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Meta-Analysis
. 2019 Mar 28;3(3):CD012743.
doi: 10.1002/14651858.CD012743.pub2.

Ab interno trabecular bypass surgery with iStent for open-angle glaucoma

Jimmy T Le  1 , Amanda K Bicket, Lin Wang, Tianjing Li
Affiliations
Meta-Analysis

Ab interno trabecular bypass surgery with iStent for open-angle glaucoma

Jimmy T Le et al. Cochrane Database Syst Rev. .

Abstract

Background: Glaucoma is a leading cause of irreversible blindness worldwide. In early stages, glaucoma results in progressive loss of peripheral (side) vision; in later stages, it results in loss of central vision leading to blindness. Elevated intraocular pressure (IOP) is the only known modifiable risk factor for glaucoma. Minimally invasive glaucoma surgical (MIGS) techniques, such as ab interno trabecular bypass surgery with iStent (Glaukos Corporation, Laguna Hills, CA, USA), have been introduced as a new treatment modality for glaucoma. However, the effectiveness of MIGS on keeping people 'drop-free' (i.e. not having to use eye drops to control IOP) and other outcomes is uncertain.

Objectives: To assess the effectiveness and safety of ab interno trabecular bypass surgery with iStent (or iStent inject) for open-angle glaucoma in comparison to conventional medical, laser, or surgical treatment.

Search methods: Cochrane Eyes and Vision's Information Specialist searched the following databases on 17 August 2018: the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register; 2018, Issue 7), MEDLINE Ovid, Embase Ovid, the ISRCTN registry, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We applied no date or language restrictions. We searched the reference lists of reports from included studies.

Selection criteria: We included randomized controlled trials (RCTs) that had compared iStent or iStent inject to medical therapy, laser treatment, conventional glaucoma surgery (trabeculectomy), or other MIGS procedures. We included RCTs that had compared iStent or iStent inject in combination with phacoemulsification to phacoemulsification alone.

Data collection and analysis: We used standard methodological procedures expected by Cochrane. Two review authors independently screened search results, assessed risk of bias, and extracted data from reports of included RCTs using an electronic data collection form.

Main results: We included seven RCTs (765 eyes of 764 participants; range per study 33 to 239 participants) that evaluated iStent in people with open-angle glaucoma. We also identified 13 studies that are ongoing or awaiting publications of results. Most participants in the included studies were women (417/764 (55%) participants) and older age (age range: 49 to 89 years). We assessed most trials at unclear or high risk of bias: four trials did not clearly report the method of generating the random sequence or concealing allocation; five were unmasked, open-label studies, which we assessed at high risk of bias for performance and detection bias. All seven trials were funded by the Glaukos Corporation. We graded the certainty of evidence as very low.Four RCTs compared iStent in combination with phacoemulsification to phacoemulsification alone. The summary estimate which we derived from two of the four RCTs suggested that participants in the iStent in combination with phacoemulsification group were 1.38 times more likely to be drop-free between six and 18 months than those in the phacoemulsification alone group (risk ratio (RR) 1.38, 95% confidence interval (CI) 1.18 to 1.63, I2 = 67%). Data from two RCTs also suggested that iStent in combination with phacoemulsification compared to phacoemulsification alone may have offered a small reduction in number of IOP-lowering drops (mean difference (MD) -0.42 drops, 95% CI -0.60 to -0.23). It is uncertain whether there was any difference in terms of mean reduction in IOP from baseline (no meta-analysis).Two RCTs compared treatment with iStent to medical therapy; one of the two trials used the iStent inject. We determined the two trials to be clinically and methodologically heterogeneous and did not conduct a meta-analysis; however, the investigators of both trials reported that over 90% of participants in the treatment groups were drop-free compared to no participants in the medical therapy groups at six to 18 months.One RCT compared treatment with one versus two versus three iStents. There was no difference in terms of participants who were drop-free at 36 months or less; however, at longer follow-up (i.e. at 42 months) participants in the one iStent treatment were less likely to be drop-free than those in the two iStent (RR 0.51, 95% CI 0.34 to 0.75) or three iStent (RR 0.49, 95% CI 0.34 to 0.73) treatment groups. The study did not report the mean change in number of IOP-lowering drops.The type and timing of complications reported varied by RCTs. Similar proportions of participants who underwent treatment with iStent in combination with phacoemulsification and who underwent phacoemulsification alone needed secondary glaucoma surgery. None of RCTs reported findings related to quality of life.

Authors' conclusions: There is very low-quality evidence that treatment with iStent may result in higher proportions of participants who are drop-free or achieving better IOP control, in the short, medium, or long-term. Results from the 13 studies with results not yet available may clarify the benefits of treatment of people with iStent. Additionally, future MIGS studies should consider measuring quality of life and outcomes that reflect people's ability to perform vision-dependent activities.

