Idiopathic vitreomacular traction and macular hole: a comprehensive review of pathophysiology, diagnosis, and treatment.
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ABSTRACT:
SUBMITTER: Steel DH
PROVIDER: S-EPMC3797995 | biostudies-other | 2013 Oct
REPOSITORIES: biostudies-other
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Project description:BackgroundIf left untreated, vitreomacular traction (VMT) will infrequently improve through spontaneous resolution of vitreomacular adhesion (VMA), and patients remain at risk of further deterioration in vision. The mainstay of treatment for VMT is vitrectomy, an invasive procedure that carries the risk of rare but serious complications and further vision loss. As such, a 'watch and wait' approach is often adopted before this surgical intervention is performed. Ocriplasmin (microplasmin) is a potential alternative treatment for patients with symptomatic VMT that may remove the requirement for vitrectomy.ObjectiveThe purpose of this study was to evaluate the cost-effectiveness of ocriplasmin for the treatment of VMT in comparison to standard of care.Study designA cohort-based computer simulation model was developed, capturing three mutually exclusive subgroups: 1) VMT without epiretinal membrane (ERM) or full thickness macular hole (FTMH), 2) VMT with ERM but no FTMH, and 3) VMT with FTMH. Transition probabilities between health states, utilities, and resource utilisation were estimated based on clinical trial results, the literature, and expert opinion. The cost per quality-adjusted life year (QALY) gained was estimated over a lifetime, using UK unit costs and utilities associated with visual acuity, adverse events, metamorphopsia, and surgical interventions.SettingAnalyses were conducted from a UK payer perspective.PopulationTransition probabilities for the model were primarily estimated from patient-level data from the combined Phase 3 MIVI-TRUST trials in patients with symptomatic VMA/VMT, including when associated with a FTMH ≤400 µm.InterventionOcriplasmin (microplasmin) is a one-time intravitreal injection designed specifically to release the abnormal traction between the macula and the vitreous and thereby treat VMT, as well as macular hole with persistent vitreous attachment.Main outcome measureThe main outcome measure of the economic evaluation was cost per QALY.ResultsIn all subgroups, ocriplasmin management generated more QALYs: 1) VMT without ERM or FTMH (0.105, (0.036, 0.191)); 2) VMT with ERM but no FTMH (0.041, (0.011, 0.131)); and 3) VMT with FTMH (0.053, (-0.002, 0.113)). The initial treatment costs were partially offset by later savings and net costs were estimated at £1,901 (£1,325, £2,474), £2,491 (£1,067, £2,511), and £1,912 (£1,233, £2,506), respectively. Costs per QALY were estimated at £18,056 (£8,241, £64,874), £61,059 (£8,269, £168,664), and £36,250 (-£144,788, £290,338), respectively. Short-term efficacy parameters were found to be key drivers of results.ConclusionOcriplasmin is most cost-effective in VMT patients without either ERM or FTMH.
| S-EPMC4920942 | biostudies-literature
Project description:PurposeTo assess the effect of an intravitreal ocriplasmin injection on visual function, measured using visual acuity (VA) and vision-related quality of life.MethodsPost hoc analysis of prespecified secondary end-points in two multicentre, randomized, double-masked, phase 3 clinical trials. A total of 652 participants with symptomatic vitreomacular adhesion were enrolled, of whom 464 received a single intravitreal injection of 125 μg ocriplasmin and 188 received a single intravitreal placebo injection. Based on principal components analysis results, visual function response (VFR) was defined as either a VA improvement of ≥2 lines; or an improvement in the composite score of the National Eye Institute Visual Function Questionnaire (VFQ-25) exceeding the minimal clinically important difference (MCID), estimated using the standard error of measurement approach; or an improvement in the VFQ-25 driving subscale score exceeding the MCID. The main outcome measure was VFR at 6 months.ResultsA VFR occurred in 55.1% of the ocriplasmin group versus 34.2% of the placebo injection group (p < 0.0001). This comprised 23.7% versus 11.2% (p = 0.0003) with a ≥ 2-line VA improvement, 35.9% versus 22.7% (p = 0.0016) for the VFQ-25 composite score, and 10.2% versus 6.2% (p = 0.1697) for the driving subscale.ConclusionOcriplasmin produces a clinically meaningful visual function benefit.
