The United Kingdom Diabetic Retinopathy Electronic Medical Record Users Group: Report 3: Baseline Retinopathy and Clinical Features Predict Progression of Diabetic Retinopathy.

PURPOSE: To determine the time and risk factors for developing proliferative diabetic retinopathy (PDR) and vitreous hemorrhage (VH). DESIGN: Multicenter, national cohort study. METHODS: Anonymized data of 50 254 patient eyes with diabetes mellitus at 19 UK hospital eye services were extracted at the initial and follow-up visits between 2007 and 2014. Time to progression of PDR and VH were calculated with Cox regression after stratifying by baseline diabetic retinopathy (DR) severity and adjusting for age, sex, race, and starting visual acuity. RESULTS: Progression to PDR in 5 years differed by baseline DR: no DR (2.2%), mild (13.0%), moderate (27.2%), severe nonproliferative diabetic retinopathy (NPDR) (45.5%). Similarly, 5-year progression to VH varied by baseline DR: no DR (1.1%), mild (2.9%), moderate (7.3%), severe NPDR (9.8%). Compared with no DR, the patient eyes that presented with mild, moderate, and severe NPDR were 6.71, 14.80, and 28.19 times more likely to develop PDR, respectively. In comparison to no DR, the eyes with mild, moderate, and severe NPDR were 2.56, 5.60, and 7.29 times more likely to develop VH, respectively. In severe NPDR, the eyes with intraretinal microvascular abnormalities (IRMA) had a significantly increased hazard ratio (HR) of developing PDR (HR 1.77, 95% confidence interval [CI] 1.25-2.49, P = .0013) compared with those with venous beading, whereas those with 4-quadrant dot-blot hemorrhages (4Q DBH) had 3.84 higher HR of developing VH (95% CI 1.39-10.62, P = .0095). CONCLUSIONS: Baseline severities and features of initial DR are prognostic for PDR development. IRMA increases risk of PDR whereas 4Q DBH increases risk of VH.

The UK Diabetic Retinopathy Electronic Medical Record (UK DR EMR) Users Group, Report 2: real-world data for the impact of cataract surgery on diabetic macular oedema.

AIM: To assess the rate of 'treatment-requiring diabetic macular oedema (DMO)' in eyes for the two years before and after cataract surgery. METHODS: Multicentre national diabetic retinopathy (DR) database study with anonymised data extraction across 19 centres from an electronic medical record system. INCLUSION CRITERIA: eyes undergoing cataract surgery in patients with diabetes with no history of DMO prior to study start. The minimum dataset included: age, visual acuity (all time-points), injection episodes, timing of cataract surgery and ETDRS grading of retinopathy and maculopathy. MAIN OUTCOME MEASURE: rate of developing first episode of treatment-requiring DMO in relation to timing of cataract surgery in the same eye. RESULTS: 4850 eyes met the inclusion criteria. The rate of developing treatment-requiring DMO in this cohort was 2.9% in the year prior to surgery versus 5.3% in the year after surgery (p<0.01). The risk of 'treatment-requiring DMO' increased sharply after surgery, peaking in the 3-6 months' period (annualised rates of 5.2%, 6.8%, 5.6% and 4.0% for the 0-3, 3-6, 6-9 and 9-12 months' post-operative time periods respectively). Risk was associated with pre-operative grade of retinopathy: risk of DMO in the first year post-operatively being 1.0% (no DR pre-operatively), 5.4% (mild non-proliferative diabetic retinopathy; NPDR), 10.0% (moderate NPDR), 13.1% (severe NPDR) and 4.9% (PDR) (p<0.01). CONCLUSIONS: This large real-world study demonstrates that the rate of developing treatment-requiring DMO increases sharply in the year after cataract surgery for all grades of retinopathy, peaking in the 3-6 months' postoperative period. Patients with moderate and severe NPDR are at particularly high risk.

The United Kingdom Diabetic Retinopathy Electronic Medical Record Users Group, Report 1: baseline characteristics and visual acuity outcomes in eyes treated with intravitreal injections of ranibizumab for diabetic macular oedema.

