A 1-year study to compare the efficacy and safety of once-daily travoprost 0.004%/timolol 0.5% to once-daily latanoprost 0.005%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension.

PURPOSE: The objective of the study was to compare the intraocular pressure (IOP)-lowering efficacy and safety of travoprost 0.004%/timolol 0.5% ophthalmic solution (Trav/Tim) to latanoprost 0.005%/timolol 0.5% ophthalmic solution (Lat/Tim), dosed once daily in the morning, in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). METHODS: This was a randomized, double-masked, multicenter, parallel group, active-controlled study conducted at 41 sites. At the eligibility visit the patients were randomized (1:1) to the assigned masked medication if they met inclusion/exclusion criteria, and the mean IOP values in the eligible eyes were > or =24 mmHg at 9 AM and > or =21 mmHg at 11 AM and 4 PM. Patients were excluded if the mean IOP in either eye was >36 mmHg. Patients were instructed to administer the assigned medication each morning at 9 AM. During the treatment phase of the study, IOP was measured at 9 AM at week 2, week 6, month 3, and month 9. At the month 6 and month 12 visits, IOP was measured at 9 AM, 11 AM, and 4 PM. Statistical methods included a repeated measures analysis of variance (ANOVA); to test for noninferiority, a 95% confidence interval for the treatment group difference was constructed based on the ANOVA results for each time point at month 12. RESULTS: Patients (n=408) with OAG or OH were enrolled at 41 sites. One patient withdrew prior to receiving medication so 207 in the Trav/Tim group and 200 in the Lat/Tim group were evaluable for safety. Baseline demographic characteristics as well as IOP values showed no statistical differences between the two groups. Trav/Tim provided lower mean IOP values than Lat/Tim that were statistically significant at the week 2 9 AM (p=0.0081), month 6 9 AM (p=0.0056), and month 6 11 AM (p=0.0128) time points and at 9 AM time point pooled across all visits (p=0.0235) when mean IOP was 0.6 mmHg lower in the Trav/Tim group. Treatment-related adverse events were mild in both groups. Although hyperemia was reported from a higher percentage of patients in Trav/Tim group, differences in average hyperemia scores between the two groups were not considered clinically relevant. CONCLUSIONS: Travoprost 0.004%/timolol 0.5% ophthalmic solution produced mean IOP levels that are statistically noninferior to latanoprost 0.005%/timolol 0.5% ophthalmic solution. Furthermore, at 9:00 AM, 24 hours after dosing, IOP was statistically lower for travoprost 0.004%/timolol 0.5% pooled across all visits. Travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution is an effective treatment for reducing IOP and it is safe and well-tolerated in patients with OAG or OH.

Early treatment with cyclosporin in serpiginous choroidopathy maintains remission and good visual outcome.

AIMS: To describe management and clinical outcomes of serpiginous choroidopathy treated primarily with cyclosporin at a tertiary uveitis referral centre METHODS: A case series of 14 eyes of seven patients with serpiginous choroidopathy with follow up ranging from 1.3 to 13 years is described. All patients had fundus lesions consistent with serpiginous choroidopathy, were investigated for systemic disease, had fluorescein angiography, and were treated with combined immunosuppressive therapy including cyclosporin. RESULTS: No patients suffered significant loss of acuity after starting systemic immunosuppression with cyclosporin as the primary agent. All but one patient achieved remission and were able to stop medications with no recurrences in the follow up period. Side effects from cyclosporin were well tolerated and there were no serious complications from immunosuppression. CONCLUSIONS: Cyclosporin is a safe and effective option with which to manage serpiginous choroidopathy. Significantly, adequate immunosuppression can result in clinical remission and cessation of therapy in some patients.

A pilot study of a system for grading of drainage blebs after glaucoma surgery.

