To test the hypothesis that tolerating some subretinal fluid (SRF) in patients with neovascular agerelated macular degeneration (nAMD) treated with ranibizumab using a treat-and-extend (T&E) regimen can achieve similar visual acuity (VA) outcomes as treatment aimed at resolving all SRF.Design: Multicenter, randomized, 24-month, phase 4, single-masked, noninferiority clinical trial.Participants: Participants with treatment-naïve active subfoveal choroidal neovascularization (CNV). Methods: Participants were randomized to receive ranibizumab 0.5 mg monthly until either complete resolution of SRF and intraretinal fluid (IRF; intensive arm: SRF intolerant) or resolution of all IRF only (relaxed arm: SRF tolerant except for SRF >200 mm at the foveal center) before extending treatment intervals. A 5-letter noninferiority margin was applied to the primary outcome.Main Outcome Measures: Mean change in best-corrected VA (BCVA), and central subfield thickness and number of injections from baseline to month 24.Results: Of the 349 participants randomized (intensive arm, n ¼ 174; relaxed arm, n ¼ 175), 279 (79.9%) completed the month 24. The mean change in BCVA from baseline to month 24 was 3.0 letters (standard deviation, 16.3 letters) in the intensive group and 2.6 letters (standard deviation, 16.3 letters) in the relaxed group, demonstrating noninferiority of the relaxed compared with the intensive treatment (P ¼ 0.99). Similar proportions of both groups achieved 20/40 or better VA (53.5% and 56.6%, respectively; P ¼ 0.92) and 20/200 or worse VA (8.7% and 8.1%, respectively; P ¼ 0.52). Participants in the relaxed group received fewer ranibizumab injections over 24 months (mean, 15.8 [standard deviation, 5.9]) than those in the intensive group (mean, 17 [standard deviation, 6.5]; P ¼ 0.001). Significantly more participants in the intensive group never extended beyond 4-week treatment intervals (13.5%) than in the relaxed group (2.8%; P ¼ 0.003), and significantly more participants in the relaxed group extended to and maintained 12-week treatment intervals (29.6%) than the intensive group (15.0%; P ¼ 0.005).Conclusions: Patients treated with a ranibizumab T&E protocol who tolerated some SRF achieved VA that is comparable, with fewer injections, with that achieved when treatment aimed to resolve all SRF completely.
IntroductionBreast cancer is the most common malignancy in women (Office of National Statistics 2002). As ophthalmic manifestations are common, the astute ophthalmologist can instigate the search for primary disease when the first presentation is ophthalmic in nature, or, alternatively, play an important role in detecting the metastatic spread of a known primary. Breast cancer accounts for 29% of new malignancies in women in the UK and is a major cause of mortality and morbidity worldwide.The purpose of this article is to provide a review of the ophthalmic manifestations of breast cancer. The subjects covered include the presenting features of metastatic disease involving the visual systems, treatment modalities and strategies currently available, and the ocular effects and complications of treatment. EpidemiologyIncidence rates of breast cancer have increased over the last decade, rising from 90 to 130 per 100 000 population (1988 versus 1998) (Office of National Statistics 2002). In contrast, mortality rates have remained relatively stable since the 1950s. This increase in the incidence of breast cancer is attributed to more effective screening programmes, although a change in the demographics of developed countries and an increasing elderly population may contribute to the growing incidence. Geographical variations exist in breast cancer incidence rates, with higher rates in Europe, North America and Oceania and lower rates in Asia and Africa (Sasco 2001). Doctors practising in the western world should be familiar with the disease.Male breast cancer is rare. The incidence is 0.8-1.5 cases per 100 000 male population, accounting for 1% of all breast cancer diagnoses (Office of National Statistics 2002; Hodgson et al. 2004). The highest incidence occurs in men aged over 70 years (Kidmas et al. 2005). In families with hereditary breast cancer, younger males may be affected. The BRCA2 gene is often implicated in these cases (Lorenzo Bermejo & Hemminki 2005).Ocular manifestations of male breast cancer can occur and this differential diagnosis should not be overlooked (O'Brien et al. 2000;Silvestris et al. 2003;Dieing et al. 2004). Ophthalmic metastases in breast cancerMetastatic disease to the eye from the breast was first described by Johann ABSTRACT.Context: Breast cancer is the most common malignancy in women, with increasing incidence in Europe and North America. The frequency of involvement of the eye and visual pathways is reported to be as high as 30% in patients with known metastatic disease. In some cases, ophthalmic involvement can be the first sign of metastatic spread. Metastasis occurs via the haematogenous route and predominantly involves the choroid. Metastases to other ocular structures, the orbit and the visual pathways have also been described. Paraneoplastic effects are rare but significant. Treatments: Different modalities are employed in the treatment of breast cancer and its metastases. These include chemotherapy and radiotherapy. The ocular adverse effects of these have been well described,...
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Aim The aim of this study was to record the subjective visual experience of patients during phacoemulsification and intraocular lens implantation under subtenons anaesthesia. Methods Prospective, nonrandomised, cohort, postoperative questionnaire based study. Patients selected underwent routine phacoemulsification and intraocular lens implantation under regional subtenons anaesthesia. v 2 and Fisher's exact tests (two-tail) were used to evaluate the data. Results A total of 104 patients were selected, 38 (36.5%) were male and 66 (63.5%) were female. The mean age of patients was 74.078.8 years. In all, 87.5% saw light during the operation with 9.6% finding this painful. Photophobia was highest among younger patients (P ¼ 0.002). Coloured lights were seen by 56.7% and 13.5% found the visual experience frightening. Frightening visual experiences were significantly associated with the perception of colour (P ¼ 0.005) and photophobia (P ¼ 0.003). A volume of anaesthetic greater than 4 m was associated with a significant reduction in anxiety as a result of the visual experience (P ¼ 0.003). None of the other visual phenomena recorded were associated with a frightening visual experience. Conclusions Patients undergoing regional anaesthesia experience a wide variety of visual sensations during cataract surgery. Perception of colour and volumes of anaesthetic less than 4 m appear to be associated with the visual experience being more frightening. Detailed preoperative counselling is mandatory. It should include comprehensive information about visual perception during the procedure relieving the patients from unnecessary distress.
Keratoconus is typically diagnosed through changes at the anterior ocular surface. However, we wished to assess if macular parameter changes might also occur in these patients. We assessed posterior changes through the use of optical coherence tomography and compared to a nonkeratoconus patient group. All subjects underwent clinical examination including macular thickness measurements. The generalized estimation equation model was used to estimate the means and compare the differences in various measurements between keratoconus and nonkeratoconus patients. A total of 129 keratoconus eyes of 67 cases and 174 nonkeratoconus eyes of 87 controls were analysed. Keratoconus individuals presented with a significantly greater mean retinal thickness in the central fovea, inner, and outer macula compared to the nonkeratoconus group (p < 0.05). In addition, individuals presenting with the early signs of keratoconus had significantly greater inner and outer macular volume compared to the nonkeratoconus group (p < 0.05). This study indicates the retina appears to thicken at the fovea and macula and had increased macular volume in keratoconus individuals compared to nonkeratoconus individuals. Thus we posit that structural retinal changes exist in keratoconus eyes that are additional to those typically seen in the anterior segment.
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