduced by the combined procedure. Visual acuity of 5 (63%) eyes improved or remained unchanged. Six (75%) eyes encountered minor complications not requiring a return to the operating room. One (13%) eye underwent drainage of hemorrhagic choroidals on postoperative day 12.

A combined 23-gauge vitrectomy and pars plana Baerveldt tube insertion could be considered a useful procedure in reducing IOP and the number of glaucoma medications in eyes with refractory glaucoma.

To develop a reliable and practical questionnaire for glaucoma awareness and evaluate the impact of potential determinants.

Patients with primary open-angle, pigmentary, and exfoliation glaucoma, as well as healthy controls, were recruited. The instrument included questions about demographic characteristics, as well as 8 questions assessing the participant's familiarity with glaucoma. Rasch analysis was used for the validation of the questionnaire. The effect of demographics as potential determinants of awareness was examined with a multivariate logistic regression analysis. Bonferroni-corrected statistical significance was tested with the Mann-Whitney U test or one-way analysis of variance. Association between demographics and questionnaire scores was examined with Spearman correlation.

As indicated by power analysis, responses from 175 patients (mean age 65.5 years) and 314 controls (mean age 43.3 years) were analyzed. Rasch analysis indicated no multidimensionality and good item-person targeting. Mean ± SD awareness scores for the glaucoma and control groups were 4.43±2.10 and 4.20±2.11, respectively (p=0.207). Sex and residence were not predictors of disease awareness, whereas educational level was only a determinant in the control group (p<0.001). Income was a predictor only for patients (r=0.357, p<0.001), whereas family history was predictive for both groups (p<0.001). Logistic regression analysis revealed that only family history was associated with increased awareness (χ²=4.61, p=0.03, odds ratio 1.98).

This study introduces a practical and valid instrument for the assessment of glaucoma awareness.

To evaluate the following in patients with aniridia: age at first examination at the University Eye Hospital and age at diagnosis of glaucoma; visual acuity; frequency of family history of aniridia; and frequency of ocular and general diseases associated with aniridia.

This was a consecutive examination of 30 unrelated patients with aniridia and retrospective evaluation of ophthalmologic, pediatric, and internal findings. The relative frequency of age at glaucoma diagnosis within decades was evaluated for the 20 patients with aniridia and glaucoma. Statistical analysis was performed using the Mann-Whitney test.

Relative frequency of the age of patients with aniridia at time of glaucoma diagnosis within the following decades was as follows: from birth to 9 years: 15%, 10-19: 15%, 20-29: 15%, 30-39: 15%, 40-49: 35%, and 50-59: 5%. Visual acuity in the better eye of 20/100 or less was found in 60%. Family history of aniridia was found in 33.3% of patients, with 1-4 relatives with aniridia. A total of 76.7% of patients had congenital cataract, and 66.7% had glaucoma. Mean maximum intraocular pressure of the 20 patients with glaucoma was 35.9 mmHg in the right and 32.6 mmHg in the left eye. A total of 53.3% had nystagmus, 26.6% corneal opacifications, 16.7% bilateral lens dislocation upwards, 6.7% optic nerve hypoplasia, 3.3% poor foveal development, and 3.3% Wilms tumor.

Up to the age of 40 years, 15% of patients were diagnosed with glaucoma per age decade. Frequent bilateral glaucoma and similar bilateral height of intraocular pressure suggest a genetic glaucoma disposition with malformation at Schlemm canal, besides possible sequential anatomic changes in the chamber angle. Associated ocular abnormalities limit visual prognosis.

To assess the relationship of ocular pulse amplitude (OPA), as measured by dynamic contour tonometry (DCT), with structural and functional damage in patients with open-angle glaucoma (OAG).

In this cross-sectional, observational study, 242 eyes of 139 patients with OAG underwent Goldmann applanation tonometry (GAT), DCT, central corneal thickness (CCT) measurement, visual fields examination (Octopus, Haag Streit), and complete ophthalmologic examination. Linear regression analysis was used to analyze the effect of OPA, DCT, GAT, and CCT to the mean defect (MD) of the visual fields and to the vertical cup to disc ratio (CDR).

Ocular pulse amplitude was the only variable that showed a significant association with MD (slope=–1.1, p=0.012), in contrast to GAT (p=0.98), DCT (p=0.32), and CCT (p=0.42). Ocular pulse amplitude was also negatively associated with CDR (slope=–0.028, p=0.0001). Additional multiple regression analysis revealed that OPA (R2=0.12, r=–0.25, slope=–0.02, p=0.033), GAT (r=–0.27, slope=–0.01, p=0.027), and CCT (r=–0.18, slope=–0.001, p=0.012) were statistically significantly correlated to CDR, while DCT was not (r=–0.20, slope=0.003, p=0.46). Ocular pulse amplitude did not differ statistically significantly (p=0.93) between eyes with (2.79±1.42) and without (2.77±1.21) prior trabeculectomy. No statistically significant difference of OPA was observed between diagnosis groups (p=0.255).

Decreased OPA seems to be correlated with increased glaucomatous functional and structural damage in OAG. Assessment of OPA by DCT could therefore serve as an important additional parameter in the evaluation of glaucoma patients.

To present a case with co-existence of Cogan-Reese syndrome and exfoliation syndrome.

A 72-year-old Caucasian woman presented for consultation due to uncontrolled intraocular pressure (IOP) of the right eye. Clinical examination revealed the presence of Cogan-Reese syndrome and exfoliation syndrome OD. This eye exhibited elevated IOP, open anterior chamber angle, advanced glaucomatous optic nerve head damage, and severe glaucomatous visual field loss. The left eye was completely normal without IOP elevation or visual field damage. To our knowledge this is the first case report demonstrating the coexistence of the Cogan-Reese syndrome, exfoliation syndrome, and secondary open-angle glaucoma. Since both syndromes frequently lead to secondary open-angle glaucoma, it is not feasible to determine with certainty which condition was the cause of secondary open-angle glaucoma in our case. It is conceivable that both conditions contributed to glaucoma development.

Cogan-Reese syndrome, exfoliation syndrome and secondary open-angle glaucoma may present on the same eye.