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The Lancet. Global Health Feb 2021To contribute to the WHO initiative, VISION 2020: The Right to Sight, an assessment of global vision impairment in 2020 and temporal change is needed. We aimed to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
To contribute to the WHO initiative, VISION 2020: The Right to Sight, an assessment of global vision impairment in 2020 and temporal change is needed. We aimed to extensively update estimates of global vision loss burden, presenting estimates for 2020, temporal change over three decades between 1990-2020, and forecasts for 2050.
METHODS
We did a systematic review and meta-analysis of population-based surveys of eye disease from January, 1980, to October, 2018. Only studies with samples representative of the population and with clearly defined visual acuity testing protocols were included. We fitted hierarchical models to estimate 2020 prevalence (with 95% uncertainty intervals [UIs]) of mild vision impairment (presenting visual acuity ≥6/18 and <6/12), moderate and severe vision impairment (<6/18 to 3/60), and blindness (<3/60 or less than 10° visual field around central fixation); and vision impairment from uncorrected presbyopia (presenting near vision
FINDINGS
In 2020, an estimated 43·3 million (95% UI 37·6-48·4) people were blind, of whom 23·9 million (55%; 20·8-26·8) were estimated to be female. We estimated 295 million (267-325) people to have moderate and severe vision impairment, of whom 163 million (55%; 147-179) were female; 258 million (233-285) to have mild vision impairment, of whom 142 million (55%; 128-157) were female; and 510 million (371-667) to have visual impairment from uncorrected presbyopia, of whom 280 million (55%; 205-365) were female. Globally, between 1990 and 2020, among adults aged 50 years or older, age-standardised prevalence of blindness decreased by 28·5% (-29·4 to -27·7) and prevalence of mild vision impairment decreased slightly (-0·3%, -0·8 to -0·2), whereas prevalence of moderate and severe vision impairment increased slightly (2·5%, 1·9 to 3·2; insufficient data were available to calculate this statistic for vision impairment from uncorrected presbyopia). In this period, the number of people who were blind increased by 50·6% (47·8 to 53·4) and the number with moderate and severe vision impairment increased by 91·7% (87·6 to 95·8). By 2050, we predict 61·0 million (52·9 to 69·3) people will be blind, 474 million (428 to 518) will have moderate and severe vision impairment, 360 million (322 to 400) will have mild vision impairment, and 866 million (629 to 1150) will have uncorrected presbyopia.
INTERPRETATION
Age-adjusted prevalence of blindness has reduced over the past three decades, yet due to population growth, progress is not keeping pace with needs. We face enormous challenges in avoiding vision impairment as the global population grows and ages.
FUNDING
Brien Holden Vision Institute, Fondation Thea, Fred Hollows Foundation, Bill & Melinda Gates Foundation, Lions Clubs International Foundation, Sightsavers International, and University of Heidelberg.
Topics: Aged; Aged, 80 and over; Blindness; Cataract; Eye Diseases; Female; Forecasting; Glaucoma; Global Burden of Disease; Global Health; Humans; Macular Degeneration; Male; Middle Aged; Presbyopia; Vision, Low; Visual Acuity
PubMed: 33275950
DOI: 10.1016/S2214-109X(20)30425-3 -
PloS One 2017MIGS have been developed as a surgical alternative for glaucomatous patients. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
MIGS have been developed as a surgical alternative for glaucomatous patients.
PURPOSE
To analyze the change in intraocular pressure (IOP) and glaucoma medications using different MIGS devices (Trabectome, iStent, Excimer Laser Trabeculotomy (ELT), iStent Supra, CyPass, XEN, Hydrus, Fugo Blade, Ab interno canaloplasty, Goniscopy-assisted transluminal trabeculotomy) as a solo procedure or in association with phacoemulsification.
METHODS
Randomized control trials (RCT) and non-RCT (non randomized comparative studies, NRS, and before-after studies) were included. Studies with at least one year of follow-up in patients affected by primary open angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma were considered. Risk of Bias assessment was performed using the Cochrane Risk of Bias and the ROBINS-I tools. The main outcome was the effect of MIGS devices compared to medical therapy, cataract surgery, other glaucoma surgeries and other MIGS on both IOP and use of glaucoma medications 12 months after surgery. Outcomes measures were the mean difference in the change of IOP and glaucoma medication compared to baseline at one and two years and all ocular adverse events. The current meta-analysis is registered on PROSPERO (reference n° CRD42016037280).