AIMS: To describe baseline characteristics and visual outcome for eyes treated with ranibizumab for diabetic macular oedema (DMO) from a multicentre database. METHODS: Structured clinical data were anonymised and extracted from an electronic medical record from 19 participating UK centres: age at first injection, ETDRS visual acuity (VA), number of injections, ETDRS diabetic retinopathy (DR) and maculopathy grade at baseline and visits. The main outcomes were change in mean VA from baseline, number of injections and clinic visits and characteristics affecting VA change and DR grade. RESULTS: Data from 12 989 clinic visits was collated from baseline and follow-up for 3103 eyes. Mean age at first treatment was 66 years. Mean VA (letters) for eyes followed at least 2 years was 51.1 (SD=19.3) at baseline, 54.2 (SD: 18.6) and 52.5 (SD: 19.4) at 1 and 2 years, respectively. Mean visual gain was five letters. The proportion of eyes with VA of 72 letters or better was 25% (baseline) and 33% (1 year) for treatment naïve eyes. Eyes followed for at least 6 months received a mean of 3.3 injections over a mean of 6.9 outpatient visits in 1 year. CONCLUSIONS: In a large cohort of eyes with DMO treated with ranibizumab injections in the UK, 33% of patients achieved better than or equal to 6/12 in the treated eye at 12 months compared with 25% at baseline. The mean visual gain was five letters. Eyes with excellent VA at baseline maintain good vision at 18 months.

UK AMD EMR USERS GROUP REPORT V: benefits of initiating ranibizumab therapy for neovascular AMD in eyes with vision better than 6/12.

BACKGROUND/AIMS: To study the effectiveness and clinical relevance of eyes treated with good (better than 6/12 or >70 Early Treatment Diabetic Retinopathy Study letters) visual acuity (VA) when initiating treatment with ranibizumab for neovascular age-related macular degeneration (nAMD) in the UK National Health Service. Currently eyes with VA better than (>) 6/12 are not routinely funded for therapy. METHODS: Multicentre national nAMD database study on patients treated 3-5 years prior to the analysis. Anonymised structured data were collected from 14 centres. The primary outcome was the mean VA at year 1, 2 and 3. Secondary measures included the number of clinic visits and injections. RESULTS: The study included 12 951 treatment-naive eyes of 11 135 patients receiving 92 976 ranibizumab treatment episodes. A total of 754 patients had baseline VA better than 6/12 and at least 1-year of follow up. Mean VA of first treated eyes with baseline VA>6/12 at year 1, 2, 3 were 6/10, 6/12, 6/15, respectively and those with baseline VA 6/12 to >6/24 were 6/15, 6/17, 6/20, respectively (p values <0.001 for comparing differences between 6/12 and 6/12-6/24 groups). For the second eyes with baseline VA>6/12, mean VA at year 1, 2, 3 were 6/9, 6/9, 6/10 and those with baseline VA 6/12 to >6/24 were 6/15, 6/15, 6/27, respectively (p values <0.001-0.005). There was no significant difference in the average number of clinic visits or injections between those with VA better and worse than 6/12. CONCLUSIONS: All eyes with baseline VA>6/12 maintained better mean VA than the eyes with baseline VA 6/12 to >6/24 at all time points for at least 2 years. The significantly better visual outcome in patients who were treated with good baseline VA has implications on future policy regarding the treatment criteria for nAMD patients' funding.

The neovascular age-related macular degeneration database: report 2: incidence, management, and visual outcomes of second treated eyes.

