Real world outcomes of ocriplasmin use by members of the British and Eire Association of Vitreoretinal Surgeons.

PurposeTo describe a survey of the use of ocriplasmin by members of the British and Eire Association of VitreoRetinal Surgeons (BEAVRS) for VitreoMacular Traction (VMT) and Full Thickness Macular Hole (FTMH) and compare it to published MIVI TRUST trial data.MethodsAll 173 BEAVRS members were contacted by email in October 2014 requesting data on all cases treated with ocriplasmin up to that date. The total number of cases, FTMH closure rate, VMT release rate and the frequency of adverse events were recorded. Results were compared with trial data.Results48 members responded reporting results from 241 eyes. The respective BEAVRS and MIVI TRUST trial closure rates for small FTMHs were 42.1 and 58.3% (P=0.09) and for medium FTMH 12.7 and 36.7% (P=0.01). The respective VMT release rates were 34.1 and 37.4% (P=NS). Retinal detachment was observed in 3.3% of the BEAVRS cohort compared with 0.4% in MIVI TRUST. Reduction in visual acuity to <6/60 was observed in 5.8% of the BEAVRS cohort and 0.6% in MIVI TRUST. Other complications not reported in the MIVI TRUST trial included an increase in FTMH basal diameter following unsuccessful ocriplasmin use in 46.9% of BEAVRS cases and zonular instability at the time of subsequent phacoemulsification in 2.4%.ConclusionMacular hole closure rates were lower in the BEAVRS survey than published in the MIVI TRUST trial data. The incidence of adverse events was greater than previously reported. The reasons for these disparities are unknown but could include positive reporting bias inherent to retrospective surveys, treatment and population differences.

The design and validation of an optical coherence tomography-based classification system for focal vitreomacular traction.

PURPOSE: To develop and validate a classification system for focal vitreomacular traction (VMT) with and without macular hole based on spectral domain optical coherence tomography (SD-OCT), intended to aid in decision-making and prognostication. METHODS: A panel of retinal specialists convened to develop this system. A literature review followed by discussion on a wide range of cases formed the basis for the proposed classification. Key features on OCT were identified and analysed for their utility in clinical practice. A final classification was devised based on two sequential, independent validation exercises to improve interobserver variability. RESULTS: This classification tool pertains to idiopathic focal VMT assessed by a horizontal line scan using SD-OCT. The system uses width (W), interface features (I), foveal shape (S), retinal pigment epithelial changes (P), elevation of vitreous attachment (E), and inner and outer retinal changes (R) to give the acronym WISPERR. Each category is scored hierarchically. Results from the second independent validation exercise indicated a high level of agreement between graders: intraclass correlation ranged from 0.84 to 0.99 for continuous variables and Fleiss' kappa values ranged from 0.76 to 0.95 for categorical variables. CONCLUSIONS: We present an OCT-based classification system for focal VMT that allows anatomical detail to be scrutinised and scored qualitatively and quantitatively using a simple, pragmatic algorithm, which may be of value in clinical practice as well as in future research studies.

Performance of a computerised visual acuity measurement device in subjects with age-related macular degeneration: comparison with gold standard ETDRS chart measurements.

PURPOSE: The aim of the study was to compare the performance of two different COMPlog computerised, single letter scoring, visual acuity (VA) measurements against gold standard Early Treatment Diabetic Retinopathy Study (ETDRS) chart measurements in patients with age-related macular degeneration (AMD). One computerised algorithm presented five and the other presented three letters per line; both computerised algorithms utilised half, rather than the full-letter width spacing standard on ETDRS charts that might induce crowding, fixation problems, increased test-retest variability (TRV), and bias. METHODS: Fifty patients with AMD (mean age 83 years) underwent timed test and retest VA measurements using ETDRS charts and COMPlog five (C5) and three (C3) letters per line computerised VA measurement algorithms. All tests utilised single-letter scoring methodology. Bland and Altman methods were employed. Performance was measured in terms of bias, TRV, and test time. RESULTS: The C5 and C3 scores showed no bias compared with the ETDRS chart measurements. C5 measurements had equal TRV to the ETDRS chart (±0.13 logMAR) with similar median test times (105 and 96 s, respectively). C3 measurements were slightly more variable (TRV ±0.17 logMAR), but 30 s quicker than ETDRS chart measurements. CONCLUSIONS: The closer letter spacing employed in COMPlog testing algorithms appears to have no adverse effect on VA measurements compared with the gold standard ETDRS chart in patients with AMD. The three letter per line testing algorithm facilitates faster testing but with a two letter increase in TRV.