PURPOSE: To develop and evaluate a novel bleb grading scheme for clinical and photographic evaluation. METHOD: A system for grading bleb photographs using widely applicable parameters was designed, and reference color photographs printed. A prospective masked agreement study was undertaken comparing slit lamp examination with mono and stereo photographs; 36 eyes of 28 patients with previous glaucoma surgery were graded according to defined parameters on a 1 to 10 scale clinically at the slit lamp by four ophthalmologists and two optometrists. Standardized stereo and mono photographs of the blebs were taken on the same day. The photographs were graded at least one week later in a masked fashion by the same observers, with grading of mono and stereo photographs also separated by one week. Analysis was performed to determine the variability and agreement between slit lamp results and photographic results, and to identify the presence of systematic bias. RESULTS: High levels of agreement were found between slit lamp and both stereo and mono photographs for vascularity indices, bleb wall thickness, and bleb elevation. Lower levels of agreement were found for the relative components of demarcated versus diffuse areas of the bleb, and for the total width of the bleb. The interquartile range for the median difference between slit lamp and photograph grading was -1.0 to 1.0 for all criteria except diffuse component (-2.0 to 2.0), and the median difference for all scores was 0.0. The median interobserver difference for all criteria was 0.0; the quartile range for all scores was between -0.5 and 1.0 except for diffuse component and width assessments whose quartiles fell in the -1.75 to 1.0 range. Examiners agreed with photographic grading within +/- 1 in more than 80% of gradings for vascularity and bleb height, within +/- 1 in more than 75% of gradings for bleb wall thickness, within +/- 2 in 61% of bleb width assessments, and +/- 2 in 59% of diffuse component. CONCLUSION: This bleb grading system is reproducible clinically and photographically. High levels of agreement between scores for photographs versus slit lamp examination were found for most categories, with good interobserver agreement for both photograph and slit lamp grading. Further refinement of scoring and reference photographs is required for optimization, especially for grading of bleb morphology.

Medium-term outcomes of safe surgery system trabeculectomies.

AIM: To assess the safety and success of Safe Surgery System trabeculectomy beyond 3 years. METHODS: Consecutive case series of 39 eyes in 32 patients. Trabeculectomy was performed using fornix-based conjunctival flap, standard trabeculectomy punch, adjustable scleral flap sutures and antimetabolite treatment. Primary outcome of surgical failure was defined by two criteria: (A) need for further surgery, glaucoma medications or an intraocular pressure (IOP) >21 mm Hg during >10% of follow-up; or (B) IOP >15 mm Hg for >10% follow-up. A relatively aggressive regime of bleb needling and subconjunctival injections was used postoperatively in an attempt to reduce bleb fibrosis and failure. The mean follow-up was 42 months (range 25-55). RESULTS: The rate of surgical failure was 4.4% per eye-year for criterion A, and 8.0% per eye-year for criterion B. Complications were few and compared favourably with other published series. CONCLUSION: The Safe Surgery System for trabeculectomy provides excellent IOP control both during the operation and in the short and medium term postoperatively, with few complications or surgical failures.

Do scleral flap dimensions influence reliability of intraocular pressure control in experimental trabeculectomy?

AIM: To compare the effect on intraocular pressure (IOP) of large vs small scleral flap size during trabeculectomy using adjustable sutures. METHODS: Trabeculectomy operations were performed on nine donor human eyes connected to a constant flow infusion with real-time IOP monitoring. Large scleral flaps (4 x 4 mm, 16 mm(2), n=12) or small scleral flaps (3 x 2 mm, 6 mm(2), n=9) were constructed over 0.76 mm(2) sclerostomies. For each procedure, equilibrium IOP was measured following tight closure with two four-throw adjustable 10-0 nylon sutures. RESULTS: Five scleral flaps were thin or poorly constructed; four of these were in the initial seven procedures, implying learning effect. These had a mean absolute IOP of 7.6 mmHg (range 2.7-12.4 mmHg) and mean relative IOP of 28.3% of baseline (range 10-45.8%) after closure. In the remaining 16 good quality procedures, mean IOP was 1.3 mmHg (range 0-3.4 mmHg) after sclerostomy, confirming minimal outflow resistance before closure. Following flap closure mean IOP was 20 mmHg (SD 4.4, range 15.5-29.3 mmHg) for large (n=8), and 18.7 mmHg (SD 3.6, 15.9-25.8 mmHg) for small (n=8) flaps (unpaired t-test, P=0.26). Mean IOP (% baseline) was 71.6% (SD 8.4, range 60.6-86.6%) and 66% (SD=12.7, 46.8-86.6%) for large and small flap groups, respectively (unpaired t-test, P=0.2). CONCLUSIONS: Well-constructed scleral flaps of both sizes were able to support an average IOP at least two-thirds of baseline, and both had similar absolute IOP levels. Errors in flap construction resulted in loss of IOP control. Smaller flap size does not appear to compromise control of early postoperative IOP using adjustable sutures.

