-
Survey of Ophthalmology 2023Seeking treatment for bothersome vitreous floaters is patient driven. To measure the impact of floaters and treatment on an individual's quality of life,... (Review)
Review
Seeking treatment for bothersome vitreous floaters is patient driven. To measure the impact of floaters and treatment on an individual's quality of life, patient-reported outcome measurements (PROMs) are essential. We review all studies using a PROM for patients with floaters. We evaluated content coverage against quality-of-life domains previously identified in other ophthalmic disorders, and against a qualitative study investigating quality-of-life issues in patients with floaters. We assessed measurement properties of PROMs using an extensive range of psychometric quality criteria. We identified 59 studies using 28 different PROMs. Many PROMs were not specifically developed for patients with floaters. Floater-specific PROMs were mostly based on content validation from an ophthalmologist or researcher perspective; two included a patient perspective. Using the outcomes of the qualitative study, we found that the floater-specific PROMs were narrow in their content coverage, with most items relating to visual symptoms and activity limitations. Testing the psychometric quality of PROMs was rare, and when employed mostly limited to responsiveness and known group validity. The remarkable high number of floater-specific PROMs reveals a need for such measurements in ophthalmology. Unfortunately, reporting on psychometric quality is limited, and content development is most often done without patient involvement.
PubMed: 37315741
DOI: 10.1016/j.survophthal.2023.06.003 -
Ophthalmology and Therapy Dec 2022This study aimed to determine the efficacy and safety of pars plana vitrectomy (PPV) as treatment for patients with primary symptomatic vitreous floaters.
INTRODUCTION
This study aimed to determine the efficacy and safety of pars plana vitrectomy (PPV) as treatment for patients with primary symptomatic vitreous floaters.
METHODS
We searched 12 databases for studies performing PPV for primary symptomatic vitreous floaters with at least 3 months follow-up. Two authors reviewed the studies and extracted data. Our main outcome of interest was patient satisfaction/reduction of symptoms/quality of life, but other measures of efficacy and safety were also extracted. Where possible, meta-analyses were performed to provide summary estimates.
RESULTS
We identified 18 eligible studies, which included 2077 eyes of 1789 patients. Studies reported that at least 90% of the patients were satisfied or had relief of symptoms. Best corrected visual acuity improved - 0.08 logMAR (95% CI - 0.10 to - 0.06 logMAR, P < 0.0001). Contrast sensitivity improved - 2.26% (95% CI - 3.26 to - 1.26%, P < 0.0001). After surgery, cataract occurred in 31.7% (95% CI 21.7-42.7%), retinal tears/breaks in 2.92% (95% CI 1.38-4.97%), vitreous hemorrhage in 1.97% (95% CI 0.83-3.54%), macular edema in 1.70% (95% CI 0.84-2.83%), retinal detachment in 1.54% (95% CI 0.62-2.82%), glaucoma in 1.04% (95% CI 0.53-1.73%), and endophthalmitis in 0.18% (95% CI 0.02-0.45%).
CONCLUSIONS
Postoperative patient satisfaction is high after PPV for primary symptomatic vitreous floaters. However, the patient should be carefully counselled as what to expect from the treatment and understand the risks associated with PPV.
PubMed: 36198880
DOI: 10.1007/s40123-022-00578-9 -
The Cochrane Database of Systematic... Jun 2017The vitreous is the clear jelly of the eye and contains fine strands of proteins. Throughout life the composition of this vitreous changes, which causes the protein... (Review)
Review
BACKGROUND
The vitreous is the clear jelly of the eye and contains fine strands of proteins. Throughout life the composition of this vitreous changes, which causes the protein strands in it to bundle together and scatter light before it reaches the retina. Individuals perceive the shadows cast by these protein bundles as 'floaters'. Some people are so bothered by floaters that treatment is required to control their symptoms. Two major interventions for floaters include Nd:YAG laser vitreolysis and vitrectomy. Nd:YAG laser vitreolysis involves using laser energy to fragment the vitreous opacities via a non-invasive approach. Vitrectomy involves the surgical replacement of the patient's vitreous (including the symptomatic vitreous floaters) with an inert and translucent balanced salt solution, through small openings in the pars plana.