RESULTS
Over a total of 3,069 studies, nine RCT and 21 case series with a total of 2.928 eyes were included. Main concerns about risk of bias in RCTs were lack of blinding, allocation concealment and attrition bias while in non-RCTs they were represented by patients' selection, masking of participants and co-intervention management. Limited evidence was found based on both RCTs and non RCTs that compared MIGS surgery with medical therapy or other MIGS. In before-after series, MIGS surgery seemed effective in lowering both IOP and glaucoma drug use. MIGS showed a good safety profile: IOP spikes were the most frequent complications and no cases of infection or BCVA loss due to glaucoma were reported.
CONCLUSIONS
Although MIGS seem efficient in the reduction of the IOP and glaucoma medication and show good safety profile, this evidence is mainly derived from non-comparative studies and further, good quality RCTs are warranted.
Topics: Glaucoma, Open-Angle; Humans; Intraocular Pressure; Minimally Invasive Surgical Procedures; Ophthalmologic Surgical Procedures; Tonometry, Ocular; Treatment Outcome
PubMed: 28850575
DOI: 10.1371/journal.pone.0183142 -
Retina (Philadelphia, Pa.) May 2018Pars plana vitrectomy has been reported to increase the risk of ocular hypertension and open-angle glaucoma. The authors conducted a systematic review of randomized and... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Pars plana vitrectomy has been reported to increase the risk of ocular hypertension and open-angle glaucoma. The authors conducted a systematic review of randomized and nonrandomized studies to compare the incidence of open-angle glaucoma and ocular hypertension in vitrectomized versus nonvitrectomized eyes.
METHODS
A literature search was performed using MEDLINE and EMBASE until August 2016. Data on ocular hypertension and open-angle glaucoma incidence and mean intraocular pressure after at least 1 year were pooled using random-effects metaanalysis models. Because only nonrandomized studies were retrieved, ROBINS-I tool was used to assess risk of bias in the review.
RESULTS
Seven included studies had a paired design to compare the outcomes of vitrectomized versus fellow eyes, with mean follow-up of least 12 months. Four studies (851 patients) provided data on open-angle glaucoma: incidence in vitrectomized versus non-vitrectomized eyes was 7.8% and 4.8%, respectively, yielding a metaanalytic odds ratio of 1.67 (95% CI: 1.08-2.57). Six studies (1,060 patients) reported on the occurrence of ocular hypertension, which was 5.8% in vitrectomized eyes versus 3.1% in fellow eyes (odds ratio: 2.03, 95% CI: 0.97-4.22), without significant differences in the mean postoperative intraocular pressure (mean difference 0.31 mmHg, 95% CI: -0.26 to 0.89).
CONCLUSION
Although the review found increased risk of open-angle glaucoma with pars plana vitrectomy, the studies were heterogenous or inconsistent regarding ocular hypertension and intraocular pressure increase. Larger studies should be conducted in homogenous cohorts of patients undergoing macular surgery, excluding complex conditions such as retinal detachment or diabetic retinopathy.
Topics: Glaucoma, Open-Angle; Humans; Incidence; Intraocular Pressure; Nerve Fibers; Ocular Hypertension; Retina; Vitrectomy
PubMed: 28426628
DOI: 10.1097/IAE.0000000000001651 -
The Cochrane Database of Systematic... Feb 2020Glaucoma is a multi-factorial optic neuropathy characterized by an acquired loss of retinal ganglion cells at levels beyond normal age-related loss and corresponding... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Glaucoma is a multi-factorial optic neuropathy characterized by an acquired loss of retinal ganglion cells at levels beyond normal age-related loss and corresponding atrophy of the optic nerve. Although many treatments are available to manage glaucoma, patients may seek complementary or alternative medicine approaches such as acupuncture to supplement their regular treatment. The underlying plausibility of acupuncture is that disorders related to the flow of Chi (traditional Chinese concept of vital force or energy) can be managed by stimulating relevant points on the body surface.
