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Translational Vision Science &... Oct 2021To investigate the impact of supplementation with a targeted micronutrient formulation on the visual discomfort associated with vitreous degeneration. (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
To investigate the impact of supplementation with a targeted micronutrient formulation on the visual discomfort associated with vitreous degeneration.
METHODS
In this clinical trial, 61 patients with symptomatic vitreous floaters were randomized to consume daily, the active supplement consisting of 125 mg L-lysine, 40 mg vitamin C, 26.3 mg Vitis vinifera extract, 5 mg zinc, and 100 mg Citrus aurantium or placebo for 6 months. Change in visual discomfort from floaters, assessed with the Floater Disturbance Questionnaire, was the primary outcome measure. Secondary outcome measures included best-corrected visual acuity, letter contrast sensitivity, photopic functional contrast sensitivity with positive and negative contrast polarity, and quantitative vitreous opacity areas.
RESULTS
After supplementation, the active group reported a significant decrease in their visual discomfort from floaters (P < 0.001), whereas the placebo group had no significant change in their visual discomfort (P = 0.416). At 6 months, there was a significant decrease in vitreous opacity areas in the active group (P < 0.001) and an insignificant increase in vitreous opacity areas in the placebo group (P = 0.081). Also, there was a significant improvement in photopic functional contrast sensitivity with positive contrast polarity in the active group after supplementation (P = 0.047).
CONCLUSIONS
The findings of this study indicate improvements in vision-related quality of life and visual function of patients suffering from vitreous floaters after supplementation with a formulation of antioxidative and antiglycation micronutrients. Notably, these improvements were confirmed by the decrease in vitreous opacity areas in the active group.
TRANSLATIONAL RELEVANCE
This targeted dietary intervention should be considered to support patients with symptomatic vitreous degeneration.
Topics: Humans; Micronutrients; Quality of Life; Vision Disorders; Visual Acuity; Vitreous Body
PubMed: 34647961
DOI: 10.1167/tvst.10.12.19 -
Ophthalmic Surgery, Lasers & Imaging... Jun 2021To evaluate the safety and efficacy of 1.0 mg risuteganib in subjects with nonexudative age-related macular degeneration (AMD). (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND AND OBJECTIVE
To evaluate the safety and efficacy of 1.0 mg risuteganib in subjects with nonexudative age-related macular degeneration (AMD).
PATIENTS AND METHODS
This was a phase 2a, prospective, double-masked, sham-controlled study. Eyes with nonexudative (dry) AMD and Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) between 20/40 and 20/200 were included. Subjects were randomized to intravitreal 1.0 mg risuteganib or sham injection. At Week 16, subjects in the risuteganib group received a second 1.0-mg dose and the sham group crossed over to receive a dose of 1.0 mg risuteganib and were evaluated at Week 28. The primary endpoint was proportion of subjects with 8 letters ETDRS or more BCVA gain from baseline to Week 28 in the risuteganib group versus baseline to Week 12 for the sham group. BCVA was tested and subjects were observed for adverse events (AEs) every 4 weeks until completion of the study at 32 weeks.
RESULTS
Forty-five subjects (risuteganib, n = 29; sham, n = 16) were enrolled in the study, of whom 39 (risuteganib, n = 25; sham, n = 14) completed the study and were included in the per protocol efficacy analysis. At baseline, mean age was 78.8 and 75.9 years and mean BCVA was 67.1 and 64.4 letters in the sham and risuteganib groups, respectively. The primary endpoint was met by 48% of the risuteganib group at Week 28 and 7% of the sham group at Week 12 ( = .013). Of the risuteganib subjects, 20% gained 15 letters or more at Week 28, whereas no patients in the sham group at Week 12 achieved this visual acuity gain. The only ocular treatment-related treatment-emergent AE was vitreous floaters, which spontaneously recovered without sequelae. No drug-related serious AE was reported.
CONCLUSIONS
Risuteganib demonstrated significant BCVA improvement in patients with non-exudative AMD. No drug-related AEs were seen during a 32-week observation period. .