OBJECTIVES
To compare the effectiveness and safety of Nd:YAG laser vitreolysis to pars plana vitrectomy for symptomatic vitreous floaters.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 12), MEDLINE Ovid (1946 to 17 January 2017), Embase Ovid (1947 to 17 January 2017), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to 17 January 2017), the ISRCTN registry (www.isrctn.com/editAdvancedSearch); searched 17 January 2017, ClinicalTrials.gov (www.clinicaltrials.gov); searched 17 January 2017 and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en); searched 17 January 2017. We did not use any date or language restrictions in the electronic searches for trials. We also searched conference proceedings to identify additional studies.
SELECTION CRITERIA
We included only randomised controlled trials (RCTs) that compared Nd:YAG laser vitreolysis to pars plana vitrectomy for treatment of symptomatic floaters.
DATA COLLECTION AND ANALYSIS
We planned to use methods recommended by Cochrane. The primary outcome we planned to measure was change in vision-related quality of life from baseline to 12 months, as determined by a vision-related quality of life questionnaire. The secondary outcomes we planned to measure were best corrected logMAR or Snellen visual acuity at 12 months for the treated eye(s) and costs. Adverse outcomes we planned to record were the occurrence of sight-threatening complications by 12 months (asymptomatic retinal tears, symptomatic retinal tears, retinal detachment, cataract formation, and endophthalmitis).
MAIN RESULTS
No studies met the inclusion criteria of this review.
AUTHORS' CONCLUSIONS
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.
Topics: Eye Diseases; Humans; Lasers, Solid-State; Vitrectomy
PubMed: 28570745
DOI: 10.1002/14651858.CD011676.pub2 -
Graefe's Archive For Clinical and... Jul 2016We aimed to provide a meta-analysis of the factors affecting vitreomacular traction (VMT) resolution after ocriplasmin use. A comprehensive systematic review of the... (Meta-Analysis)
Meta-Analysis Review
Ocriplasmin use for vitreomacular traction and macular hole: A meta-analysis and comprehensive review on predictive factors for vitreous release and potential complications.
PURPOSE
We aimed to provide a meta-analysis of the factors affecting vitreomacular traction (VMT) resolution after ocriplasmin use. A comprehensive systematic review of the complications after ocriplasmin use for VMT and macular hole was also done.
METHODS
A literature search in PubMed was performed for studies about ocriplasmin published before 30 June 2015. Then a meta-analysis of the factors affecting the VMT resolution after ocriplasmin use was done, providing the pooled odds ratios for each factor and 95 % confidence intervals (CIs). We also described the potential adverse events after ocriplasmin use in a systematic review.
RESULTS
A total of 194 abstracts were screened and 19 eligible studies were included in the meta-analysis. Age <65 years, female gender, vitreomacular adhesion diameter <1500 μm, phakic lens status and epiretinal membrane absence were found as positive predictive factors for VMT resolution, while macular hole size <250 μm was significantly associated with macular hole closure at the meta-analytical level. Various complications after ocriplasmin use were reported by frequency, including mainly vitreous floaters, photopsias, visual acuity decrease, ellipsoid zone changes, subretinal fluid development, enlargement of macular hole, anterior segment changes and electroretinogram alterations. It has to be noted that significant methodological weaknesses were identified, such as the absence of control groups or lack of transparency in the recruitment process and the examination procedure.
CONCLUSIONS
It is important to carefully select patients for ocriplasmin injection, taking into account the various predictive factors for VMT resolution. Patients should be informed about the potential adverse events of ocriplasmin, although they mainly seemed to be transient and usually mild/moderate in severity, suggesting that ocriplasmin is a safe and effective new treatment alternative for VMT and macular hole. However, due to the limited study quality, the uncertainty concerning the efficacy of this new approach is increased.