| S-EPMC5901404 | biostudies-literature
Project description:Vitreomacular traction (VMT) and VMT with macular hole (MH) are serious conditions, being associated with visual disturbance, for example, metamorphopsia, and diminished visual acuity (VA). Pars plana vitrectomy is the routine treatment for symptomatic VMT and VMT+MH. However, ocriplasmin has demonstrated favourable efficacy and safety in specific patient groups with VMT/MH and is now recommended as a treatment option for certain patients by the National Institute of Health and Care Excellence. This means that services for managing patients with VMT/MH may need to be revised, as patients can now potentially receive treatment earlier in the course of the disease. VMT triage clinics could provide a more efficient way of managing VMT/MH patients. Patient assessment should always include high-definition optical coherence tomography, as this is the most accurate means of assessing abnormalities in the vitreoretinal (VR) interface, and an accurate measurement of best-corrected VA. It has been proposed that patients with VMT+MH be managed as a routine 6-week referral, with the complete patient journey-from initial referral to treatment-taking no longer than 6 months. It is important that patients are entered onto VR surgical lists so that there is no delay if ocriplasmin treatment is unsuccessful. Patients will need appropriate counselling about the expected outcomes and possible side effects of ocriplasmin treatment. One-year follow-up data should be collected by treatment centres in order to evaluate the new VMT service.
| S-EPMC4097190 | biostudies-other
Project description:PurposeTo evaluate the real world clinical outcomes of intravitreal ocriplasmin in patients with vitreomacular traction (VMT) with and without full thickness macular holes (FTMH) treated according to NICE guidance.MethodsRetrospective observational case series of 25 patients treated with a single intravitreal ocriplasmin injection between December 2013 and December 2015. Best corrected visual acuity and optical coherence tomography exams were performed to determine visual outcomes and anatomical VMT release and FTMH closure over time. Two patient groups were identified: ocular macular co-morbidity (OCM) and no OCM (nOCM), with follow-up at 4, 12, and 24 weeks.ResultsTwenty-five patients were identified that included 19 patients with VMT, and 6 patients with VMT plus FTMH. In the nOCM group of 22 patients, the release rate of VMT was 44%, 63%, and 69% at 4, 12 and 24 weeks respectively. In the "real-world" OCM group of 25 patients, the VMT release rate was 37%, 53%, and 58% at the same time-points. In both groups, the FTMH closure rate was 33%, 50%, and 67% at 4, 12, and 24 weeks. At mean follow-up of 30 weeks in the VMT group with nOCM, the mean LogMAR VA improved significantly from 0.44 to 0.28 (p = 0.0068, paired t-test). Three were no serious adverse events.ConclusionsThis study reports improved efficacy of intravitreal ocriplasmin for both VMT and FTMH, and is more favourable in patients with no ocular co-morbidity. We highlight the importance of careful patient selection and structured standard of care pathways to identify patients who will benefit from the positive visual and anatomical effects of intravitreal ocriplasmin.
| S-EPMC5955569 | biostudies-literature
Project description:PURPORSE: To determine the associated balance of forces of the vitreofoveal interface in focal vitreomacular traction evolving to full-thickness macular hole (FTMH) and to link/explain the observed changes in the context of mathematical and physics models.This is a multicenter, prospective, and observational case series conducted at the Vitreoretinal Department of three different referral centers. Fellow eyes of patients with unilateral idiopathic FTMH were included. Eighty-nine patients were included in the analysis. The fellow normal eye of the study patients was imaged with spectral-domain optical coherence tomography. The main outcome measure was the optical-coherence-tomography-defined characteristics of the vitreofoveal interface and their analysis with mathematical and physics models at the end of follow-up period.Of the included 89 patients (66 women and 23 men; mean age±SD, 68.5 years±9.8), 10 (11.2%) developed FTMH at the fellow eye at the end of the follow-up period. We observed two types of vitreofoveal attachment. A V-shaped (cord-like) configuration and a U-shaped configuration. The eyes with the V-shaped attachment demonstrated initial structural changes in the outer foveal layers and the eyes with the U-shaped attachment showed inner morphological changes.We hypothesize that the type (V- or U-shaped) of the vitreofoveal attachment may affect the type and location of the initial structural change leading to the formation of FTMH from the stage of the focal vitreomacular traction.