PURPOSE: To study the characteristics of second treated eyes in patients with neovascular age-related macular degeneration (nAMD) treated with ranibizumab in the United Kingdom National Health Service. DESIGN: Multicenter national nAMD database study. PARTICIPANTS: Twelve thousand nine hundred fifty-one treatment-naïve eyes of 11,135 patients receiving 92,976 ranibizumab injections. METHODS: Up to 5 years of routinely collected, anonymized data within electronic medical record systems were extracted remotely from 14 centers. Participating centers exclusively used ranibizumab to treat nAMD (loading phase of 3 monthly injections followed by monthly visits and pro re nata re-treatment). The minimum data set included: age, logarithm of the minimum angle of resolution (logMAR) visual acuity (VA) at baseline and at all subsequent visits, and injection episodes. MAIN OUTCOME MEASURES: Baseline, change and actual VA over 3 years, and number of treatments and clinic visits. RESULTS: During the study, 1816 (16.3%) of the 11 135 patients received treatment to the fellow eye. Mean baseline and final VA were 0.66 (standard deviation, 0.32) and 0.65 (0.40) for first treated eyes and 0.41 (0.34) and 0.56 (0.40) for second treated eyes. The rate of VA loss after the loading phase was similar in first and second treated eyes (0.03 and 0.05 logMAR units/year). When fellow eyes with baseline VA worse than 20/200 were excluded to restrict analyses to eyes at risk of nAMD, the rate of second-eye involvement was 14.0% per year (42%/3 years). Mean number of injections/visits in years 1, 2, and 3 were similar for first and second treated eyes (5.6/8.2, 3.9/8.0, 3.8/8.2 and 5.5/8.7, 3.6/9.4, and 3.8/9.1, respectively). CONCLUSIONS: Second treated eyes with nAMD commence treatment with better baseline VA, do not show significant vision gain but maintain better VA than first treated eyes at all time points for at least 3 years, making them the more important eye functionally. These data highlight the high burden of second eye involvement, with almost half of all eyes at risk requiring bilateral treatment by 3 years, and the need for regular monitoring of fellow eyes for best visual outcomes which theoretically may reduce the benefits of extended monitoring regimens.

Visual and refractive outcome of one-site phacotrabeculectomy compared with temporal approach phacoemulsification.

BACKGROUND: We aimed to compare visual and refractive outcome following phacoemulsification and intraocular lens implant (IOL) and combined one-site phacotrabeculectomy. METHOD: We performed a retrospective study of case records of patients who had temporal incision phacoemulsification with IOL or one-site phacotrabeculectomy, between June 1997 and June 2001. The patients were matched for age group, operating list and IOL type. All patients were operated on under local anesthesia by the same surgeon. Each arm of the study had 90 patients, age range 60 to 75 years. We collected pre- and postoperative visual acuity, pre- and postoperative refraction within six months after surgery, and intended refraction. The intraocular pressure control was not recorded, as it was not the aim of our study. RESULTS: In the phacotrabeculectomy group, 76.6% of patients achieved aimed spherical equivalent, 15.5% of patients had against-the-rule (ATR) astigmatism induced by the surgery, and 90% of the patients had best corrected visual acuity (BCVA) more than 6/12. In the temporal incision phacoemulsification group, 81.1% of patients achieved aimed spherical equivalent, 10% of the patients had induced ATR by the surgery and 95.55% of patients achieved BCVA more than 6/12. CONCLUSION: In this study the visual outcome of the phacotrabeculectomy group did not differ significantly from the visual outcome of temporal approach phacoemulsification.

Painful vertical diplopia as a presentation of a pituitary mass.

BACKGROUND: Pituitary tumours may present with a variety of neurological and endocrinological signs and symptoms. It is very rare however for them to present with sudden onset painful diplopia. The current literature and possible mechanisms for this are discussed. CASE PRESENTATION: We describe a case of a pituitary mass which presented with sudden onset painful diplopia with an associated restricted pattern on Lees Chart testing. This led to an initial working diagnosis of orbital myositis. CONCLUSION: Awareness of different modes of presentation of pituitary lesions is important so that appropriate imaging may be requested and delay in diagnosis prevented.

Is post-trabeculectomy hypotony a risk factor for subsequent failure? A case control study.