Validation of printed and computerised crowded Kay picture logMAR tests against gold standard ETDRS acuity test chart measurements in adult and amblyopic paediatric subjects.

AIMS: The impression exists that picture acuity scores may overestimate function when subjects are switched to letter charts. This has not been systematically investigated. The aims of this study were to validate both printed crowded Kay picture (pCKP) and computerised CKP (cCKP) logMAR test acuity measurements against gold standard ETDRS letter chart scores. METHODS: A total of 30 adult subjects with various ophthalmic disease and 40 amblyopic children underwent test and re-test visual acuity measurements using the ETDRS chart, the pCKP logMAR test, and the cCKP acuity scores taken, using the COMPlog visual acuity measurement system. Bland and Altman methods were employed. RESULTS: Computerised and printed Kay picture acuity scores agreed well. Both Kay picture test measurements were systematically biased when compared with ETDRS chart measurements. No significant proportional bias was found. The test retest variability (TRV) of all three tests was found to be similar between ± 0.14 and 0.16 logMAR in both groups. CONCLUSIONS: All three tests were similarly replicable and computerised Kay pictures appear to be a valid alternative to hard copy Kay pictures. Kay picture acuity measurements were systematically biased when compared with the gold standard ETDRS. Measurement error means that differences of up to 0.16 logMAR may be observed in clinically stable patients when re-measured using the same technique. A combination of TRV and systematic bias can however lead to differences of up to 0.40 logMAR in stable amblyopic patients when switched from CKPs to ETDRS chart acuity measurements.

Predicting visual success in macular hole surgery.

AIM: Data on the outcome of surgery facilitate informed preoperative patient counselling. Most studies on the outcome of surgery for idiopathic full thickness macular hole surgery have concentrated on rates of anatomical closure. The aim of this study was to identify factors predicting visual success (better than 20/40; 6/12 Snellen) following macular hole surgery. METHODS: A retrospective study of 133 patients undergoing standardised macular hole surgery with at least 3 months of postoperative follow-up. All patients underwent preoperative measurement of the maximum macular hole diameter using optical coherence tomography. RESULTS: Multivariable regression analysis identified that age, preoperative visual acuity and macular hole size were significant predictors of visual success. The resulting model correctly classified the visual outcome of 80% of cases. Predicted rates of visual success varied from 93% in patients <60 years old with visual acuity better than 6/24 and a hole diameter of <350 mum, to 2% in patients those >79 years old with visual acuity of 6/60 or worse and hole diameter of >500 microm. CONCLUSION: The results provide a simple and clinically useful model to employ when counselling patients on macular hole surgery.

Vitreoretinal management of the complications of sickle cell retinopathy by observation or pars plana vitrectomy.

PURPOSE: To describe the management of vitreoretinal complications of sickle cell retinopathy. DESIGN: A retrospective interventional case series. METHODS: Review of an electronic patient record and clinical notes of 27 patients with vitreoretinal complications of sickle retinopathy. RESULTS: Six male patients and 21 female patients presented with a mean age of 41 years (range 28-67), 12 left eyes and 16 right eyes. The mean follow-up was 15.5 months (range: 3-60). Two patients were SS, and the remainders were doubly heterozygous (SC). In all, 10 were observed without surgery- three with vitreous haemorrhage, four tractional retinal detachments (TRD), and three rhegmatogenous retinal detachments (RRD). Two patients demonstrated spontaneous flattening of the retina- one RRD and one TRD. Eighteen eyes had pars plana vitrectomies (PPVs)- seven with vitreous haemorrhage, three RRD, three TRD, three ERM (one bilateral), and two macular holes. In all, 15 patients (83%) had improved vision postoperatively. The mean logMar preoperative visual acuity was 1.07 (Snellen equivalent 6/70), SD 0.62 was significantly improved postoperatively (mean 0.42 (6/15), SD 0.48, P=0.001). CONCLUSIONS: Sickle retinopathy occasionally presents with vitreoretinal complications. These can often be observed and may spontaneously regress. If surgery is required eyes respond to vitrectomy procedures with segmentation of sea fan proliferation.

Severe folding of the inferior retina after relaxing retinectomy for proliferative vitreoretinopathy.

PURPOSE: Proliferative vitreoretinopathy (PVR) is a severe complication of retinal detachment, which can be treated surgically by relaxing retinectomy. In this study, we describe patients with severe inferior retinal folding after this surgical intervention (SIRF). METHODS: A retrospective review of the electronic patient records of 254 patients who received relaxing retinectomies was performed to identify patients with SIRF. RESULTS: Five patients (1.97% of those with retinectomy) were identified with SIRF, mean age, 51.4 years; mean follow-up, 36 months. Three patients had rhegmatogenous retinal detachment (RRD) with PVR, one had a dropped nucleus with RRD and PVR and one with giant retinal dialysis from ocular trauma. SIRF was noted from a mean 4.2 months after the retinectomy. All involved the macula and visions were hand movements or perception of light. CONCLUSIONS: SIRF is an uncommon but devastating complication of relaxing retinectomy with a poor visual outcome. This is the first description of this condition that we are aware of.

