Pfizer, UK National Institute for Health Research Biomedical Research Centre.

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Aims: To prospectively study the evolution of possible high risk features of conjunctival filtration blebs like avascularity, transconjunctival oozing (TCO), and leaks after mitomycin C (MMC) enhanced glaucoma surgery. Methods: Single observer, 2 year prospective study on bleb characteristics of 125 eyes of 125 consecutive patients who had MMC augmented glaucoma surgery with initially successful filtration. MMC (0.2 mg/ml for 2 minutes in most cases) was applied on the area of the scleral flap before dissection. Glaucoma surgeries included were trabeculectomy, deep sclerectomy, and combined procedures. A dry fluorescein strip was applied on the avascular part of the bleb and observed for aqueous egress with flow (point leak, PL) or without (TCO). Results: The mean time (95% CI) for observing bleb avascularity, TCO, and bleb leaks were 106 days (69 to 143), 208 days (155 to 261), and 609 days (559 to 659), respectively. Bleb leaks were observed in 17 eyes (13.6%)-15 (24.6%) in the trabeculectomy group and two (3.1%) in the deep sclerectomy group (p = 0.003). Kaplan-Meier survival analyses showed that the probability of observing bleb avascularity at sixth, 12th, and 24th month after surgery was 56%, 71%, and 73%, respectively. In eyes with avascular blebs, the probability of developing TCO and leaks was 77% and 1% at 6 months, 81% and 12% at 12 months, and 95% and 26% at 24 months, respectively. Cox's regression analyses and log rank tests showed that eyes with larger avascular blebs (.4 mm) were more likely to develop TCO (hazard ratio 3.77, p = 0.001) and delayed bleb leaks were more likely to be seen in eyes of the trabeculectomy group rather than the deep sclerectomy group (hazard ratio 0.06, p = 0.0006). Conclusions: MMC application over the area of scleral flap dissection during glaucoma surgery is associated with a high incidence of bleb avascularity, TCO, and delayed bleb leaks. Most eyes developed bleb avascularity within the first year after surgery. TCO will eventually be seen in all eyes with avascular blebs and the incidence of leaks gradually increases with time. This study shows that patients with eyes undergoing glaucoma surgery with MMC and avascular blebs should be monitored indefinitely.

Aims To investigate the comparative efficacy and safety of deep sclerectomy with and without intraoperative mitomycin C (MMC) application for lowering the intraocular pressure (IOP). Methods A total of 71 eyes of 71 consecutive patients who had routine deep sclerectomy (DS), nonaugmented (DS-noMMC) or with mitomycin C (DS-MMC) augmentation (0.2 mg/ml for 2 min) and follow-up of 4 months or more were identified from an ongoing prospective database on glaucoma surgery. Indications for MMC use were the presence of risk factors for subconjunctival scarring and low target IOPs. MMC 0.2 mg/ml was applied in the sub-Tenons space for 2 min. Results There were 19 eyes in the DSnoMMC group and 52 eyes in the DS-MMC group. In 11 eyes (15.5%), the procedure was complicated by intraoperative perforation of the trabeculo-Descemet's window. Eyes in the DS-MMC group had significantly lower IOPs (MANOVA, P ¼ 0.04). Kaplan-Meier survival curve analysis showed that the probability of maintaining IOP below target IOP level, below 18 mmHg and below 14 mmHg at 1 year was 51, 67, and 35% for the DS-noMMC group and 80, 86, and 74% for the DS-MMC group. The survival rates of the DS-MMC group were not statistically significant (P ¼ 0.06) when the success criterion was maintaining an IOP less than 18 mmHg but were significant for the other criteria, namely IOP less than target levels (P ¼ 0.03) and less than 14 mmHg (P ¼ 0.03). Nd:YAG goniopuncture to lower IOP to target levels was done more frequently in the DS-noMMC group (13 eyes, 81%) than the DS-MMC group (20 eyes, 45%) and this difference was significant (P ¼ 0.03). The prevalence of avascular areas within filtration blebs and transconjunctival oozing of aqueous was significantly higher in the DS-MMC group (Po0.01).Conclusions The use of intraoperative MMC during deep sclerectomy has a significant effect on the postoperative IOP and increases the probability of achieving target IOPs. However, our current technique of MMC application is associated with a higher incidence of avascular blebs and transconjunctival oozing.

This study suggests that MMC is more effective than 5-FU for needle revision of failed trabeculectomy blebs.