Topics: Angiogenesis Inhibitors; Diabetic Retinopathy; Double-Blind Method; Humans; Intravitreal Injections; Prospective Studies; Treatment Outcome; Visual Acuity
PubMed: 34185587
DOI: 10.3928/23258160-20210528-05 -
Scientific Reports Apr 2021To describe the eyes with vitreous floaters and to analyze the development of acute symptomatic posterior vitreous detachment (PVD). A retrospective review of medical...
To describe the eyes with vitreous floaters and to analyze the development of acute symptomatic posterior vitreous detachment (PVD). A retrospective review of medical records was performed on patients with the vitreous floater developed for the first time of their life. Peripapillary vitreous opacity (pVO) was searched in Ultra-wide field (UWF) scanning laser ophthalmoscopy and PVD stage was assessed through spectral-domain optical coherence tomography (SD-OCT). 196 patients (55 males and 141 females), who were 58.4 (± 9.1) years old, visited a retinal clinic 9.4 (± 9.1) days after they experienced vitreous floaters. In 196 eyes, pVO was noticed in 122 eyes (62.2%) at UWF. In 106 eyes where SD-OCT data were available, PVD was noticed in 100 eyes (94.3%). Symptomatic eyes showed more advanced stage of PVD (p < 0.001) than symptom free eyes. Eyes with floaters were more myopic (- 0.7 ± 2.2D vs - 0.5 ± 1.9D, p = 0.02), and had lower intraocular pressure (IOP) (14.7 ± 3.2 mmHg vs 15.2 ± 3.0 mmHg, p = 0.02) than the other symptom free eyes. In patients with first floater symptoms, PVD was in progress in most of the eyes not only the symptomatic eyes but also on the contralateral symptom free eyes. Eyes with vitreous floaters were more myopic and had lower IOP than the opposite symptom free eyes.
Topics: Acute Disease; Adult; Aged; Female; Humans; Lasers; Male; Middle Aged; Ophthalmoscopy; Retrospective Studies; Tomography, Optical Coherence; Vitreous Body; Vitreous Detachment
PubMed: 33903657
DOI: 10.1038/s41598-021-88371-9 -
Seminars in Ophthalmology Feb 2021To assess the quality, content, and readability of information available online on vitreous floater information.
OBJECTIVE
To assess the quality, content, and readability of information available online on vitreous floater information.
DESIGN
Cross-sectional study.
PARTICIPANTS
Not applicable.
METHODS
Websites were generated using a Google search of "vitreous floaters treatment" and "[State]" and were analyzed using a standardized checklist of 22 questions. Readability was assessed using the Flesch Reading Ease score. Websites met qualification criteria if they represented U.S.-based institutions, if they provided clinical care and addressed vitreous floater treatment on their website.
RESULTS
Of the 1,065 websites screened, 456 were included. Of these, 406 (89%) were private institutions, 24 (5.3%) were academic, and 26 (5.7%) were a combination of private and academic. The average readability score correlated to a 10th-12th grade reading level. Vitreous floater treatment was discussed on 283 (62.1%) websites and 63 (21.8%) websites discussed potential side effects. Google rank was inversely correlated with the depth of explanation (r = -0.114, = .016). Observation was the main treatment recommended (55.8%, n = 158), followed by laser treatment (27.6%, n = 78), no specific treatment recommendation (11.3%, n = 32), and vitrectomy (5.3%, n = 15). Centers with vitreoretinal surgeons were 16.43 times more likely to recommend vitrectomy than those without vitreoretinal surgeons ( < .001).
CONCLUSIONS
Online information about vitreous floater treatment is variable, and the material is at a higher than recommended reading level for health information. While treatment was discussed by nearly two thirds of websites, less than a quarter mentioned possible complications, and treatment recommendations varied significantly depending on physician training.