Topics: Fibrinolysin; Humans; Intravitreal Injections; Peptide Fragments; Retinal Perforations; Treatment Outcome; Vitreous Detachment
PubMed: 27137631
DOI: 10.1007/s00417-016-3363-5 -
Survey of Ophthalmology 2022Ocriplasmin is used to treat vitreomacular traction (VMT), with or without full-thickness macular hole (MH). We systematically reviewed the evidence on ocriplasmin's... (Meta-Analysis)
Meta-Analysis Review
Ocriplasmin for treatment of vitreomacular traction and macular hole: A systematic literature review and individual participant data meta-analysis of randomized, controlled, double-masked trials.
Ocriplasmin is used to treat vitreomacular traction (VMT), with or without full-thickness macular hole (MH). We systematically reviewed the evidence on ocriplasmin's effect on vitreomacular adhesion resolution (VMAR), MH closure, vitrectomy, and best-corrected visual acuity (BCVA) and investigated the effect of baseline covariates on outcome. We applied individual participant data meta-analyses to the entire population and to subgroups defined by MH or epiretinal membrane (ERM) presence. Safety data were pooled and tabulated. Five randomized controlled trials (1,067 participants) were included. Six months after treatment, ocriplasmin achieved higher rates of VMAR and MH closure versus control, lowered vitrectomy odds, and increased the likelihood of a ≥10-letter BCVA increase. VMAR rates were lower when ERM, broad VMA (> 1500 µm), diabetic retinopathy, or pseudophakia were present and higher in younger participants, women, and eyes with MHs. Ocriplasmin-treated participants experienced more short-term visual impairment that was not predictive of final BCVA, as well as vitreous floaters, photopsia, photophobia, eye pain, blurred vision, and dyschromatopsia. The most common serious adverse events for ocriplasmin and control, respectively, were MH progression (22.5%, 17.3%), new MH (1.5%, 3.4%) and retinal detachment (0.8%, 1.2%). Ocriplasmin promotes VMAR and MH closure. Transient visual phenomena are not uncommon.
Topics: Female; Fibrinolysin; Humans; Intravitreal Injections; Peptide Fragments; Retinal Diseases; Retinal Perforations; Tomography, Optical Coherence; Traction; Treatment Outcome; Vision Disorders; Visual Acuity; Vitreous Body; Vitreous Detachment
PubMed: 34480895
DOI: 10.1016/j.survophthal.2021.08.003 -
The Cochrane Database of Systematic... Oct 2017Symptomatic vitreomacular adhesion (sVMA) is a recognised cause of visual loss and by tradition has been managed by pars plana vitrectomy (PPV). A less invasive... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Symptomatic vitreomacular adhesion (sVMA) is a recognised cause of visual loss and by tradition has been managed by pars plana vitrectomy (PPV). A less invasive alternative to surgery in some people is enzymatic vitreolysis, using an intravitreal injection of ocriplasmin.
OBJECTIVES
To assess the efficacy and safety of ocriplasmin compared to no treatment, sham or placebo for the treatment of sVMA.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2017, Issue 1), MEDLINE Ovid (1946 to 24 February 2017), Embase Ovid (1947 to 24 February 2017), PubMed (1946 to 24 February 2017), the ISRCTN registry (www.isrctn.com/editAdvancedSearch); searched 24 February 2017, ClinicalTrials.gov (www.clinicaltrials.gov); searched 24 February 2017 and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en); searched 24 February 2017. We did not use any date or language restrictions in the electronic searches for trials.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) of people with sVMA. The intervention was intravitreal ocriplasmin 125 μg injection, and this was compared to placebo or sham injection (control). Placebo was defined as a single intravitreal injection of 0.10 mL placebo with identical drug vehicle diluted with saline. A sham injection was defined as the syringe hub or blunt needle touching the conjunctiva to simulate an injection.
DATA COLLECTION AND ANALYSIS
Two authors independently selected relevant trials, assessed methodological quality and extracted data. We graded the certainty of the evidence using the GRADE approach.