OBJECTIVES
To assess the effectiveness and safety of acupuncture compared with other treatments, no treatment, or placebo in patients with glaucoma.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Eyes and Vision Trials Register (2018, Issue 11); Ovid MEDLINE; Embase.com; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); the Allied and Complementary Medicine Database (AMED); PubMed; Latin American and Caribbean Literature on Health Sciences (LILACS); ZETOC; the metaRegister of Controlled Trials (mRCT); ClinicalTrials.gov; the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP); and the National Center for Complementary and Alternative Medicine (NCCAM) website. We did not use any language or date restrictions in the search for trials. We last searched electronic databases on November 16, 2018, with the exception of NCCAM, which we last searched on July 14, 2010, and the metaRegister of Controlled Trials (mRCT), which we last searched on January 8, 2013. We handsearched Chinese medical journals at Peking Union Medical College Library in April 2007. We searched the Chinese Acupuncture Trials Register, the Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS), the Chinese Biological Database (CBM), and the China National Knowledge Infrastructure (CNKI). We last searched Chinese electronic databases on November 19, 2018.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) in which one arm involved acupuncture treatment.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened results, then extracted the data and assessed risk of bias for eligible trials.
MAIN RESULTS
We included three completed trials and one ongoing trial in the 2019 update of this review. The three completed trials, conducted in Taiwan and the United States, included participants with glaucoma or intraocular hypertension. The interventions investigated varied across trials. One trial compared auricular acupressure-a non-standard acupuncture technique-with the sham procedure in 33 patients. Another trial compared transcutaneous electrical nerve stimulation (TENS) with a sham procedure in 82 patients. The third trial compared 12 sessions of acupuncture on eye-points versus on non-eye-points in 22 patients. All three trials were rated at high risk of bias for at least one domain. The certainty of evidence across all outcomes was very low due to high risk of bias in at least one contributing study; substantial clinical heterogeneity and methodological heterogeneity; and imprecision of results. One trial reported change in the visual field from baseline without any between-group comparison. Because of the quantity of missing data (50%), we did not calculate a between-group comparison, as the quantitative results are difficult to interpret. All three trials reported data for estimation of reduction of intraocular pressure (IOP). However, time points of IOP measurement varied. For the trial comparing acupressure to a sham procedure, the difference in IOP reduction (measured in mm Hg) is estimated to be -3.70 (95% confidence interval [CI] -7.11 to -0.29) for the right eye and -4.90 (95% CI -8.08 to -1.72) for the left eye at four weeks, and -1.30 mm Hg (95% CI -4.78 to 2.18) for the right eye and -2.30 mm Hg (95% CI -5.73 to 1.13) for the left eye at eight weeks. For the trial comparing TENS to sham treatment, the difference reduction is estimated to be -2.81 (95% CI -3.8 to -1.84) for the right eye and -2.58 (95% CI -3.36 to -1.80) for the left eye immediately after treatment, -2.93 (95% CI -3.72 to -2.13) for the right eye and -3.56 (95% CI -4.35 to 2.78) for the left eye 30 minutes after treatment, and finally -3.61 (95% CI -4.47 to -2.75) for the right eye and -3.61 (95% -4.47 to -2.74) for the left eye. For the trial that compared acupuncture on eye-points versus non-eye-points, 11 out of 22 (50%) participants did not complete the treatment. One trial reported data for estimation of visual acuity. When acupressure is compared to sham treatment, the difference in uncorrected visual acuity (UCVA, measured in logMAR) is estimated to be -0.01 (95% CI -0.24 to 0.22) for the right eye and -0.04 (95% CI -0.27 to 0.19) for the left eye at four months, and -0.03 logMAR (95% CI -0.27 to 0.21) for the right eye and -0.16 logMAR (95% CI -0.43 to 0.11) for the left eye at eight months. The difference in best corrected visual acuity (BCVA) is estimated to be 0.10 (95% CI -0.06 to 0.26) for the right eye and 0 (95% CI -0.14 to 0.14) for the left eye at four months, and -0.04 logMAR (95% CI -0.09 to 0.17) for the right eye and -0.04 logMAR (95% CI -0.18 to 0.10) for the left eye at eight months. One trial reported progression of optic disc damage or nerve fiber layer loss without any between-group comparison. Because of the quantity of missing data (50%), we did not calculate a between-group comparison, as the quantitative results are difficult to interpret. One trial reported adverse events in two patients (out of 22) who experienced needle sensitivity. However, the study did not report between-group comparisons. Because of the quantity of missing data (50%), we did not calculate a between-group comparison, as the quantitative results are difficult to interpret.
