Randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery following open globe trauma: The ASCOT study.

BACKGROUND/AIMS: To investigate the clinical effectiveness of adjunctive triamcinolone acetonide (TA) given at the time of vitreoretinal surgery following open globe trauma (OGT). METHODS: A phase 3, multicentre, double-masked randomised controlled trial of patients undergoing vitrectomy following OGT comparing adjunctive TA (intravitreal and subtenons) against standard care (2014-2020). The primary outcome was the proportion of patients with at least 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letter improvement in corrected visual acuity (VA) at 6 months. Secondary outcomes included: change in ETDRS, retinal detachment (RD) secondary to PVR, retinal reattachment, macular reattachment, tractional RD, number of operations, hypotony, elevated intraocular pressure and quality of life. RESULTS: 280 patients were randomised over 75 months, of which 259 completed the study. 46.9% (n=61/130) of patients in the treatment group had a 10-letter improvement in VA compared with 43.4% (n=56/129) of the control group (difference 3.5% (95% CI -8.6% to 15.6%), OR=1.03 (95% CI 0.61 to 1.75), p=0.908)). Secondary outcome measures also failed to show any treatment benefit. For two of the secondary outcome measures, stable complete retinal and macular reattachment, outcomes were worse in the treatment group compared with controls, respectively, 51.6% (n=65/126) vs 64.2% (n=79/123), OR=0.59 (95% CI 0.36 to 0.99), and 54.0% (n=68/126) vs 66.7% (n=82/123), OR=0.59 (95% CI 0.35 to 0.98), for TA vs control. CONCLUSION: The use of combined intraocular and sub-Tenons capsule TA is not recommended as an adjunct to vitrectomy surgery following OGT. TRIAL REGISTRATION NUMBER: NCT02873026.

Presenting clinical characteristics of open globe injuries in ocular trauma: baseline analysis of cases in the ASCOT national clinical trial.

BACKGROUND/OBJECTIVES: The Adjunctive Steroid Combination in Ocular Trauma (ASCOT) trial is a unique pragmatic, multi-centre, patient and assessor masked, randomised controlled trial. We evaluate the clinical characteristics and pathology of this large trial cohort of patients with open globe injuries undergoing vitreoretinal surgery, including the associations between patient characteristics and their baseline vision. SUBJECTS/METHODS: We (i) summarise demographics, injury history and ocular history of the 280 participants recruited into the ASCOT trial using descriptive statistics; (ii) analyse the national and seasonal variation across England and Scotland in these participant characteristics; and (iii) explore the associations between participant demographic, trauma history, ocular history and presenting baseline visual acuity (measured using the Early Treatment Diabetic Retinopathy Study, ETDRS) using multivariable regression analyses. RESULTS: The majority of participants with open globe penetrating injuries were of white ethnicity (233, 84%), male (246, 88%), with a median age of 43 years (IQR 30-55 years). There was considerable variability in presenting visual acuity with 75% unable to read any letters on the ETDRS chart, whilst the median ETDRS letter score was 58 (IQR 24-80) for those who could read ≥1 letter. The most common causes of injury were workplace related (31%) or interpersonal violence (24%). Previous eye surgery, visual axis corneal scar, lens status, hyphaemia and vitreous haemorrhaging were found to be associated with presenting vision as measured by the ETDRS chart. CONCLUSION: The ASCOT trial provides valuable insights into the spectrum of pathology of patients with open globe eye injuries undergoing vitreoretinal surgery. The identified causes of injury and clinical presentation of the cases will help in training and resource planning to deal with these often challenging surgical cases. TRIAL REGISTRATION: EudraCT No. 014-002193-37. HTA Project 12/35/64.

Maculopathy Masquerading as Migraine.

We describe a case of a 23-year-old Caucasian woman with a background history of migraines who presented with bilateral paracentral scotomata. The ophthalmoscopy and MRI head were originally thought to be normal, and the scotomata were attributed to be of migrainous origin: a persistent negative aura. However, persistence of her symptoms prompted further specialist review 10 months later, at which time subtle bilateral perifoveal changes were noted, which had been apparent but overlooked at the initial assessment. Near-infrared reflectance imaging enabled better visualization of the lesions, which were apparent prior to any abnormalities on clinical examination. Spectral-domain optical coherence tomography revealed the early findings of hyperreflectivity in the outer nuclear and outer plexiform layers characteristic of acute macular neuroretinopathy. Our case aims to emphasize the importance of scrutinising ancillary tests of the macula in patients presenting with scotomata or atypical migraine symptoms, and to caution clinicians against diagnosing migraine with persistent negative aura without these investigations.