MAIN RESULTS
This review included four RCTs conducted in Europe and the USA with a total of 932 eyes of 932 participants. Participants were 18 to 97 years of age, with evidence of focal vitreomacular adhesion (VMA) on optical coherence tomography (OCT) imaging, with a best corrected visual acuity (BCVA) of 20/25 or worse in the study eye and 20/400 or better in the fellow eye. The interventions compared were intravitreal ocriplasmin versus sham (two RCTs) or placebo (two RCTs) injection. Both sham and placebo injection were classified as the control group. The main outcome measures were assessed at 28 days and six months. Overall, we judged the studies to have a low or unclear risk of bias. All four RCTs were sponsored by the manufacturers of ocriplasmin.Compared with control, ocriplasmin treatment was more likely to result in VMA release within 28 days (risk ratio (RR) 3.46, 95% confidence interval (CI) 2.00 to 6.00; 859 eyes, 4 RCTs, high-certainty evidence). Approximately 97/1000 eyes will have VMA release within 28 days without treatment. An additional 237 eyes will have VMA release within 28 days for every 1000 eyes treated with ocriplasmin (95% CI 96 more to 482 more).Treatment with ocriplasmin was also more likely to result in macular hole closure (RR 2.87, 95% CI 1.50 to 5.51; 229 eyes, 3 RCTs, high-certainty evidence). Approximately 123/1000 eyes with macular holes will have closure with no treatment. An additional 231 eyes will have macular hole closure for every 1000 eyes treated with ocriplasmin (95% CI 62 more to 556 more).Eyes receiving ocriplasmin were also more likely to have complete posterior vitreous detachment (PVD) within 28 days (RR 2.94, 95% CI 1.39 to 6.24; 689 eyes, 3 RCTs, high-certainty evidence). Approximately 40/1000 eyes will have complete PVD within 28 days without treatment. An additional 78 eyes will have complete PVD within 28 days for every 1000 eyes treated with ocriplasmin (95% CI 16 more to 210 more).Eyes receiving ocriplasmin were more likely to achieve 3-line or greater improvement in BCVA at six months (RR 1.95, 95% CI 1.07 to 3.53; 674 eyes, 3 RCTs, moderate-certainty evidence). Approximately 61/1000 eyes will have a 3-line or greater improvement in BCVA at six months without treatment. An additional 58 eyes will have 3-line or greater improvement in BCVA at six months for every 1000 eyes treated with ocriplasmin (95% CI 9 more to 154 more).Receiving ocriplasmin also reduced the requirement for vitrectomy at six months (RR 0.67, 95% CI 0.50 to 0.91; 689 eyes, 3 RCTs, moderate-certainty evidence). Approximately 265/1000 eyes will require vitrectomy at six months without treatment and 87 fewer eyes will require vitrectomy for every 1000 eyes treated with ocriplasmin (95% CI 24 fewer to 132 fewer).Treatment with ocriplasmin resulted in a greater improvement in validated Visual Function Questionnaire form score at six months (mean improvement difference 2.7 points, 95% CI 0.8 to 4.6; 652 eyes, 2 RCTs, moderate-certainty evidence).Eyes receiving ocriplasmin were more likely to have an adverse event (RR 1.22, 95% CI 1.09 to 1.37, 909 eyes, 4 RCTs, moderate-certainty evidence). Approximately 571/1000 eyes will have an adverse event with sham or placebo injection and 106 more eyes will have an adverse event for every 1000 eyes treated with ocriplasmin (95% CI 52 more to 212 more).
AUTHORS' CONCLUSIONS
Evidence from a limited number of RCTs suggests that ocriplasmin is useful in the treatment of sVMA. However, up to 20% of eyes treated with ocriplasmin will still require additional treatment with PPV within six months. There were more ocular adverse events in eyes treated with ocriplasmin than control (sham or placebo injection) treatment. Many of these adverse events, particularly vitreous floaters and photopsia, are known to be associated with posterior vitreous detachment. At present however, there is minimal published long-term safety data on eyes treated with ocriplasmin. Further large RCTs comparing ocriplasmin with other management options for sVMA would be beneficial.
Topics: Adult; Aged; Aged, 80 and over; Fibrinolysin; Fibrinolytic Agents; Humans; Intravitreal Injections; Middle Aged; Peptide Fragments; Randomized Controlled Trials as Topic; Retinal Diseases; Time Factors; Tissue Adhesions; Visual Acuity; Vitrectomy; Vitreous Body; Vitreous Detachment
PubMed: 29040800
DOI: 10.1002/14651858.CD011874.pub2 -
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