Topics: Comprehension; Consumer Health Information; Cross-Sectional Studies; Data Accuracy; Databases, Factual; Education, Distance; Eye Diseases; Humans; Internet; Patient Education as Topic; Search Engine; United States; Vitreoretinal Surgery; Vitreous Body
PubMed: 33599190
DOI: 10.1080/08820538.2021.1887898 -
Acta Ophthalmologica Sep 2021Effectiveness of ocriplasmin for vitreomacular traction (VMT) varies depending on the presence of common ocular conditions and patient selection criteria. We carried out... (Meta-Analysis)
Meta-Analysis
PURPOSE
Effectiveness of ocriplasmin for vitreomacular traction (VMT) varies depending on the presence of common ocular conditions and patient selection criteria. We carried out a systematic literature review and meta-analysis of ocriplasmin studies conducted in real-world settings (RWS) and compared outcomes with those from randomized controlled trials (RCTs).
METHODS
We included prospective and retrospective studies from RWS documenting effectiveness of ocriplasmin in patients with VMT with or without MH, and RCTs of ocriplasmin versus control. Key end-points were vitreomacular adhesion resolution (VMAR), nonsurgical MH closure, need for vitrectomy and safety. We conducted meta-regression on pooled results to evaluate effects of baseline covariates and study design on outcomes.
RESULTS
Thirty RWS (2402 patients) and 5 RCTs (737 patients) were included epiretinal membrane (ERM) and broad VMA were more prevalent in RCTs. Primary VMAR, vitrectomy and MH closure rates were comparable between RWS and RCTs. Rates of nsVMAR were significantly higher in RWS than RCTs (odds ratio 1.66; 95% confidence interval [CI]: 1.18-2.34). nsVMAR rates were inversely associated with ERM prevalence (odds ratio 0.20; 95% CI: 0.08-0.51). Compared with the recent OASIS trial, RWS reported a higher incidence of new/worsening subretinal fluid cases and less photophobia, photopsia, vitreous floaters, electroretinogram abnormalities and MH progression.
CONCLUSIONS
Ocriplasmin was significantly more effective in achieving nsVMAR in RWS than in RCTs. Lower ERM prevalence in RWS was the single significant explanatory variable for this difference. Conclusions on ocriplasmin safety in RWS are limited due to inconsistent reporting.
Topics: Fibrinolysin; Humans; Intravitreal Injections; Peptide Fragments; Randomized Controlled Trials as Topic; Retinal Diseases; Tomography, Optical Coherence; Visual Acuity
PubMed: 33369248
DOI: 10.1111/aos.14686 -
Journal of Vitreoretinal Diseases 2021This article evaluates our experience at a retina-only private practice with small-gauge pars plana vitrectomy (PPV) for visually significant vitreous floaters. We...
PURPOSE
This article evaluates our experience at a retina-only private practice with small-gauge pars plana vitrectomy (PPV) for visually significant vitreous floaters. We review the surgical outcomes, complication rates, and percentage of second-eye surgery for the same indication.
METHODS
A retrospective, interventional case series was conducted of consecutive patients undergoing PPV for significant vitreous floaters from September 2014 to December 2018 at a high-volume vitreoretinal surgery practice. Preoperative visual acuity (VA), complication rates, and visual outcome following surgery were evaluated.
RESULTS
A total of 104 eyes in 81 patients underwent PPV for visually significant floaters; 35 (43.2%) patients had PPV in both eyes. Mean preoperative VA was 0.16 ± 0.17 logMAR (∼20/29 Snellen equivalent) and improved to 0.12 ± 0.15 logMAR (∼20/26 Snellen; Wilcoxon test, = .008) at the last follow-up after PPV. All patients had improvement in VA at the final postoperative visit, with a VA of 20/40 or better achieved in 93.3% of cases. The complication rate of vitreous hemorrhage postoperatively was 0.96%. There were no cases of postoperative retinal tears, breaks, or endophthalmitis.
CONCLUSIONS
Small-gauge PPV in the carefully selected patient is an effective and safe procedure to eliminate symptoms. VA following PPV for vitreous floaters significantly improved. Nearly half of the patients studied (43.2%) underwent PPV in the other eye.