| S-EPMC4268463 | biostudies-other
Project description:PurposeTo evaluate pneumatic vitreolysis (PVL) in eyes with vitreomacular traction (VMT) with and without full-thickness macular hole (FTMH).DesignTwo multicenter (28 sites) studies: a randomized clinical trial comparing PVL with observation (sham injection) for VMT without FTMH (Protocol AG) and a single-arm study assessing PVL for FTMH (Protocol AH).ParticipantsParticipants were adults with central VMT (vitreomacular adhesion was ≤3000 μm). In Protocol AG, visual acuity (VA) was 20/32 to 20/400. In Protocol AH, eyes had a FTMH (≤250 μm at the narrowest point) and VA of 20/25 to 20/400.MethodsPneumatic vitreolysis using perfluoropropane (C3F8) gas.Main outcome measuresCentral VMT release at 24 weeks (Protocol AG) and FTMH closure at 8 weeks (Protocol AH).ResultsFrom October 2018 through February 2020, 46 participants were enrolled in Protocol AG, and 35 were enrolled in Protocol AH. Higher than expected rates of retinal detachment and tear resulted in early termination of both protocols. Combining studies, 7 of 59 eyes (12% [95% CI, 6%-23%]; 2 eyes in Protocol AG, 5 eyes in Protocol AH) that received PVL developed rhegmatogenous retinal detachment (n = 6) or retinal tear (n = 1). At 24 weeks in Protocol AG, 18 of 23 eyes in the PVL group (78%) versus 2 of 22 eyes in the sham group (9%) achieved central VMT release without rescue vitrectomy (adjusted risk difference, 66% [95% CI, 44%-88%]; P< 0.001). The mean change in VA from baseline at 24 weeks was 6.7 letters in the PVL group and 6.1 letters in the sham group (adjusted difference, -0.8 [95% CI, -6.1 to 4.5]; P = 0.77). In Protocol AH, 10 of 35 eyes (29% [95% CI, 16%-45%]) achieved FTMH closure without rescue vitrectomy at 8 weeks. The mean change in VA from baseline at 8 weeks was -1.5 letters (95% CI, -10.3 to 7.3 letters).ConclusionsIn most eyes with VMT, PVL induced hyaloid release. In eyes with FTMH, PVL resulted in hole closure in approximately one third of eyes. These studies were terminated early because of safety concerns related to retinal detachments and retinal tears.
| S-EPMC8545749 | biostudies-literature
Project description:PurposeTo evaluate vitrectomy for diabetic macular edema (DME) in eyes with at least moderate vision loss and vitreomacular traction.DesignProspective cohort study.ParticipantsThe primary cohort included 87 eyes with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield >300 microns and no concomitant cataract extraction at the time of vitrectomy.MethodsSurgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.Main outcome measuresVisual acuity, OCT retinal thickening, and operative complications.ResultsAt baseline, median visual acuity in the 87 eyes was 20/100 and median OCT thickness was 491 microns. During vitrectomy, additional procedures included epiretinal membrane peeling in 61%, internal limiting membrane peeling in 54%, panretinal photocoagulation in 40%, and injection of corticosteroids at the close of the procedure in 64%. At 6 months, median OCT central subfield thickness decreased by 160 microns, with 43% having central subfield thickness <250 microns and 68% having at least a 50% reduction in thickening. Visual acuity improved by > or =10 letters in 38% (95% confidence interval, 28%-49%) and deteriorated by > or =10 letters in 22% (95% confidence interval, 13%-31%). Postoperative complications through 6 months included vitreous hemorrhage (5 eyes), elevated intraocular pressure requiring treatment (7 eyes), retinal detachment (3 eyes), and endophthalmitis (1 eye). Few changes in results were noted between 6 months and 1 year.ConclusionsAfter vitrectomy performed for DME and vitreomacular traction, retinal thickening was reduced in most eyes. Between 28% and 49% of eyes with characteristics similar to those included in this study are likely to have improvement of visual acuity, whereas between 13% and 31% are likely to have worsening. The operative complication rate is low and similar to what has been reported for this procedure. These data provide estimates of surgical outcomes and serve as a reference for future studies that might consider vitrectomy for DME in eyes with at least moderate vision loss and vitreomacular traction.