AUTHORS' CONCLUSIONS
At this time, it is impossible to draw reliable conclusions from available data to support the use of acupuncture for treatment of patients with glaucoma. Because of ethical considerations, RCTs comparing acupuncture alone with standard glaucoma treatment or placebo are unlikely to be justified in countries where the standard of care has already been established.
Topics: Acupuncture Therapy; Glaucoma; Humans; Randomized Controlled Trials as Topic; Treatment Outcome; Visual Acuity
PubMed: 32032457
DOI: 10.1002/14651858.CD006030.pub4 -
Ophthalmic Research 2023The iStent (Glaukos Corporation; Laguna Hills, CA, USA) is one of the minimally invasive glaucoma devices. It can be inserted at the time of phacoemulsification or as a... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The iStent (Glaukos Corporation; Laguna Hills, CA, USA) is one of the minimally invasive glaucoma devices. It can be inserted at the time of phacoemulsification or as a stand-alone procedure to lower the intraocular pressure (IOP).
OBJECTIVE
Our aim was to conduct a systematic review and meta-analysis comparing the effect of iStent insertion at the time of phacoemulsification with phacoemulsification alone in patients with ocular hypertension or open-angle glaucoma.
METHODS
We searched EMBASE, MEDLINE (OVID and PubMed), CINAHL, and Cochrane Library for articles published between 2008 and June 2022 (PRISMA 2020 for the checklist). Studies comparing the IOP-lowering effect of iStent with phacoemulsification versus phacoemulsification alone were included. The endpoints were IOP reduction (IOPR) and the mean reduction in the number of glaucoma drops. A quality-effects model was used to compare both surgical groups.
RESULTS
Ten studies were included, reporting on 1,453 eyes. Eight hundred fifty three eyes had the combined iStent and phacoemulsification, and 600 eyes underwent phacoemulsification alone. IOPR was higher in the combined surgery at of 4.7 ± 2 mm Hg compared to 2.8 ± 1.9 mm Hg in phacoemulsification alone. A greater decrease in postoperative eye drops was noted in the combined group having a decrease of 1.2 ± 0.3 eye drops versus of 0.6 ± 0.6 drops in isolated phacoemulsification. The quality effect model showed an IOPR weighted mean difference (WMD) of 1.22 mm Hg (confidence interval [CI]: [-0.43, 2.87]; Q = 315.64; p < 0.01; I2 = 97%) and decreased eye drops WMD 0.42 drops (CI: [0.22, 0.62]; Q = 42.6; p < 0.01; I2 = 84%) between both surgical groups. Subgroup analysis shows that the new generation iStent may be more effective in reducing IOP.
CONCLUSION
iStent has a synergetic effect with phacoemulsification. The reduction of IOP and glaucoma eye drops was higher when iStent is combined with phacoemulsification compared with isolated phacoemulsification.
Topics: Humans; Phacoemulsification; Glaucoma, Open-Angle; Glaucoma Drainage Implants; Glaucoma; Intraocular Pressure; Trabecular Meshwork; Ophthalmic Solutions
PubMed: 37245507
DOI: 10.1159/000531077 -
Graefe's Archive For Clinical and... Jan 2024The association of obstructive sleep apnea (OSA) with development of eye diseases is unclear. This current systematic review and meta-analysis attempts to summarize and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The association of obstructive sleep apnea (OSA) with development of eye diseases is unclear. This current systematic review and meta-analysis attempts to summarize and analyze associations between OSA and ocular disorders in the literature.