PubMed: 37006520
DOI: 10.1177/2474126420961736 -
Retina (Philadelphia, Pa.) Feb 2021Randomized clinical trials have demonstrated the safety and efficacy of ocriplasmin in patients with vitreomacular traction (VMT), including those with macular hole... (Observational Study)
Observational Study
PURPOSE
Randomized clinical trials have demonstrated the safety and efficacy of ocriplasmin in patients with vitreomacular traction (VMT), including those with macular hole (MH). The INJECT study prospectively evaluated ocriplasmin in the setting of clinical practice.
METHODS
INJECT was a Phase 4, multicenter, prospective observational study. Patients were followed up for 12 months. Assessments included nonsurgical VMT resolution, nonsurgical MH closure, best-corrected visual acuity, occurrence of vitrectomy, and adverse events.
RESULTS
The efficacy population (N = 395) received an ocriplasmin injection and had optical coherence tomography-confirmed VMT at baseline. At Day 28, the rate of nonsurgical VMT resolution was 40.7% in the overall group, and the rate of nonsurgical MH closure was 36.0% in the VMT with MH group. At Month 12, the rate of ≥2-line best-corrected visual acuity gain (irrespective of vitrectomy) was 36.8% in the overall group and 59.6% in the VMT with MH group. The percentage of patients who underwent vitrectomy in the study eye was 29.1% in the overall group and 55.6% in the VMT with MH group. Photopsia (9.8%) and vitreous floaters (6.8%) were the most frequent adverse events.
CONCLUSION
The INJECT study showed that ocriplasmin is effective in a clinical setting in patients with VMT, with or without MH. No new safety signals were identified from this large and surgeon-selected patient group, although the significant limitations of the study design without an image reading center and scheduled study visit timings should be noted.
Topics: Aged; Aged, 80 and over; Female; Fibrinolysin; Follow-Up Studies; Humans; Intravitreal Injections; Male; Middle Aged; Peptide Fragments; Prospective Studies; Retinal Perforations; Tomography, Optical Coherence; Treatment Outcome; Vitrectomy; Vitreous Body; Vitreous Detachment
PubMed: 32496343
DOI: 10.1097/IAE.0000000000002862 -
BMC Ophthalmology May 2020To review treatment outcomes from real-world data of patients with neovascular age-related macular degeneration (nAMD) treated with intravitreal aflibercept (IVT-AFL)... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
To review treatment outcomes from real-world data of patients with neovascular age-related macular degeneration (nAMD) treated with intravitreal aflibercept (IVT-AFL) injection.
METHODS
RAINBOW (ClinicalTrials.gov, NCT02279537) is an ongoing, observational, 4-year study to monitor the effectiveness and safety of IVT-AFL in patients with nAMD in clinical practice in France. Treatment-naïve patients diagnosed with nAMD who had been prescribed IVT-AFL by their treating physician were eligible. The regimens of interest were regular treatment interval cohort (patients who received three initial monthly IVT-AFL injections followed by regular injections every 2 months) and two irregular treatment interval cohorts (with and without three initial monthly injections). Here we describe results at 24 months in patients according to IVT-AFL treatment regimen.
RESULTS
The mean change in best-corrected visual acuity (BCVA) with IVT-AFL from baseline to 24 months was + 3.0 letters in the overall population (P < 0.05 vs baseline). The mean change was positive for the regular and irregular treatment interval cohorts with initial doses (+ 4.9 and + 4.0 letters, respectively; P < 0.05 vs baseline) and negative for the irregular treatment interval cohort without initial doses (- 2.5 letters; P = 0.365 vs baseline) at 24 months. The mean overall number of IVT-AFL injections over 12 and 24 months was 6.0 and 8.8, respectively. The most common ocular adverse events were lack of efficacy (6.3%), vitreous floaters (2.7%), and increased lacrimation (1.7%).
CONCLUSIONS
In the real-world RAINBOW study, visual outcomes observed at 24 months were consistent with results from the primary endpoint at 12 months. In this study, treatment-naïve patients who received three initial IVT-AFL doses and regular IVT-AFL treatment over the first 24 months experienced better visual outcomes than patients who received no initial doses and an irregular treatment regimen.