BACKGROUND: Ocular hypotony results in an increased break down of the blood-aqueous barrier and an increase in inflammatory mediator release. We postulate that this release may lead to an increased risk of trabeculectomy failure through increased bleb scarring. This study was designed to try to address the question if hypotony within one month of trabeculectomy for Primary Open Angle Glaucoma (POAG), is a risk factor for future failure of the filter. METHODS: We performed a retrospective, case notes review, of patients who underwent trabeculectomy for POAG between Jan 1995 and Jan 1996 at our hospital. We identified those with postoperative hypotony within 1 month of surgery. Hypotony was defined as an intraocular pressure (IOP) < 8 mmHg or an IOP of less than 10 mmHg with choroidal detachment or a shallow anterior chamber. We compared the survival times of the surgery in this group with a control group (who did not suffer hypotony as described above), over a 5 year period. Failure of trabeculectomy was defined as IOP > 21 mmHg, or commencement of topical antihypertensives or repeat surgery. RESULTS: 97 cases matched our inclusion criteria, of these 38 (39%) experienced hypotony within 1 month of surgery. We compared the survival times in those patients who developed hypotony with those who did not using the log-rank test. This data provided evidence of a difference (P = 0.0492) with patients in the hypotony group failing more rapidly than the control group. CONCLUSION: Early post-trabeculectomy hypotony (within 1 month) is associated with reduced survival time of blebs.

Investigation into postoperative endophthalmitis and lessons learned.

PURPOSE: To describe an approach to the investigation of a series of endophthalmitis cases to determine whether there was a true outbreak. SETTING: Outpatient facility, Sunderland, England. METHODS: Different approaches to statistical analysis of the probability of infrequent events being due to chance occurrence are described. Potential factors leading to an outbreak were reviewed. RESULTS: Bayesian statistical analysis was shown to be appropriate in the determination of an endophthalmitis outbreak. The only factor found to account for the outbreak was the operating surgeon's recent abandonment of subconjunctival antibiotic prophylaxis. This decision was based on the absence of good evidence that subconjunctival antibiotic injection is effective in prophylaxis. These endophthalmitis cases demonstrate that the absence of evidence for effect is not the same as there being no effect. CONCLUSIONS: Bayesian statistical analysis has a place in determining whether an outbreak has occurred. Withdrawing treatment simply on the basis of a lack of good evidence can lead to undesirable outcomes.

Comparative study of first-day postoperative cataract review methods.

PURPOSE: To assess whether telephone review on the first day after uneventful phacoemulsification is as effective as postoperative review in a hospital or the patients' home by nursing staff. SETTING: Sunderland Eye Infirmary, Sunderland, United Kingdom. METHOD: This prospective study comprised 3 arms, each of which consisted of 100 patients who had uneventful phacoemulsification with intraocular lens implantation. Patients received the same postoperative medications and were given a questionnaire regarding their opinions on the method of postoperative review. The method of review was different for each arm as follows: (1) home review by a nurse, (2) return to the hospital for review by a nurse, and (3) telephone review by a nurse. Statistical analysis of relative frequencies was done; exact testing was applied throughout to test for differences in proportions and, where applicable, to construct 95% confidence intervals. RESULTS: There were no significant differences between the 3 groups in the degree to which patients understood the instructions and questions. The telephone group was significantly less reassured than the home-visit group, but there was no significant difference in the degree of reassurance between the telephone and hospital-visit groups. Seventy percent of patients in the telephone group listed telephone review as their preferred method of postoperative review. CONCLUSION: In cases of uneventful phacoemulsification, telephone review is safe, effective, and acceptable and is a reasonable alternative to other first-day review methods.

The contribution to ophthalmic literature from different regions of the world.

PURPOSE: To compare the volume of ophthalmic literature from the developed and developing countries. METHODS: We performed a retrospective review of the five highest scoring impact factor journals in ophthalmology within the 3 year period 1998-2000 inclusive. Europe, North America, Australia, New Zealand and Japan were categorised as developed countries, all others were categorised as developing market economies. Correspondence, news articles and book reviews were excluded from our study. RESULTS: The developing world contributed to only 5.47% of the literature compared to the 92.19% from the developed world. The majority of the contribution to ophthalmic literature from the developing countries originated from Israel, S. America, China, Saudi Arabia, India, Singapore and Korea. 2.33% of literature was the result of collaborative research from the two groups. CONCLUSION: The developing countries account for 90.8% of world blindness, compared to 9.2% from the developed countries, there is therefore, an inverse relationship between the burden of world blindness and the contribution to the highest impact factor ophthalmic journals with the developed countries only contributing to 5% of this research.