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.
ARMD has a major impact on our sample values TTO health state values. Differences across four visual health severity groups appear larger than those found for a generic preference-based measure and patient TTO values. For conditions that are difficult to describe and imagine, simulation methods may offer an additional tool when combined with usual methods of description for obtaining better informed general population preferences.
Patients with retinal detachment often present to their general practitioner, emergency department, or optometrist after central vision has been compromised. This delay is unfortunate because early repair results in little or no visual loss. Once the detachment extends across the fovea (the central macula), permanent visual impairment is almost inevitable. Thorough examination of the retina needs equipment that is rarely available to non-ophthalmologists. Recognition of symptoms and awareness of the risk factors for retinal detachment may help in making speedy referrals and saving vision.
Our experience and the results of the meta-analysis suggest that macular hole surgery should be offered as early as possible once full-thickness neuroretinal defect occurs.
Aims: To identify the contributory factors associated with different sites of occlusion and the presence or absence of optic nerve head swelling (ONHS). Methods: 874 cases of retinal venous occlusion (RVO) were prospectively examined at a tertiary referral centre and classified according to three defined sites of occlusion: arteriovenous crossing RVO (AV-RVO); optic cup RVO (OC-RVO); and optic nerve sited RVO. Optic nerve sited RVOs were further divided on the basis of presence (ONHS-RVO) and absence (NONHS-RVO) of ONHS. RVOs not occurring at any of the defined sites were grouped as no-site RVO (NS-RVO). Important clinical parameters were compared among four of the five subgroups by multivariate analysis of variance and χ 2 test (NS-RVO excluded).
Results:The overall multivariate analysis of variance for differences in the mean age, systolic and diastolic blood pressure, body mass index, and intraocular pressure (IOP) among the four subgroups were highly significant (p <0.0001). The F ratios indicated that the differences in the mean age and IOP accounted for this statistical trend. The mean age was statistically significantly lower in the ONHS-RVO group compared to the rest of the groups (p <0.0001). The mean age was significantly higher in OC-RVO compared to the AV-RVO group (p <0.05). The mean IOP was significantly higher in OC-RVO than in the rest of the groups (p <0.01 to 0.0001), while it was also higher in the NONHS-RVO group compared to the ONHS-RVO and AV-RVO groups (p <0.0001). The prevalence of primary open angle glaucoma (POAG), sex, laterality, involvement of the fellow eye, smoking and hypertension were compared by χ 2 tests. POAG was significantly more prevalent in the OC-RVO group than in the rest of the groups (p <0.0083), while it was also significantly more prevalent in the NONHS-RVO group compared to AV-RVO or ONHS-RVO (p <0.0083) groups. Smoking was significantly more prevalent in AV-RVO than in the rest of the groups (p <0.05). The proportion of male sex was significantly higher in ONHS-RVO compared to the AV-RVO group (p <0.05). Hypertension was significantly more prevalent in the AV-RVO than in the ONHS-RVO or NONHS-RVO groups (p <0.05). Conclusion: A new classification of RVO based on the site of occlusion and ONHS has been evaluated. The higher prevalence of hypertension and smoking in AV-RVO suggests a particular importance of cardiovascular risk factors in this group. The association of POAG with CRVO has been confirmed, but only for those cases without ONHS. A distinctive relation between raised IOP and OC-RVO has been demonstrated, suggesting a causal association. RVOs with ONHS tend to occur in younger people, with a higher proportion of males, and a lower prevalence of hypertension and POAG, suggesting that other causal factors may be important in this group. The new scheme resolves the confusion in the literature regarding classification of RVO, and has diagnostic, causal, prognostic, and therapeutic implications.
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