TRIAL REGISTRATION
www.ClinicalTrials.gov (NCT02279537). Registered 29 October 2014.
Topics: Aged; Aged, 80 and over; Angiogenesis Inhibitors; Choroidal Neovascularization; Female; Follow-Up Studies; Humans; Intravitreal Injections; Male; Receptors, Vascular Endothelial Growth Factor; Recombinant Fusion Proteins; Tomography, Optical Coherence; Treatment Outcome; Vascular Endothelial Growth Factor A; Visual Acuity; Wet Macular Degeneration
PubMed: 32450838
DOI: 10.1186/s12886-020-01468-z -
Eye (London, England) May 2020To evaluate the efficacy and safety of pars plana vitrectomy for symptomatic floaters.
BACKGROUND/OBJECTIVES
To evaluate the efficacy and safety of pars plana vitrectomy for symptomatic floaters.
SUBJECTS/METHODS
Forty-eight vitreoretinal surgeons from 16 countries provided information on 581 eyes who underwent vitrectomy for floaters in this retrospective survey study conducted by European VitreoRetinal Society. Percentage symptomatic improvement, incidence of retinal tears/detachment and post-vitrectomy cataract surgery, and the factors associated with satisfaction and complications were investigated.
RESULTS
Ninety-two percent were satisfied with the results, with 86.3% reporting complete resolution of daily-life symptoms. Overall satisfaction was lower in patients with smaller vitreous opacities at presentation (OR:0.4). Iatrogenic retinal breaks occurred in 29 eyes (5%). Core vitrectomy and cut rates of 1500-4000 or >4000 cuts/min were associated with lower risk of retinal breaks than complete vitrectomy (OR:0.05) and cut rates < 1500 cuts/min (OR: 0.03, 0.12, respectively). Fourteen eyes (2.4%) developed retinal detachment at a median of 3 months; and 84 (48.6%) developed cataract at a median of 16 months post-vitrectomy.
CONCLUSIONS
Pars plana vitrectomy resulted in high patient satisfaction with relatively low rate of severe complications in a large group of patients. The procedure may be safer when core vitrectomy and cut rates > 1500 cuts/min are favoured. Proper patient selection and informed consent are the most important aspects of surgery.
Topics: Humans; Postoperative Complications; Retinal Detachment; Retinal Perforations; Retrospective Studies; Vitrectomy; Vitreous Body
PubMed: 32313173
DOI: 10.1038/s41433-020-0825-0 -
International Journal of Ophthalmology 2020To investigate the depressive state among the patients with symptomatic vitreous floaters (SVF), as well as its change after SVF removal vitrectomy surgery.
AIM
To investigate the depressive state among the patients with symptomatic vitreous floaters (SVF), as well as its change after SVF removal vitrectomy surgery.
METHODS
Twenty-eight eyes of 28 patients who underwent 27-gauge pars plana vitrectomy (PPV) for SVF were included. Thirty-nine eyes of 39 age- and gender-matched healthy volunteers without SVF were also recruited as a healthy control. Center for Epidemiologic Studies Depression (CES-D) was used to assess volunteers and patients' depression (before and 1wk after PPV).
RESULTS
The CES-D score was 18.3±8.6 for patients, and was 12.4±6.0 for healthy control (=0.003). Patients were significantly more likely to be in a depressive state (53.6%, defined as CES-D score ≥16) than the healthy control (20.5%, =0.005). For patients with SVF, the CES-D score was negatively correlated with their age ( =-0.42, =0.025). After PPV, both the CES-D score (11.9±5.4 18.3±8.6, <0.001) and proportion of depressive state (18.5% 53.6%, =0.005) were significantly decreased.
CONCLUSION
This study suggests that symptoms of vitreous floaters have an apparently negative impact on patients' psychological state. The PPV can effectively relieve the depressive state for patients with SVF.
PubMed: 32309177
DOI: 10.18240/ijo.2020.03.07