In vivo fibreoptic confocal imaging (FOCI) of the human ocular surface.

Recent developments in the miniaturization of confocal imaging technology have resulted in the development of a hand-held confocal microscope probe. There are many structures of interest in the human eye that are within reach of a fluorescence-mode confocal microscope; this study assessed the feasibility of in vivo human ocular imaging. Safety analysis was undertaken to ensure that the laser light applied to the ocular surface structures constituted no threat to patient safety. A fibreoptic confocal imaging (FOCI) probe using an illumination wavelength of 488 nm was applied to the ocular surface of four volunteers after topical administration of sodium fluorescein. Stabilization of the probe on the ocular surface was difficult, but movement artefacts could be minimized to a satisfactory level in most subjects by a variety of procedures. High-quality images of conjunctival epithelial and goblet cells, lamina propria structures, accessory lacrimal glands, lacrimal ducts and superficial sclera were obtained. Lateral resolution was 1-1.5 microm and axial resolution was approximately 30 microm; individual erythrocytes could be seen in conjunctival vessels. The rete ridges and intervening epithelial components, including the probable location of corneal limbal stem cells, could be viewed, although it was not possible to distinguish cell subgroups. The study showed that fluorescence-mode imaging of the ocular surface is a viable and promising tool for assessment of diseases and processes involving superficial ocular structures. Refinement of equipment and techniques, particularly probe stabilization, is necessary to realize fully the potential of FOCI for ocular use.

Spontaneous inferior subconjunctival haemorrhages in association with circumferential drainage blebs.

AIM: To describe an association of spontaneous inferior subconjunctival haemorrhages in eyes with circumferential drainage blebs following trabeculectomy. METHODS: Observational case series. Patients with multiple episodes of spontaneous inferior subconjunctival haemorrhage following trabeculectomy (with or without antimetabolite) and circumferential blebs are presented. All patients described had multiple episodes. A possible mechanism is discussed. RESULTS: The number of spontaneous haemorrhages ranged from two to more than 10. All individual haemorrhages resolved spontaneously without adverse sequelae CONCLUSIONS: A new clinical presentation of inferior subconjunctival haemorrhage in association with circumferential blebs is described.

Diplopia from peribulbar ropivicaine.

PURPOSE: To report a previously undescribed side-effect of ropivicaine (Naropin) used in peribulbar anaesthesia. METHODS: We report nine cases identified prospectively with symptomatic diplopia, predominantly vertical, following Ropivicaine use for peribulbar anaesthesia in routine cataract surgery. These nine cases occurred in a 10-week period from a total of 77 patients given 7 mL peribulbar ropivicaine (10 mg/mL) with 750 units hyalase prior to cataract extraction by a single surgical team. RESULTS: None of the cases had preoperative ocular motility disturbances and none had superior rectus traction sutures. All diplopia resolved in less than 30 h. CONCLUSIONS: Ropivicaine may have a prolonged motor block resulting in diplopia of up to 30 h duration after peribulbar anaesthesia.

Exercise-induced visual loss associated with advanced glaucoma in young adults.

PURPOSE: To highlight the phenomenon of exercise-induced visual loss associated with advanced glaucoma and to discuss the possible underlying mechanisms. METHODS: Three young adult patients with congenital or juvenile-onset glaucoma presenting with visual loss which occurred during exercise underwent ophthalmic examination. In 2 cases, visual function parameters, including visual fields (Humphrey full threshold perimetry) were measured before and after exercise. RESULTS: All patients clearly described visual loss during exercise. In the 2 cases in which data were available, significant impairment in central visual acuity and reduced foveal sensitivity and mean deviation on visual field analysis occurred during exercise of mild to moderate intensity with complete or near complete recovery of visual function upon cessation of exercise. CONCLUSION: Young patients with advanced glaucomatous optic neuropathy should be questioned regarding exercise-induced visual disturbance. We hypothesise that a 'vascular steal' is the likely mechanism underlying this phenomenon. Patients should be advised to limit activities which induce their symptoms, and therapeutic measures to promote ocular blood flow should be considered.