Trapped Pre-Macular Bubble of Octafluoropropane Gas Masquerading as Retained Submacular Perfluorocarbon Liquid.

INTRODUCTION: To demonstrate, with the aid of retinal imaging, an abnormal post-operative macular appearance caused by the presence of a "fragmented" pre-retinal bubble of octafluoropropane (C3F8) masquerading as retained subretinal perfluorocarbon liquid (PFCL). METHODS: This is an interventional case presentation. RESULTS: Colour fundus photography high-resolution spectral domain-optical coherence tomography (SD-OCT) and clinical progress demonstrate that the abnormal reflex was caused by the presence of a small fragment of C3F8 becoming lodged at the pre-foveal area. CONCLUSION: Submacular entrapment of various substances used during vitrectomy has been described in a number of case reports and case series. To our knowledge, this is the first described case of a retained fragment of fluorocarbon gas trapped at the macula following successful retinal detachment repair and highlights a previously unreported cause of an abnormal foveal appearance. However, clinical examination together with the use of SD-OCT is helpful in differentiating the appearance from that seen in other retained vitrectomy adjuncts.

Pars Plana Vitrectomy for Vitreomacular Traction Syndrome: Analysing the Preoperative Prognostic Factors.

PURPOSE: To identify the prognostic factors affecting the surgical outcomes in patients with vitreomacular traction syndrome undergoing pars plana vitrectomy. METHODS: This was a retrospective clinical study of 67 eyes of 67 patients with vitreomacular traction syndrome who underwent pars plana vitrectomy. Demographic, clinical, and optical coherence tomography (OCT) characteristics were collected and analyzed. Univariate and multivariate linear regression analysis were used to examine the effect of parameters on change in best-corrected visual acuity (BCVA). RESULTS: At a mean follow-up period of 15.9±12 months (mean±SD), the BCVA improved from 0.7±0.3 LogMAR (mean±SD) to 0.5±0.3. Seven patients developed full-thickness macular hole intraoperatively and tamponade (air, 20% SF6 or 12% C3F8) was used in 41 patients. Retinal breaks were identified intraoperatively in four patients. Regression analysis demonstrated that the preoperative BCVA was the only parameter affecting the postoperative visual outcome. CONCLUSION: In the present study, the preoperative BCVA plays a predictive role in the surgical outcome of patients with VMT undergoing pars plana vitrectomy. No other preoperative OCT characteristics demonstrated prognostic potential. Further prospective studies are needed in order to examine the role of several factors that could potentially facilitate preoperative patient counselling.

Slow-Release Dexamethasone in Proliferative Vitreoretinopathy: A Prospective, Randomized Controlled Clinical Trial.