METHODS
PubMed, EMBASE, Google Scholar, Web Of Science, and Scopus databases were searched from 1901 to July 2022 in accordance with the Preferred Reporting in Systematic Review & Meta-Analysis (PRISMA). Our primary outcome assessed the association between OSA and the odds of developing floppy eyelid syndrome (FES), glaucoma, non-arteritic anterior ischemic optic neuropathy (NAION), retinal vein occlusion (RVO), keratoconus (KC), idiopathic intracranial hypertension (IIH), age-related macular degeneration (AMD), and central serous chorioretinopathy (CSR) through odds ratio calculated at the 95% confidence interval.
RESULTS
Forty-nine studies were included for systematic review and meta-analysis. The pooled OR estimate was highest for NAION [3.98 (95% CI 2.38, 6.66)], followed by FES [3.68 (95% CI 2.18, 6.20)], RVO [2.71(95% CI 1.83, 4.00)], CSR [2.28 (95% CI 0.65, 7.97)], KC [1.87 (95% CI 1.16, 2.99)], glaucoma [1.49 (95% CI 1.16, 1.91)], IIH [1.29 (95% CI 0.33, 5.01)], and AMD [0.92 [95% CI 0.24, 3.58] All observed associations were significant (p < 0.001) aside from IIH and AMD.
CONCLUSION
OSA is significantly associated with NAION, FES, RVO, CSR, KC, and glaucoma. Clinicians should be informed of these associations so early recognition, diagnosis, and treatment of eye disorders can be addressed in at-risk groups, and early referral to ophthalmic services is made to prevent vision disturbances. Similarly, ophthalmologists seeing patients with any of these conditions should consider screening and referring patients for assessment of possible OSA.
Topics: Humans; Eyelid Diseases; Glaucoma; Keratoconus; Optic Neuropathy, Ischemic; Retinal Vein Occlusion; Sleep Apnea, Obstructive
PubMed: 37227479
DOI: 10.1007/s00417-023-06103-3 -
Acta Ophthalmologica Mar 2022Intraocular pressure is the main risk factor for glaucoma; however, additional risk factors may also matter. This systematic review and meta-analysis were conducted to... (Meta-Analysis)
Meta-Analysis
PURPOSE
Intraocular pressure is the main risk factor for glaucoma; however, additional risk factors may also matter. This systematic review and meta-analysis were conducted to summarize the evidence regarding the association of cholesterol parameters (total cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) levels) and glaucoma.
METHODS
Four electronic databases were searched for all publications containing 'glaucoma' and one of various forms of 'cholesterol' or 'lipoprotein'. Two independent reviewers screened abstracts and potentially full texts of identified articles for eligibility. Risk of bias was assessed with the Newcastle-Ottawa Scale. A random-effects meta-analysis was used to investigate the differences in total cholesterol, LDL and HDL levels between patients with and without glaucoma.
RESULTS
Overall, 29 observational studies were included in the systematic review and 26 reported quantitative information to investigate differences in cholesterol parameters between patients with glaucoma (N = 7196) and patients without glaucoma (N = 350 441). Patients with glaucoma had significantly higher total cholesterol levels than patients without glaucoma (Mean Difference (MD) 7.9 mg/dl, 95% CI 3.3 to 12.5, p = 0.001) and lower mean HDL levels (MD -2.0 mg/dl, 95% CI: -3.1 to -0.9, p = 0.001). Patients with glaucoma had higher mean LDL levels than patients without glaucoma, albeit not statistically significant (MD 6.1 mg/dl, 95% CI: -4.3 to 16.4, p = 0.251).
CONCLUSION
This systematic review and meta-analysis of observational studies found an association of glaucoma and high total cholesterol and low HDL levels, respectively. Although this supports the hypothesis that lipid levels pose an additional risk for glaucoma development, heterogeneity was substantial and causality cannot be presumed from identified observational studies.