| S-EPMC2911350 | biostudies-literature
Project description:PurposeTo evaluate patient-reported visual function after ocriplasmin through the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25) in patients with symptomatic vitreomacular adhesion/vitreomacular traction including macular hole.MethodsThis was a prespecified analysis of a secondary endpoint from the OASIS trial. Patients received a single intravitreal injection of ocriplasmin (0.125 mg) or sham and completed the VFQ-25 questionnaire at baseline and at Months 6, 12, and 24. Clinically meaningful (≥5-point) changes from baseline were assessed.ResultsOf the 220 patients enrolled, 146 received ocriplasmin and 74 received sham. At Month 24, the percentage of patients with a ≥5-point improvement from baseline in VFQ-25 composite scores was higher with ocriplasmin versus sham (51.4% vs. 30.1%, 95% confidence interval, 8.1-34.5, P = 0.003). The percentage of patients with ≥5-point worsening at Month 24 was lower with ocriplasmin versus sham (9.5% vs. 15.6%, 95% confidence interval: -15.6 to 3.5, P = 0.191). A larger percentage of patients treated with ocriplasmin versus sham experienced a ≥5-point improvement in VFQ-25 composite and subscale scores at Month 24 regardless of baseline full-thickness macular hole status.ConclusionA larger percentage of patients with symptomatic vitreomacular adhesion/vitreomacular traction reported clinically meaningful improvements in self-assessed visual function with ocriplasmin than sham.
| S-EPMC7302331 | biostudies-literature
Project description:PurposeThis work reviews the literature regarding spontaneous closure of idiopathic full-thickness macular holes (FTMHs).MethodsLiterature on patients with spontaneous idiopathic FTMH closure was reviewed via Ovid MEDLINE, EMBASE, and PubMed through July 16, 2020. A total of 27 of 66 identified articles were included.ResultsA total of 68 eyes had spontaneous closure. Of the patients, 62.7% were women and the average age was 67.5 years. Visual acuity improved from Snellen 20/78 to 20/33 post closure. The average hole diameter was 176.8 μm; the largest was 350 μm. Most were stage 2 according to Gass and of small size according to International Vitreomacular Traction Study Group (IVTS) staging. The predominant classification system in recent literature is IVTS staging. The average optical coherence tomography-observed closure time was 4.5 months.ConclusionsOn review, reported spontaneous closure rates of all idiopathic FTMH range from 3% to 15%, and no demographic subgroups are more likely to have closure. Holes ≤250 µm have higher closure rates (22.2%) than those in the range of >250 to 400 µm (13.3%) and ≥400 µm (0%). Closure is associated with favorable visual outcomes, and retinal bridging via glial cells is likely critical to closure. These determinations were based on limited numbers; prospective studies are needed to further ascertain rate, mechanism, and characteristics. IVTS staging provides reliable reporting and insight into whether FTMH can be observed before surgery.
| S-EPMC9954929 | biostudies-literature
Project description:This study aimed to investigate the relationship between macular shape and idiopathic macular hole (MH) findings using an objective method. We present retrospective observational case series on patients with MH. The shape of the macular area was quantified using quadratic equations, and the ocular shape (OS) index was calculated. The correlation between the OS index and macular hole findings for each stage was evaluated. Pearson's correlation coefficient showed a significant correlation between the OS index and horizontal hole diameter (p = 0.044), bottom diameter (p = 0.006), and vertical bottom diameter (p = 0.024) in stage 2. For stage 4, there was a negative and significant correlation between the OS index and age (p = 0.037), and horizontal (p = 0.021) and vertical (p = 0.027) bottom diameter. Multiple regression analysis showed that the horizontal (p = 0.0070) and vertical (p = 0.031) bottom diameter and OS index were independently and positively correlated in stage 2. In stage 4, the OS index was independently and negatively correlated with the horizontal (p = 0.037) and vertical (p = 0.048) bottom diameter. The ocular shape of the macula affects MH findings, and its impact depends on its stage.
| S-EPMC10505151 | biostudies-literature