PURPOSE: To test the hypothesis that adjunctive slow-release dexamethasone implant (Ozurdex; Allergan Inc, Irvine, CA) can improve the outcomes of vitreoretinal surgery for established proliferative vitreoretinopathy (PVR). DESIGN: A 2-year, single-center, prospective, participant- and surgeon-masked randomized controlled clinical trial (EudraCT No. 2011-004498-96). PARTICIPANTS: A total of 140 patients requiring vitrectomy surgery with silicone oil for retinal detachment with established PVR (Grade C) were randomized to standard (control) or study treatment (adjunct) in a 1:1 allocation ratio. METHODS: Intraoperatively, the adjunct group received an injection of 0.7 mg of slow-release dexamethasone (Ozurdex) at the time of (1) vitrectomy surgery and (2) silicone oil removal. The control group received standard care. MAIN OUTCOME MEASURES: Primary outcome measure was the proportion of patients with a stable retinal reattachment with removal of silicone oil without additional vitreoretinal surgical intervention at 6 months. Secondary outcomes included (1) final visual acuity (VA) (median and Early Treatment Diabetic Retinopathy Study [ETDRS] of 55 letters or better); (2) cystoid macular edema (CMO), foveal thickness, and macular volume; (3) development of overt PVR recurrence; (4) complete and posterior retinal reattachment; (5) tractional retinal detachment; (6) hypotony/increased intraocular pressure (IOP); (7) macula pucker/epiretinal membrane; (8) cataract; and (9) quality of life. RESULTS: All 140 patients were recruited within 25 months of study commencement; 138 patients had primary outcome data. Primary outcome assessment showed similar results in anatomic success between the 2 groups (49.3% vs. 46.3%, adjunct vs. control; odds ratio, 0.89; 95% confidence interval, 0.46-1.74; P = 0.733). Mean VA at 6 months was 38.3 ETDRS letters and 40.2 letters in the adjunct and control groups, respectively. Secondary anatomic outcomes (complete/posterior reattachment rates and PVR recurrence) were comparable between the 2 groups. At 6 months, fewer adjunct patients had CMO (42.7%) or a foveal thickness of >300 µm (47.6%) compared with controls (67.2% and 67.7%, respectively, P = 0.004, P = 0.023). CONCLUSIONS: A slow-release dexamethasone implant did not improve the primary anatomic success rate in eyes undergoing vitrectomy surgery with silicone oil for PVR. Further clinical trials are indicated to improve anatomic and visual outcomes in these eyes, but this study suggests that there is a greater reduction in CMO observed at 6 months in vitrectomized eyes treated with slow-release dexamethasone.

Characteristics and vitreoretinal management of retinal detachment in eyes with Boston keratoprosthesis.

PURPOSE: To review the incidence and features of vitreoretinal complications of a permanent Boston keratoprosthesis and to report the use and outcomes of 23-gauge vitrectomy to manage vitreoretinal pathology. DESIGN: Retrospective non-comparative, interventional case series. SUBJECT, PARTICIPANTS: 27 eyes of 27 patients managed with a Boston keratoprosthesis at Moorfields Eye Hospital over a 3-year period. METHODS: All eyes that underwent pars plana vitrectomy (PPV) and had at least 6 months follow-up were analysed with a specific focus on the anatomical and histological characteristics of retinal detachment and outcomes of surgery. MAIN OUTCOME MEASURES: Anatomical success and characteristics of retinal detachment over the follow-up period. RESULTS: 27 patients underwent Boston keratoprosthesis implantation over the study period. Of these, six (22%) required PPV for retinal detachment which demonstrated a specific pattern of serous elevation with subsequent severe anterior proliferative vitreoretinopathy (PVR). The mean follow-up period was 9 months (range 6-14 months). At final follow-up, visual acuity ranged from perception of light to 6/18, and five of six cases had attached retinae under the silicone oil. Histological analysis of a subretinal membrane demonstrated a predominantly glial/retinal pigment epithelium fibrocellular tissue, consistent with PVR. CONCLUSIONS: The study showed that retinal detachment complicated by PVR, as demonstrated by the clinical and histological characteristics of this condition, is common in patients undergoing Boston keratoprosthesis. We also showed that 23-gauge vitrectomy can be effectively performed in patients with a permanent prosthesis. Visual acuity often remains poor, despite successful anatomical results.

SPONTANEOUS CLOSURE OF MACULAR HOLE AFTER DRAINAGE OF SUBFOVEAL PERFLUOROCARBON LIQUID.

PURPOSE: To report a rare case of macular hole formation after drainage of subretinal perfluorocarbon liquid (PFCL), which closed spontaneously. METHODS: Retrospective case report. A 60-year-old was noted to have subfoveal PFCL after a macula-involving retinal detachment repair with silicone oil tamponade. Spectral domain optical coherence tomography (Spectralis; Heidelberg Engineering, Heidelberg, Germany) was used for postoperative imaging. RESULTS: Two months postdetachment repair, the patient underwent removal of silicone oil and drainage of subfoveal PFCL using a 41-gauge cannula through a extrafoveal retinotomy. A full-thickness macular hole was noted 2 weeks postoperatively. This closed spontaneously 4 months later, with an improvement in vision, although there was evidence of subfoveal atrophy. CONCLUSION: Macular hole formation can occur after drainage of subfoveal PFCL, with a favorable prognosis if managed conservatively. The resultant foveal atrophy highlights the importance of early identification and removal of subretinal PFCL.