A new technique of combined retinal and choroidal biopsy.

AIMS: To evaluate a new technique in large retinal and choroidal biopsies in patients with uveitis of unknown aetiology and chorioretinal lesions or infiltrate. METHODS: Retrospective, non-comparative, consecutive interventional case series. Patients were identified from the computerised patient database and from histopathology records. RESULTS: A total of nine patients were included in the study. The commonest indication of biopsy was panuveitis of unknown aetiology. Positive histological diagnoses from the chorioretinal biopsies were made in five cases (55.6%). Complications included vitreous haemorrhages and one case of retinal detachment. CONCLUSION: The technique of large chorioretinal biopsy described appears to be safe. It produced good amounts of chorioretinal tissue for histopathological analysis. Positive histology results were seen in the majority of the sample and especially in those where vitreous biopsy alone proved to be inadequate.

Vitrectomy for diabetic macular oedema.

AIM: To briefly review and discuss the literature on vitrectomy for diabetic macular oedema. METHODS: Literature review. RESULTS: There is a copious literature on the subject of vitrectomy for diabetic macular oedema (DMO). The most commonly hypothesised mechanism for the potential benefit of vitrectomy is relief of vitreomacular traction; however, both transvitreal oxygenation and improved growth factor diffusion away from the premacular retina have also been suggested to be potentially beneficial effects. Other systemic and local factors including duration of oedema, extent of ischaemia and exudation, and extent of laser may result in permanent photoreceptor and capillary damage, which precludes anatomical or visual benefit. Much of the literature on the subject of vitrectomy for DMO is retrospective and uncontrolled but strongly suggestive of a benefit in terms of improved acuity and reduced macular thickness following vitrectomy. There are five published small randomised controlled trials on this subject. Taken as a whole, these studies do not suggest a benefit from surgery. Selection of patients for surgery on the basis of OCT partial vitreomacular separation or clinical signs of traction such as an epiretinal membrane or taut thickened hyaloid has been reported to be associated with a modest improvement in prospective studies but this has not been subjected to controlled study. CONCLUSION: The evidence at present suggests that vitrectomy for DMO should be restricted to those with clinical or OCT signs of traction.

Validation of a computerised logMAR visual acuity measurement system (COMPlog): comparison with ETDRS and the electronic ETDRS testing algorithm in adults and amblyopic children.

BACKGROUND/AIM: The COMPlog clinical visual acuity measuring system is being developed for both routine and research use. This study aimed to validate its performance in amblyopic children and both normal and diseased adults against the gold standard ETDRS chart and the E-ETDRS computerised acuity measurement algorithm. METHOD: Timed test and retest fully interpolated five letters per line logMAR visual acuity measurements were taken for 70 adults and 59 amblyopic children using the ETDRS chart and the COMPlog visual acuity measurement system. 39 of the adults also underwent computerised acuity testing using the E-ETDRS testing algorithm. The tested adults included normals as well as subjects with a range of ocular diseases. The methods of Bland and Altman were employed with test-retest variability (TRV) expressed as 95% confidence limits for agreement. RESULTS: No significant bias was observed between the gold standard ETDRS acuity measurements and those taken with either COMPlog or E-ETDRS. TRVs of +/-0.12 logMAR and +/-0.10 logMAR were respectively found for COMPlog measurements in the amblyopic children and adult groups compared with +/-0.12 logMAR for the ETDRS chart in both groups. The TRV of the E-ETDRS system was slightly greater at +/-0.16 logMAR. Median testing times for COMPlog and ETDRS were 95 and 85 s and 66 and 56 s respectively in the paediatric and adult groups and 120 s for the E-ETDRS measurements on adults. DISCUSSION: COMPlog measurements agree well with and are similarly reliable to the gold standard ETDRS chart with comparable test times. E-ETDRS algorithm measurements took approximately twice as long.

How effective is macula-off retinal detachment surgery. Might good outcome be predicted?