Topics: Adult; Aged; Case-Control Studies; Causality; Cholesterol, HDL; Cholesterol, LDL; Female; Glaucoma; Humans; Male; Middle Aged; Observational Studies as Topic; Risk Factors
PubMed: 33506616
DOI: 10.1111/aos.14769 -
Romanian Journal of Ophthalmology 2015The objective of our study was to review the current knowledge on the diagnosis and treatment options of plateau iris configuration and syndrome. (Review)
Review
OBJECTIVES
The objective of our study was to review the current knowledge on the diagnosis and treatment options of plateau iris configuration and syndrome.
SYSTEMATIC REVIEW METHODOLOGY
Relevant publications on plateau iris that were published until 2014.
CONCLUSIONS
Plateau iris syndrome is a form of primary angle closure glaucoma caused by a large or anteriorly positioned ciliary body that leads to mechanical obstruction of trabecular meshwork. This condition is most often found in younger patients. Plateau iris has been considered an abnormal anatomic variant of the iris that can be diagnosed on ultrasound biomicroscopy or optical coherence tomography of anterior segment. Patients with plateau iris syndrome can be recognized by the lack of response in angle opening after iridotomy. The treatment of choice in these cases is argon laser peripheral iridoplasty.
Topics: Argon; Ciliary Body; Diagnosis, Differential; Glaucoma, Angle-Closure; Humans; Iridectomy; Iris; Laser Therapy; Microscopy, Acoustic; Syndrome; Tomography, Optical Coherence; Trabecular Meshwork; Treatment Outcome
PubMed: 27373109
DOI: No ID Found -
Eye (London, England) Oct 2023Obstructive sleep apnoea (OSA) has been thought to be associated with glaucoma, however there are many conflicting studies on this topic. With many new studies having... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Obstructive sleep apnoea (OSA) has been thought to be associated with glaucoma, however there are many conflicting studies on this topic. With many new studies having been published since the previous meta-analysis, we believe it is important to clarify this association. Hence, in this study we meta-analyse the recent literature regarding the association between OSA and glaucoma.
METHODS
Pubmed, Embase, Scopus and Cochrane Library were searched from inception till the 28th February 2022 for observational as well as cross-sectional studies examining the association between OSA and glaucoma. Two reviewers selected studies, extracted data, graded the quality of included non-randomized studies using the Newcastle-Ottawa scale. The overall quality of evidence was assessed using GRADE. Random-effects models were used to meta-analyse the maximally covariate- adjusted associations.
RESULTS
48 studies were included in our systematic review, with 46 suitable for meta-analysis. Total study population was 4,566,984 patients. OSA was associated with a higher risk of glaucoma (OR 3.66, 95% CI 1.70 to 7.90, I = 98%, p < 0.01). After adjustment for various important confounders including age, gender and patient comorbidities such as hyperlipidaemia, hypertension, cardiovascular diseases and diabetes, patients with OSA had up to 40% higher odds of glaucoma. Substantial heterogeneity was eliminated through subgroup and sensitivity analyses after consideration of glaucoma subtype, OSA severity and adjustment for confounders.
CONCLUSIONS
In this meta-analysis, OSA was associated with higher risk of glaucoma, as well as more severe ocular findings characteristic of the glaucomatous disease process. We suggest more clinical studies looking into the effects of OSA treatment on the progression of glaucoma to help clinical decision making for patients.
Topics: Humans; Cross-Sectional Studies; Sleep Apnea, Obstructive; Glaucoma; Cardiovascular Diseases; Data Collection
PubMed: 36977937
DOI: 10.1038/s41433-023-02471-6 -
The Cochrane Database of Systematic... Mar 2023Glaucoma is an optic neuropathy that leads to visual field defects and vision loss. It is the second leading cause of irreversible blindness in the world. Treatment for... (Review)
Review
BACKGROUND
Glaucoma is an optic neuropathy that leads to visual field defects and vision loss. It is the second leading cause of irreversible blindness in the world. Treatment for glaucoma aims to reduce intraocular pressure (IOP) to slow or prevent further vision loss. IOP can be lowered with medications, laser, or incisional surgery. Trabeculectomy is a surgical approach which lowers IOP by shunting aqueous humor to a subconjunctival bleb. Device-modified trabeculectomy techniques are intended to improve the durability and safety of this bleb-forming surgery. Trabeculectomy-modifying devices include the Ex-PRESS, the XEN Gel Stent, the PreserFlo MicroShunt, as well as antifibrotic materials such as Ologen, amniotic membrane, expanded polytetrafluoroethylene (ePTFE) membrane, Gelfilm and others. However, the comparative effectiveness and safety of these devices are uncertain.