Adjunctive intraocular and peri-ocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma (ASCOT): study protocol for a phase III, multi-centre, double-masked randomised controlled trial.

BACKGROUND: Eyes sustaining open globe trauma are at high risk of severe visual impairment. Ocular injuries which result in visual loss invariably affect the posterior segment of the eye, and prevention of visual loss involves posterior segment (vitreoretinal) surgery. Despite improvements in vitreoretinal surgical techniques, outcomes in these patients remain unsatisfactory, and development of the intraocular scarring response proliferative vitreoretinopathy is the leading cause. Proliferative vitreoretinopathy is the most common cause of recurrent retinal detachment in these eyes; it is reported to occur in up to 45 % of cases. METHODS/DESIGN: The Adjunctive Steroid Combination in Ocular Trauma (ASCOT) trial is a multi-centre, double-masked, parallel-arm randomised controlled trial with an internal pilot designed to investigate the effectiveness and cost-effectiveness of using intravitreal and sub-Tenon's triamcinolone acetonide peri-operatively in patients undergoing vitrectomy following open globe trauma. In total, 300 eyes of 300 patients will be recruited and randomly allocated to one of two treatment groups. Both groups will receive standard surgical treatment and routine pre-operative and post-operative treatment and care. The treatment group will receive an adjunctive peri-operative steroid combination (triamcinolone acetonide) consisting of 4 mg/0.1 ml into the vitreous cavity and 40 mg/1 ml into the sub-Tenon's space. The trial incorporates a two-stage internal pilot to examine projected recruitment and retention rates. Progression criteria from the internal pilot study will enable us to determine whether to undertake the main trial. Patients and primary outcome assessors will be masked to treatment allocation. The primary outcome will be an improvement from baseline to 6 months of at least 10 on the corrected visual acuity as measured by ETDRS letter score. Secondary outcomes will be development of scarring, retinal detachment, intraocular pressure abnormalities, quality of life and public sector service use. DISCUSSION: This is the first powered, controlled clinical trial to investigate the use of adjunctive triamcinolone in patients undergoing vitrectomy following open globe trauma. TRIAL REGISTRATION: EudraCT2014-002193-37 . Registered on 5 September 2014. ISRCTN30012492 . Registered on 5 September 2014.

Long-Term Survival Rates of Patients Undergoing Vitrectomy for Proliferative Diabetic Retinopathy.

PURPOSE: Reported 5-year survival rates in patients undergoing vitreous surgery for proliferative diabetic retinopathy (PDR) range from 68-95%. Studies relating survival rates to medical baseline characteristics predate the millennium. This study aimed to update data on life expectancy of patients undergoing vitrectomy for PDR and identify baseline factors which may influence survival. METHODS: A retrospective cohort study of consecutive patients who underwent their first pars-plana vitrectomy for PDR between April 2004 and May 2005 was performed. Survival status on 1 May 2012 was the primary endpoint. The Kaplan-Meier life table method was used to determine survival rates. Univariate and multiple variable Cox proportional hazards regressions were used to identify risk factors for mortality. RESULTS: A total of 148 patients were included in the study, with a mean age of 54 years (range 20-80 years) at time of surgery. The 3-, 5- and 7-year survival rates were 94%, 86% and 77%, respectively (95% confidence interval, CI, 88-97%, 79-91% and 68-84%, respectively). Renal failure was the most common cause of death. The presence of limb ulcers at baseline was the most important prognostic indicator for mortality, with a hazard ratio of 3.13 (95% CI 1.46-6.71, p = 0.003) and a survival rate at 5 years reduced to 79%. CONCLUSION: The 5-year survival rate remains comparable to those reported 20 years ago despite a lowering in threshold for vitrectomy and increased health awareness. Limb ulcers are strongly associated with increasing mortality. Clinicians should remain mindful of the systemic associations of diabetes particularly in advanced retinal disease.

Triamcinolone during pars plana vitrectomy for open globe trauma: a pilot randomised controlled clinical trial.