PubMed Disclaimer

Conflict of interest statement

JL: This Cochrane Review was prepared while Dr. Le was a doctoral candidate at the Johns Hopkins Bloomberg School of Public Health. The opinions expressed in this article are the author's own and do not reflect the view of the National Institutes of Health, the Department of Health and Human Services, or the United States government. AB: none. LW: none. TL: none.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgments about each risk of bias item for each included study.
3
3
Forest plot of comparison: 1 iStent in combination with phacoemulsification versus phacoemulsification alone, outcome: 1.1 Proportion of participants who were drop‐free.
4
4
Forest plot of comparison: 1 iStent in combination with phacoemulsification versus phacoemulsification alone, outcome: 1.2 Mean change in number of intraocular pressure (IOP)‐lowering drops taken per day from baseline.
5
5
Forest plot of comparison: 1 iStent in combination with phacoemulsification versus phacoemulsification alone, outcome: 1.3 Mean change in IOP.
6
6
Forest plot of comparison: 3 One iStent (without phacoemulsification) versus two iStents (without phacoemulsification), outcome: 3.1 Proportion of participants who were drop‐free.
7
7
Forest plot of comparison: 4 One iStent (without phacoemulsification) versus three iStents (without phacoemulsification), outcome: 4.1 Proportion of participants who were drop‐free.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Fea 2010 {published data only}
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Fea 2014 {published data only}
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Fernandez‐Barrientos 2010 {published data only}
    1. Fernandez‐Barrientos Y, Garcia‐Feijoo J, Martinez‐de‐la‐Casa JM, Pablo LE, Fernandez‐Perez C, Garcia Sanchez J. Fluorophotometric study of the effect of the Glaukos trabecular microbypass stent on aqueous humor dynamics. Investigative Ophthalmology and Visual Science 2010;51(7):3327‐32. - PubMed
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Katz 2015 {published data only}
    1. Katz LJ, Erb C, Carceller GA, Fea AM, Voskanyan L, Wells JM, et al. Prospective, randomized study of one, two, or three trabecular bypass stents in open‐angle glaucoma subjects on topical hypotensive medication. Clinical Ophthalmology 2015;9:2313‐20. - PMC - PubMed
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NCT00721968 {unpublished data only}
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    1. Vold SD, Voskanyan L, Tetz M, Auffarth G, Masood I, Au L, et al. Erratum to: newly diagnosed primary open‐angle glaucoma randomized to 2 trabecular bypass stents or prostaglandin: outcomes through 36 months. Ophthalmology and Therapy 2016; Vol. 5, issue 2:173. - PMC - PubMed
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References to studies excluded from this review

Bacharach 2014 {published data only}
    1. Bacharach J. Efficacy of trabecular bypass stent through 2 years: data from the United States pivotal trial. Journal of Cataract and Refractive Surgery 2014; Vol. 40, issue 8:1325‐6. - PubMed
NCT03274323 {published data only}
    1. NCT03274323. Trabeculectomy versus 2‐iStent and prostaglandin study (TIPS). clinicaltrials.gov/ct2/show/NCT03274323 (first received 6 September 2017).
Vlasov 2017 {published data only}
    1. Vlasov A, Kim WI. The efficacy of two trabecular bypass stents compared to one in the management of open‐angle glaucoma. Military Medicine 2017;182(S1):222‐5. - PubMed

References to ongoing studies

EUCTR2009‐018066‐36‐ES {published data only}
    1. EUCTR2009‐018066‐36‐ES. Open prospective randomized evaluation of iStent® (GTS400) versus two ocular hypotensive agents in patients with primary open‐angle glaucoma (Google translation) [Evaluación aleatorizada prospectiva en abierto del iStent® (GTS400) frente a dos agentes hipotensores oculares en pacientes con glaucoma primario de ángulo abierto – second line study]. apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2009‐018066‐36‐ES (first received 11 March 2010).
NCT00326079 {published data only}
    1. NCT00326079. A study of the Glaukos trabecular micro‐bypass stent in open angle glaucoma subjects 1 stent versus 2. clinicaltrials.gov/ct2/show/study/NCT00326079 (first received 16 May 2016).
NCT01052558 {published data only}
    1. NCT01052558. GTS400 stent implantation in conjunction with cataract surgery in subjects with open‐angle glaucoma. clinicaltrials.gov/ct2/show/NCT01052558 (first received 20 January 2010).
NCT01252849 {published data only}
    1. NCT01252849. Purpose of this study is to evaluate the safety and efficacy of one, two, or three iStents for the reduction of intraocular pressure in open‐angle glaucoma subjects. clinicaltrials.gov/ct2/show/NCT01252849 (first received 3 December 2010).
NCT01444040 {published data only}
    1. NCT01444040. Subjects with open‐angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy, treated with two trabecular micro‐bypass stents (iStent inject) or travoprost. clinicaltrials.gov/ct2/show/NCT01444040 (first received 30 September 2011).
NCT01444105 {published data only}
    1. NCT01444105. Open‐angle glaucoma subjects on one ocular hypotensive medication randomized to treatment with two trabecular micro‐bypass stents or selective laser trabeculoplasty. clinicaltrials.gov/ct2/show/NCT01444105 (first received 30 September 2011).
NCT01455467 {published data only}
    1. NCT01455467. Open‐angle glaucoma subjects on one topical hypotensive medication randomized to treatment with one or two trabecular micro‐bypass stents in conjunction with cataract surgery. clinicaltrials.gov/ct2/show/NCT01455467 (first received 20 October 2011).
NCT01461291 {published data only}
    1. NCT01461291. Multicenter study using Glaukos® trabecular micro‐bypass stent model GTS400 using the G2‐M‐IS injector system in conjunction with cataract surgery. clinicaltrials.gov/ct2/show/NCT01461291 (first received 28 October 2011).
NCT02023242 {published data only}
    1. NCT02023242. Comparing effectiveness of the Hydrus Microstent (TM) to two iStents to lower IOP in phakic eyes (COMPARE) [A prospective, multicenter, randomized comparison of the Hydrus to the iStent® for lowering intraocular pressure in primary open angle glaucoma]. clinicaltrials.gov/ct2/show/study/NCT02023242 (first received 30 December 2013).
NCT02024464 {published data only}
    1. NCT02024464. Comparing Hydrus Microstent(TM) to the iStent for lowering IOP in glaucoma patients undergoing cataract surgery. clinicaltrials.gov/ct2/show/NCT02024464 (first received 31 December 2013).
NCT02327312 {published data only}
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NCT03106181 {published data only}
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UMIN000027734 {published data only}
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