ABSTRACT.Purpose: This study aimed to investigate the safety and efficacy of Nd:YAG laser goniopuncture (LGP) in lowering intraocular pressure (IOP) after deep sclerectomy (DS). Methods: We reviewed the outcomes in 258 eyes of 258 consecutive patients who underwent DS or combined phacoemulsification and DS between August 2001 and December 2003. Mitomycin C was used during surgery in 192 eyes (74.4%). Results: Mean follow-up was 40 ± 11 months after DS and 31 ± 12 months after LGP. Laser goniopuncture was performed in 173 eyes (67.0%). The mean interval between LGP and DS was 10.3 ± 8.7 months. The probability of LGP being performed was 63.1% (95% confidence interval [CI] 57.3-69.4) at 36 months after surgery. At 2 years after LGP, the probability of maintaining IOP < 15 mmHg with a 20% decrease from the pre-laser IOP and no further glaucoma procedure or medication was 49.7% (95% CI 41.9-57.1). Iris covering the trabeculo-Descemet's membrane was the only factor significantly associated with the failure of LGP (hazard ratio 3.0, p < 0.001). Complications observed after LGP included peripheral anterior synechiae in 23 (13.2%), hypotony in seven (4.0%), late acute IOP rise in three (1.7%), delayed bleb leak in one and blebitis in two eyes. Argon laser iridoplasty was performed in 45 (26.0%) and needle revision in 41 (23.7%) eyes. Conclusions: ND:YAG laser goniopuncture is an effective procedure to further lower IOP after DS. An IOP of < 15 mmHg is achieved and maintained for ‡ 2 years in about 50% of cases after a single LGP procedure. There are potentially serious complications associated with the procedure. Regular gonioscopy is recommended following LGP to detect any occlusion of the goniopuncture by the iris.

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BackgroundVisual field (VF) tests are the benchmark for detecting and monitoring the eye disease glaucoma. Measurements from VF tests are variable, which means that frequent monitoring, perhaps over a long period of time, is required to accurately detect true glaucomatous progression. In 2009, guidelines for the diagnosis and management of glaucoma issued by the National Institute for Health and Care Excellence revealed an absence of research evidence about the clinical effectiveness and cost-effectiveness of using different monitoring intervals to detect disease progression. However, the European Glaucoma Society (EGS) guidelines on patient examination recommend that newly diagnosed glaucoma patients should undergo VF testing three times per year in the first 2 years after initial diagnosis.ObjectivesThe primary objective of this project was to explore the clinical effectiveness and cost-effectiveness of using different monitoring intervals to detect VF progression in newly diagnosed glaucoma patients. Other objectives sought to (1) explore glaucoma patients’ views and experiences of monitoring using focus groups; and (2) establish glaucoma subspecialists’ attitudes regarding frequency of VF testing using a five-item questionnaire.DesignThese questions were investigated using a multicentre audit of current practice and existing NHS data (VF records from almost 90,000 patients). New research knowledge was provided through statistical and health economic modelling of these and additional published data.ResultsThe multicentre audit showed that VF monitoring is, on average, carried out annually. Patient focus groups indicated that, although patients do not like VF testing, they accept it as a critical part of their care. Patients raised concerns regarding distracting testing environments, quality of instructions, explanation of results and excessive waiting times. Questionnaires revealed that clinicians’ attitudes towards the frequency of VF testing varied considerably, and many glaucoma specialists believed that current recommendations are impractical. Statistical modelling suggested that EGS recommendations could be clinically effective as progression can be identified sooner than is possible with annual testing. Health economic modelling suggested that increased VF monitoring may also be cost-effective [incremental cost-effectiveness ratio (ICER) was equal to £21,679].ConclusionsStatistical modelling of VF data suggests there is strong rationale for following EGS recommendations with the primary benefit of providing better information about fast-progressing patients. Our health economic model suggested that increasing VF testingmaybe cost-effective (ICER was equal to £21,679), especially when accounting for gains to society. Nevertheless, many clinicians consider increased VF testing of patients impossible with current resources. In addition, patient focus groups raised concerns about the practicalities of delivery of VF tests.Future workResults from this study could inform the design of a prospective randomised comparative trial of different VF monitoring intervals in glaucoma linked to stratifying patients according to risk factors for progression. The statistical model for VF data can be further developed to be used as a practical tool for optimising individualised follow-up. The views of clinicians and patients indicate that service delivery of VF testing is an important issue and worthy of further investigation. Ensuring the confidence and co-operation of the patient should be at the centre of future research into the most efficient strategies for glaucoma monitoring.FundingThis work was funded by the National Institute for Health Research Health Services and Delivery Research programme.