PURPOSE: To determine factors associated with anatomical and functional outcomes of macula-off retinal detachment surgery in a modern vitreoretinal unit. METHODS: A retrospective casenote review of 185 patients presenting with macula-off retinal detachment was performed. Demographic and ocular characteristics were determined. Logistic regression analysis was used to determine (1) the effect of these factors on visual outcome and (2) their effect on primary and final anatomical success. RESULTS: Primary and ultimate anatomical success were achieved in 76 and 84% of cases. Patients with oil in at final follow-up were considered to be anatomical failures. Statistically significant factors predicting primary anatomical success using a multiple variable model were preoperative logMAR visual acuity, preoperative PVR and number of breaks. Preop logMAR visual acuity and duration of macular detachment were the statistically significant factors predicting ultimate success. In all, 44% of patients regained 6/12 Snellen or better with a median improvement of 0.78 logMAR. For prediction of visual outcome (in patients with no ocular comorbidity) only preoperative logMAR visual acuity achieved statistical significance (P=0.001) at the P=0.05 level. CONCLUSION: In all, 76% of macula-off detachments may be repaired with one operation and 44% of patients regain at least 6/12 Snellen. The median logMAR acuity increment of 0.78 far exceeds that seen in cataract surgery. Preoperative visual acuity is the most important factor predicting primary and final anatomical success as well as visual outcome. Preoperative PVR, number of breaks and duration of detachment also affect outcomes.

Factors predicting outcome of vitrectomy for diabetic macular oedema: results of a prospective study.

AIM: To determine preoperative demographic, clinical, and optical coherence tomography (OCT) factors which might predict the visual and anatomical outcome at 1 year in patients undergoing vitrectomy and inner limiting membrane peel for diabetic macular oedema (DMO). METHODS: A prospective, interventional case series of 33 patients who completed 1 year follow up. Measurements were taken preoperatively and at 1 year. Outcome measures were logMAR visual acuity (VA) and OCT macular thickness. A priori explanatory variables included baseline presence of clinical and/or OCT signs suggesting macular traction, grade of diabetic maculopathy, posterior vitreous detachment, fluorescein leakage and ischaemia on angiography, presence of subretinal fluid, and peroperative indocyanine green (ICG) use. RESULTS: 33 patients completed 1 year follow up. On average VA deteriorated by 0.035 logMAR (p = 0.40). Macular thickness significantly improved by a mean of 139 microm (95% CI; 211 to 67, p<0.001). Patients with evidence of clinical and/or OCT macular traction significantly improved logMAR acuity (logMAR improvement = 0.08) compared with patients without traction (logMAR deterioration 0.11, p = 0.01). Presence of subretinal fluid significantly predicted worse postoperative result (p = 0.01) CONCLUSION: On average, patients showed a statistically significant improvement in central macular thickness following treatment but a marginal acuity worsening. Presence of subretinal fluid on OCT is hypothesised to be exudative rather than tractional in nature. The visual benefit of vitrectomy for DMO in this study was limited to patients who exhibit signs of macular traction either clinically and/or on OCT.

Outcomes of macular hole surgery: implications for surgical management and clinical governance.

PURPOSE: The optimal method and timing of the surgical treatment for idiopathic macular holes remains unknown. The aim of this retrospective study was to identify factors associated with anatomical and visual success in macular hole surgery. METHODS: Case records of 55 patients undergoing macular hole surgery at three units in the 2-year period up to July 2002 were reviewed to identify factors associated with anatomical and visual success. The following potential prognosticators were evaluated: patient age, hole stage, hole latency prior to surgery, preoperative acuity, simultaneous phacoemulsification, and intraocular lens implantation, internal limiting membrane peeling with and/or without indocyanine green, and postoperative posturing. RESULTS: The duration of preoperative symptoms, indocyanine green-assisted internal limiting membrane peeling, hole stage, and better preoperative visual acuity were associated with both anatomical success and regaining a postoperative visual acuity of 6/12 or better. DISCUSSION: The closure rate in patients undergoing surgery within 1 year of onset was 94.0%, and in those waiting 1 year or more it was 47.4%. Clinical governance and quality issues should dictate that NHS macular hole surgery is available to all within 1 year of onset. This study showed no adverse effect of ICG dye retinal staining. The results support the use of a 'patient-friendly' approach of simultaneous cataract surgery with no prone postoperative posturing.

A randomised controlled feasibility trial of vitrectomy versus laser for diabetic macular oedema.

