Ophthalmology最新文献

Purpose: To investigate the natural course of vitreous hemorrhage (VH) due to posterior vitreous detachment (PVD).

Design: Retrospective chart review.

Participants: Consecutive patients with VH due to presumed PVD between January 1, 2017, and December 31, 2021. Patients were followed conservatively.

Methods: Patients with a first episode of VH at a large eye hospital were included retrospectively through review of medical charts. Patients with a history of proliferative diabetic retinopathy, retinal venous occlusion, or wet age-related macular degeneration were excluded.

Main outcome measures: Patients were followed for a minimum of 2 years until one of the following outcomes occurred: spontaneous VH clearing, rhegmatogenous retinal detachment (RRD), vitrectomy for persistent VH, or referral to a medical retinal service.

Results: We included 366 patients (366 eyes); mean age was 65.2 years (standard deviation, 10.8), and 42.9% were women. Vitreous hemorrhage obscured the fundus in 295 eyes (80.6%). Vitreous hemorrhage cleared spontaneously in 227 eyes (62%), whereas RRD occurred in 61 eyes (17%). Rhegmatogenous retinal detachment plateaued at 20 days, indicating a time-dependent pattern. The risk of retinal detachment was significantly higher in men (hazard ratio [HR], 2.90 [1.64-5.12], P < 0.001) compared with women. Older patients exhibited a lower risk of RRD (HR, 0.27; 95% confidence interval [CI], 0.13-0.59, P < 0.001 in the 65- to 73-year age group and HR, 0.25; 95% CI, 0.10-0.63, P = 0.003 in the 73- to 94-year age group). Spontaneous clearing was associated with the density of VH. After 60 days, only 48% of the eyes cleared spontaneously. Thirty-six eyes did not clear, requiring vitrectomy after a median duration of 98 days (62.75-140.75).

Conclusions: This study demonstrates that VH presumed secondary to PVD showed great variability but generally took several months to clear, with 62% resolving spontaneously. However, 17% developed RRD, the majority during the first 3 weeks. Male gender and young age increased RRD risk. These findings highlight the importance of vigilant monitoring during the early phase and indicate that individual patient characteristics may guide management strategy. Further prospective studies are warranted to refine risk stratification and optimize management protocols in this patient population.

Financial disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Purpose: The NEW DAY (NCT04469595) study assessed the efficacy and safety of the fluocinolone acetonide (FAc; 0.19 mg) intravitreal implant as baseline therapy in diabetic macular edema (DME).

Design: Prospective, randomized, single-masked, active-controlled, multicenter, 18-month, phase 4 study.

Participants: Adults with type 1 or 2 diabetes and center-involving DME confirmed by central subfield thickness (CST).

Intervention: Treatment regimens were FAc implant followed by rescue supplemental injections of aflibercept if needed (2 mg/0.05 mL) for 17 months versus aflibercept loading dose (2 mg every 4 weeks, for 5 consecutive doses) followed by rescue supplemental injections of aflibercept if needed (2 mg/0.05 mL) for 13 months.

Main outcome: The primary endpoint was mean rescue supplemental injections of aflibercept needed during the study by treatment group. Additional outcomes included time to first rescue supplemental injection, best-corrected visual acuity (BCVA), CST, rates of cataract procedures, and increases in intraocular pressure (IOP).

Results: 517 participants were screened, 306 randomized. Mean (SD) rescue supplemental injections were 2.4 (3.2) with FAc and 2.5 (3.1) with aflibercept (P=0.76; primary endpoint). Counting both protocol-mandated and rescue supplemental injections, the FAc group received fewer injections compared with the aflibercept group (3.4 [3.2] vs. 7.2 [3.4] injections; nominal P<0.001). Time to first rescue supplemental injection was longer with FAc than aflibercept (mean [SD] 185.4 [97.9] vs. 132.8 [94.0] days; nominal P<0.001). Proportions of participants who did not receive rescue supplemental injections were similar (32.5% vs. 30.3%; nominal P=0.68). Mean change in BCVA was similar between groups (1.8 vs. 5.5 letters; nominal P=0.08) as was the change in CST (mean [SD] -119 [112] vs. -114 [103] μm; nominal P=0.71). In the FAc group, 27.9% received a cataract procedure versus 6.6% in the aflibercept group. Increased IOP occurred in 15.6% and 3.3% of participants in the FAc and aflibercept groups, respectively.

Conclusions: Although the primary endpoint of rescue supplemental injection superiority was not met, FAc-treated participants achieved similar visual and anatomic improvements as those receiving aflibercept with fewer than half the number of total injections throughout the study. Safety data results were consistent with previous FAc implant studies.