Visual function response to ocriplasmin for the treatment of vitreomacular traction and macular hole

Jackson, Timothy L.; Verstraeten, Thomas; Duchateau, Luc; Lescrauwaet, Bénédicte

doi:10.1111/aos.13369

Cited by 11 publications

(11 citation statements)

References 33 publications

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“…Macular hole (MH) surgery currently consists of pars plana vitrectomy (PPV), internal limiting membrane (ILM) peeling and gas tamponade (Kelly & Wendel 1991;Wendel et al 1993;Ko et al 2017;Hamoudi et al 2018). It has also been shown that MHs can be successfully treated with intravitreal ocriplasmin in cases of MHs associated with vitreomacular adhesion and vitreomacular traction (Jackson et al 2017). The success rate of MH closure with these procedures has improved to at least 90%.…”

Section: Introductionmentioning

confidence: 99%

Best surgical technique and outcomes for large macular holes: retrospective multicentre study in Japan

Yamashita

Sakamoto

Terasaki

et al. 2018

Acta Ophthalmologica

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The purpose of this study was to compare the surgical outcomes of vitrectomy with conventional internal limiting membrane (C-ILM) peeling to that with the inverted ILM (I-ILM) flap technique for large macular holes (MHs). This was a retrospective chart review of consecutive cases with a large MH at nine hospitals in Japan. Among the 1342 eyes, 165 eyes of 165 cases met the inclusion criteria. The results for medium-large MHs with a diameter 400-550 μm were compared to that of eyes with an extra-large MH with a diameter >550 μm. In addition, the results of C-ILM peeling were compared to that of the I-ILM technique. In medium-large MHs, the closure rate was 95.2% (59/62) by C-ILM peeling and 100% (19/19) by the I-ILM technique. In extra-large MHs, the closure rate was 88.4% (38/43) by C-ILM peeling and 100% (41/41) by I-ILM. Although the difference between the two methods was not significant, the I-ILM technique was successful in 100% of the cases. Multiple logistic regression analysis showed the best-corrected visual acuity (BCVA) at 6 months was significantly associated with the preoperative BCVA, MH size, age and sex of the patient. Analyses of the eyes with extra-large MHs show that the surgical success is high, and the I-ILM technique is more effective for closure in eyes with extra-large MHs.

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Section: Introductionmentioning

confidence: 99%

Best surgical technique and outcomes for large macular holes: retrospective multicentre study in Japan

Yamashita

Sakamoto

Terasaki

et al. 2018

Acta Ophthalmologica

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“…In addition, all results were reported irrespective of vitrectomy, meaning if a patient’s eye disease deteriorated and required a vitrectomy this was not considered as a treatment failure (or nonresponse). The two reports by Jackson et al26 and Lescrauwaet et al30 also reported secondary outcomes from the same RCTs, however, a patient-centered composite endpoint consisting of visual acuity, VFQ-25 and need for vitrectomy was reported. In these responder analyses, a patient was considered a visual function responder when a clinically meaningful improvement in any of these principal traits of visual functioning was achieved, without the need for a vitrectomy.…”

Section: Resultsmentioning

confidence: 99%

“…Figure 1 presents the study flow diagram with numbers of records screened, assessed for eligibility and included in the review. A total of six publications were included in this review: two reports of three RCTs: Stalmans et al,11 Dugel et al;12 and four reports that analyzed PRO outcomes from the same RCT: Gandorfer et al,23 Varma et al,29 Jackson et al,26 Lescrauwaet et al30…”

Section: Resultsmentioning

confidence: 99%

“…From the ocriplasmin clinical studies, a composite functional endpoint called visual function response (VFR) was developed 26. This endpoint was composed of three scores (clinical proxies) namely the VFQ-25 composite score (CS), VFQ-25 driving subscale and best corrected visual acuity (BCVA) in the case of the MIVI-TRUST analysis vs VFQ-CS, VFQ-mental health score (MHS) and BCVA in the case of the OASIS analysis.…”

Section: Results Of Individual Studiesmentioning

confidence: 99%

“…Improvement in the VFQ-25 is evaluated using 12 subscale scores and a global composite score with higher scores indicating better health status 24,25. More recently, another composite PRO was developed using principal component analysis (PCA), to comprehensively evaluate changes in vision-related functioning as experienced by patients 26. A PCA reduces a multidimensional response into a restricted set of responses, called principal components, in an objective way while preserving as much of the overall variability in the multidimensional response as possible 27.…”

Section: Methodsmentioning

confidence: 99%

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<p>Patient-reported outcomes of ocriplasmin for the treatment of vitreomacular traction: a systematic review and synthesis of the literature</p>

Lescrauwaet¹,

Blot²,

Jackson³

2019

PROM

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Purpose Vitreomacular traction (VMT) is a disease in which the vitreous exerts abnormally strong traction on the macula, the area of the eye responsible for detailed central vision. If this traction significantly distorts the macula then VMT can lead to troublesome distorted vision (metamorphopsia), sometimes occurring despite relatively preserved visual acuity. Ocriplasmin, administered as a single intravitreal injection, aims to release VMT and improve vision. While the effect of ocriplasmin on traction release and visual acuity is well characterized, the effect of symptoms like metamorphopsia is not. Methods A systematic review and synthesis of the literature on patient reported outcomes (PRO) in relation to the use of ocriplasmin for the treatment of VMT was undertaken using MED-LINE and Embase databases, and the Cochrane central register of controlled trials (CENTRAL). Results The review identified PRO data from 870 patients across three randomized controlled trials. The most commonly reported PROs were the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25), a broad measure of vision-related quality of life, and Visual Function Response (VFR), an outcome combining quality of life and visual acuity outcomes. Treatment with ocriplasmin produced significant patient benefit vs control (sham or placebo-injection). Ocriplasmin was associated with a higher proportion of patients experiencing a clinically meaningful improvement in visual functioning with a difference of 11.8% for VFQ-25 and 23.2% for VFR responder analyses, respectively. Conclusion Patients with VMT have material impairment in visual functioning and quality of life, relative to their reduction in visual acuity. Ocriplasmin results in a significant improvement in visual functioning. Future research could include the development of new PROs specific to VMT.

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Nd:YAG laser vitreolysis versus pars plana vitrectomy for vitreous floaters

Kokavec

Sherwin

et al. 2017

Cochrane Database of Systematic Reviews

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There are currently no RCTs that compare Nd:YAG laser vitreolysis with pars plana vitrectomy for the treatment of symptomatic floaters. Properly designed RCTs are needed to evaluate the treatment outcomes from the interventions described. We recommend future studies randomise participants to either a Nd:YAG laser vitreolysis group or a vitrectomy group, with participants in each group assigned to either receive treatment or a sham intervention. Future studies should follow participants at six months and 12 months after the intervention. Also they should use best corrected visual acuity (BCVA) using an Early Treatment of Diabetic Retinopathy Study (ETDRS) chart read at 4 metres, vision-related quality of life (VRQOL), and adverse outcomes as the outcome measures of the trial.

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Visual function response to ocriplasmin for the treatment of vitreomacular traction and macular hole

Cited by 11 publications

References 33 publications

Best surgical technique and outcomes for large macular holes: retrospective multicentre study in Japan

Best surgical technique and outcomes for large macular holes: retrospective multicentre study in Japan

<p>Patient-reported outcomes of ocriplasmin for the treatment of vitreomacular traction: a systematic review and synthesis of the literature</p>

Nd:YAG laser vitreolysis versus pars plana vitrectomy for vitreous floaters

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