AIM: (1) To evaluate whether vitrectomy is preferable to further macular laser in improving visual acuity and resolving retinal thickening in patients with diabetic macular oedema (DMO) despite previous laser and no macular traction. (2) To determine the feasibility of further trials in this population in terms of magnitude of comparative clinical effect, rate of recruitment, and loss to follow up. METHODS: A randomised controlled feasibility study. Patients with DMO and a visual acuity of 0.3 logMAR (6/12) or worse after one or more macular laser treatments were randomised on a 1:1 basis to either pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling or further macular laser. Patients with a posterior vitreous detachment, biomicroscopic evidence of retinal traction, or a taut thickened posterior hyaloid (TTPH) were excluded. Primary outcome measures were (1) best corrected logMAR visual acuity, (2) mean central macular thickness on optical coherence tomography, and (3) rate of recruitment and loss to follow up. Analysis was on an intention to treat basis. RESULTS: 19 patients were randomised to PPV and 21 to further macular laser. The mean baseline logMAR visual acuity was 0.65 (SD 0.28) for the group randomised to PPV and 0.60 (0.23) for the group randomised to laser. The mean change in best corrected visual acuity of the vitrectomy group was deterioration by 0.05 logMAR, while in the control group the mean change was an improvement of 0.03 logMAR. The median (interquartile range) baseline central macular thickness was 403 (337, 492) for the group randomised to PPV and 387 (298, 491) for the controls randomised to laser. The median change in central macular thickness from baseline to review in the vitrectomy group was a thinning by 73 mum (20%) and by 29 mum (10.7%) in the control laser group. This single centre was able to recruit 40 patients in 18 months with follow up of 82% at 1 year. CONCLUSION: A randomised controlled trial was found to be potentially feasible in this population, the rate of recruitment was however slow and one in five patients were lost to follow up because of death and ill health. These data provide little evidence in terms of visual acuity and macular thickness of any benefit of vitrectomy over further macular laser in patients with an attached hyaloid, DMO despite previous laser, and no clinically evident macular traction or TTPH.

Development of a clinically feasible logMAR alternative to the Snellen chart: performance of the "compact reduced logMAR" visual acuity chart in amblyopic children.

BACKGROUND/AIM: The "compact reduced logMAR" (cRLM) chart is being developed as a logMAR alternative to the Snellen chart. It is closer spaced and has fewer letters per line than conventional logMAR charts. Information regarding the performance of such a chart in amblyopes and children is therefore required. This study aimed to investigate the performance of the cRLM chart in amblyopic children. METHODS: Timed test and retest measurements using two versions of each chart design were obtained on the amblyopic eye of 43 children. Using the methods of Bland and Altman the agreement, test-retest variability (95% confidence limits for agreement, TRV) and test time of the cRLM and the current clinical standard Snellen chart were compared to the gold standard ETDRS logMAR chart. RESULTS: No systematic bias between chart designs was found. For line assignment scoring the respective TRVs were 0.20 logMAR, 0.20 logMAR, and 0.30 logMAR. Single letter scoring TRVs were cRLM (95% CL 0.17) logMAR, ETDRS (95% CL 0.14) logMAR, and Snellen (95% CL 0.29) logMAR. Median testing times were ETDRS 60 seconds, cRLM 40 seconds, Snellen 30 seconds. CONCLUSION: The sensitivity to change of the cRLM equalled or approached that of the gold standard ETDRS and was at least 50% better than that of Snellen. This enhanced sensitivity to change was at the cost of only a 10 second time penalty compared to Snellen. The cRLM chart was approximately half the width of the ETDRS chart. The cRLM chart may represent a clinically acceptable compromise between the desire to obtain logMAR acuities of reasonable and known sensitivity to change, chart size, and testing time.

Improving on ETDRS acuities: design and results for a computerised thresholding device.

AIMS: All visual acuity data are subject to test-retest variability (TRV). This measurement error obscures true clinical change and reduces the statistical power of clinical trials using acuity as a primary outcome measure. This study was designed to assess whether a computerised system can reduce TRV by taking repeated acuity measurements and averaging them. A computerised system (PC-test) was developed for this purpose and compared in terms of TRV with the current Gold Standard ETDRS logMAR chart. METHODS: A total of 19 subjects with a mean acuity of +0.16 logMAR (range +0.49 to -0.10 logMAR) were recruited. The performance of two computerised tests (one averaging 10 repeats and one five) was compared with that of the ETDRS logMAR chart in terms of TRV and agreement of acuity data. Results The 10 and five repeat computerised tests (PC-tests) produced a TRV of +/-0.11 and +/-0.10 logMAR, respectively, compared with +/-0.18 logMAR for the ETDRS chart. No significant bias was observed between PC-test and ETDRS acuities. CONCLUSIONS: A computerised system that takes repeated acuity measurements and averages them is subject to less TRV than a single ETDRS acuity measurement. A reduced TRV of visual acuity data allows earlier detection of true clinical change in individual patients. It also allows smaller differences between groups to be detected in clinical trials for a given degree of statistical confidence and power.