PURPOSE: To investigate the feasibility of conducting a randomised controlled trial in patients undergoing pars plana vitrectomy surgery following open globe trauma (OGT). Additionally, to investigate the treatment effect and toxicity of intensive anti-inflammatory agents. METHODS: A 2-year, pilot, single-centre prospective, participant and surgeon-masked randomised controlled trial (RCT). Forty patients requiring vitrectomy surgery following OGT were randomised to either standard (control) or study treatment (adjuncts) in a 1:1 allocation ratio. Perioperatively, the adjunct group received intravitreal and subtenons triamcinolone acetonide, oral flurbiprofen and guttae prednisolone acetate 1%. The control group received standard care. Primary outcome was anatomical success at 6 months. Secondary outcomes included final visual acuity, occurrence of proliferative vitreoretinopathy, intraocular pressure rise, number of operations and recruitment rate. RESULTS: 40 patients were recruited within 21 months. Primary outcome assessment showed similar results in anatomical success with 50% (10/20) in the adjunct group compared with 47% (9/19) in the standard group (OR 1.11, 95% CI 0.316 to 3.904). Visual outcomes were better in the adjunct group with a final median visual acuity of 31 Early Treatment Diabetic Retinopathy Study (ETDRS) letters compared with 25 ETDRS letters in the standard group. A higher proportion of patients gained 10, 20 and 30 ETDRS letters in the adjunct group (80%, 65% and 50%, respectively) compared with the standard group (52.6%, 52.6% and 42.1%). Fewer adjunct patients (15%, n=3) had poor visual outcomes (Zero ETDRS letters) compared with 42.1%, (n=8). CONCLUSIONS: An RCT in this population is deliverable and estimated recruitment rates are realistic. Results and patient discussions determined that the definitive study should have vision as a primary outcome. This pilot study is supportive of there being a positive treatment effect of intensive anti-inflammatory agents in OGT. TRIAL REGISTRATION NUMBER: European Clinical Trials Database 2007-005138-35; Results.

Neurotrophic corneal ulceration after retinal detachment surgery with retinectomy and endolaser: a case series.

IMPORTANCE: Trigeminal nerve lesions at differing levels can result in complete or partial corneal anesthesia and ensuing epithelial breakdown. Disease progression can lead to corneal ulceration, melt, and perforation. To our knowledge, neurotrophic corneal ulceration has not previously been reported after retinal detachment surgery and argon endolaser. OBSERVATION: Herein, we report a series of 5 cases of patients without diabetes who developed neuropathic corneal ulceration presumed secondary to long ciliary nerve compromise. This occurred within 5 to 10 weeks following vitrectomy surgery with endolaser and silicone oil tamponade for retinal detachment. CONCLUSIONS AND RELEVANCE: Clinicians should be mindful of the long ciliary nerves intraoperatively and, where possible, avoid heavy confluent treatment at these sites without compromising the need for adequate retinopexy. Where corneal anesthesia occurs, it is important to recognize this early and treat promptly to minimize the risk for ulceration and visual loss.

Ozurdex (a slow-release dexamethasone implant) in proliferative vitreoretinopathy: study protocol for a randomised controlled trial.

BACKGROUND: Proliferative vitreoretinopathy (PVR) is the commonest cause of late anatomical failure in rhegmatogenous retinal detachment. Visual and anatomical outcomes remain poor despite advances in vitreoretinal surgical techniques with reported primary failure rates of up to nearly 50%. Numerous adjunctive medications have been evaluated in clinical trials with no agent gaining widespread acceptance and use.This study was designed to investigate the benefits of using a slow-release dexamethasone implant delivered intra-operatively in patients undergoing vitrectomy surgery for retinal detachment with established PVR. METHODS/DESIGN: For the study, 140 patients requiring vitrectomy surgery with silicone oil for retinal detachment with established PVR will be randomised to receive either standard treatment or study treatment in a 1:1 treatment allocation ratio. Both groups will receive the standard surgical treatment appropriate for their eye condition and routine peri-operative treatment and care, differing only in the addition of the supplementary adjunctive agent in the treatment group. The investigated primary outcome measure is stable retinal reattachment with removal of silicone oil without additional vitreoretinal surgical intervention at 6 months. DISCUSSION: This is the first randomised controlled clinical trial to investigate the use of an adjunctive slow-release dexamethasone implant in patients undergoing vitrectomy surgery for retinal detachments with proliferative vitreoretinopathy. TRIAL REGISTRATION: EudraCT No: 2011-004498-96.