OBJECTIVES
To evaluate the benefits and harms of different devices as adjuncts to trabeculectomy on IOP control in eyes with glaucoma compared to standard trabeculectomy.
SEARCH METHODS
We used standard, extensive Cochrane search methods. The latest search was August 2021.
SELECTION CRITERIA
We included randomized controlled trials in participants with glaucoma comparing device-modified trabeculectomy techniques with standard trabeculectomy. We included studies that used antimetabolites in either or both treatment groups.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were 1. change in IOP and 2. mean postoperative IOP at one year. Our secondary outcomes were 3. mean change in IOP from baseline, 4. mean postoperative IOP at any time point, 5. mean best-corrected visual acuity (BCVA), 6. visual field change, 7. quality of life, 8. proportion of participants who are drop-free at one year, 9. mean number of IOP lowering medications at one year, and 10. proportion of participants with complications.
MAIN RESULTS
Eight studies met our inclusion criteria, of which seven were full-length journal articles and one was a conference abstract. The eight studies included 961 participants with glaucoma, and compared two types of devices implanted during trabeculectomy versus standard trabeculectomy. Seven studies (462 eyes, 434 participants) used the Ex-PRESS, and one study (527 eyes, 527 participants) used the PreserFlo MicroShunt. No studies using the XEN Gel Stent implantation met our criteria. The studies were conducted in North America, Europe, and Africa. Planned follow-up periods ranged from six months to five years. The studies were reported poorly, which limited our ability to judge risk of bias for many domains. None of the studies explicitly masked outcome assessment. We rated seven studies at high risk of detection bias. Low-certainty of evidence from five studies showed that using the Ex-PRESS plus trabeculectomy compared with standard trabeculectomy may be associated with a slightly lower IOP at one year (mean difference (MD) -1.76 mmHg, 95% confidence interval (CI) -2.81 to -0.70; 213 eyes). Moderate-certainty of evidence from one study showed that using the PreserFlo MicroShunt may be associated with a slightly higher IOP than standard trabeculectomy at one year (MD 3.20 mmHg, 95% CI 2.29 to 4.11). Participants who received standard trabeculectomy may have a higher risk of hypotony compared with those who received device-modified trabeculectomy, but the evidence is uncertain (RR 0.73, 95% CI 0.46 to 1.17; I² = 38%; P = 0.14). In the subgroup of participants who received the PreserFlo MicroShunt, there was a lower risk of developing hypotony or shallow anterior chamber compared with those receiving standard trabeculectomy (RR 0.44, 95% CI 0.25 to 0.79; 526 eyes). Device-modified trabeculectomy may lead to less subsequent cataract surgery within one year (RR 0.46, 95% CI 0.27 to 0.80; I² = 0%).
AUTHORS' CONCLUSIONS
Use of an Ex-PRESS plus trabeculectomy may produce greater IOP reduction at one-year follow-up than standard trabeculectomy; however, due to potential biases and imprecision in effect estimates, the certainty of evidence is low. PreserFlo MicroShunt may be inferior to standard trabeculectomy in lowering IOP. However, PreserFlo MicroShunt may prevent postoperative hypotony and bleb leakage. Overall, device-modified trabeculectomy appears associated with a lower risk of cataract surgery within five years compared with standard trabeculectomy. Due to various limitations in the design and conduct of the included studies, the applicability of this evidence synthesis to other populations or settings is uncertain. Further research is needed to determine the effectiveness and safety of other devices in subgroup populations, such as people with different types of glaucoma, of various races and ethnicity, and with different lens types (e.g. phakic, pseudophakic).
Topics: Humans; Cataract; Glaucoma; Intraocular Pressure; Quality of Life; Randomized Controlled Trials as Topic; Trabeculectomy
PubMed: 36912740
DOI: 10.1002/14651858.CD010472.pub3