A review of the iStent^® trabecular micro-bypass stent: safety and efficacy

Figures & data

Table 1 iStent randomized controlled trials: summary of results

Study	Treatment group (n= number of eyes)	Control group (n= number of eyes)	Follow-up (months)	Attrition rate, treatment group/control group (%)	Treatment group mean IOP reduction (%)	Control group mean IOP change (% reduction)	Treatment group mean medications (% reduction)	Control group mean medications (% reduction)
Fea^Citation14	Phaco +1 iStent (n=12)	Phaco (n=24)	15	0.0/12.5	17.3*	9.2	80*	31.6
Fernández-Barrientos et al^Citation15	Phaco +2 iStents (n=17)	Phaco (n=16)	12	0.0/0.0	27.3**	16.5	100*	41.7
Samuelson et al^Citation10	Phaco +1 iStent (n=117)	Phaco (n=123)	12	9.4/8.9	8.2	5.4	86.7*	73.3
Craven et al^Citation13	Phaco +1 iStent (n=117)	Phaco (n=123)	24	16.2/17.9	8.1	4.3	80.0	66.7

Notes: The values listed under the columns “mean IOP change” and “mean medications” indicate the reduction from baseline. P-values where available from original publication:

* P<0.05,

** P<0.005.

Abbreviations: IOP, intraocular pressure; phaco, phacoemulsification.

Table 2 iStent prospective case series: summary of results

Study	Treatment (n= number of eyes)	Follow-up (months)	Attrition rate (%)	Mean IOP change (% reduction)	Mean medications (% reduction)
	iStent
Spiegel et al^Citation17	1 iStent (n=6)	12	0.0	23.90	18.5
Buchacra et al^Citation18	1 iStent (n=10)	12	20.0	27.30*	62.0*
Ahmed et al^Citation16	2 iStents (n=39) + travoprost	18	0.0	46.90	50
	Phacoemulsification + iStent
Spiegel et al^Citation20	Phaco +1 iStent (n=47)	6	0.0	25.40***	66.7***
Spiegel et al^Citation22	Phaco +1 iStent (n=47)	12	10.6	21.40***	75.0***
Arriola-Villalobos et al^Citation21	Phaco +1 iStent (n=19)	60	31.6	16.33*	63.6*
Patel et al^Citation19	Phaco +1 iStent (n=44)	6	0.0	20.90**	74.3**
	Phacoemulsification + multiple iStents
Belovay et al^Citation23	Phaco +2 iStents (n=28)	12	0.0	20.2% reduction***	64.3% reduction***
	Phaco +3 iStents (n=25)	12	0.0	20.4% reduction***	84.6% reduction***

Notes: Values listed under the columns “mean IOP change” and “mean medications” indicate the reduction from baseline. P-values where available from original publication:

* P<0.05,

** P<0.01,

*** P<0.001.

Abbreviations: IOP, intraocular pressure; phaco, phacoemulsification.

Table 3 iStent Inject clinical studies: summary of results

Study	Design	Treatment (n= number of eyes)	Follow-up (months)	Attrition rate (%)	Mean IOP change (% reduction)	Mean medications (% reduction)
Fea et al^Citation24	RCT	Treatment (2 iStent Inject) (n=94) vs control (medication) (n=98)	12	Treatment 0.0 vs control 7.1	Treatment 38.40 vs control 36.20*	NA
Arriola-Villalobos et al^Citation26	Case series	Phaco +1 iStent Inject (n=3) Phaco +2 iStent Inject (n=17)	12	0.0	35.68**	76.9**
Voskanyan et al^Citation25	Case series	2 iStent Inject (n=99)	12	7.1	39.70	Data not provided

Notes: The values listed under the columns “mean IOP change” and “mean medications” indicate the reduction from baseline. P-values where available from original publication:

* P<0.05,

** P<0.001.

Abbreviations: IOP, intraocular pressure; NA, not applicable; phaco, phacoemulsification; RCT, randomized controlled trial; vs, versus.

FeaAMPhacoemulsification versus phacoemulsification with micro-bypass stent implantation in primary open-angle glaucoma: randomized double-masked clinical trialJ Cataract Refract Surg201036340741220202537

 PubMed Web of Science ®Google Scholar

Fernández-BarrientosYGarcía-FeijoóJMartínez-de-la-CasaJMPabloLEFernández-PérezCGarcía SánchezJFluorophotometric study of the effect of the glaukos trabecular microbypass stent on aqueous humor dynamicsInvest Ophthalmol Vis Sci20105173327333220207977

 PubMed Web of Science ®Google Scholar

SamuelsonTWKatzLJWellsJMDuhYJGiamporcaroJEUS iStent Study GroupRandomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataractOphthalmology2011118345946720828829

 PubMed Web of Science ®Google Scholar

CravenERKatzLJWellsJMGiamporcaroJEiStent Study GroupCataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-upJ Cataract Refract Surg20123881339134522814041

 PubMed Web of Science ®Google Scholar

SpiegelDWetzelWHaffnerDSHillRAInitial clinical experience with the trabecular micro-bypass stent in patients with glaucomaAdv Ther200724116117017526473

 PubMed Web of Science ®Google Scholar

BuchacraODuchSMillaEStirbuOOne-year analysis of the iStent trabecular microbypass in secondary glaucomaClin Ophthalmol2011532132621468340

 PubMedGoogle Scholar

AhmedIIKatzLJChangDFProspective evaluation of microinvasive glaucoma surgery with trabecular microbypass stents and prostaglandin in open-angle glaucomaJ Cataract Refract Surg20144081295130025088627

 PubMed Web of Science ®Google Scholar

SpiegelDGarcía-FeijoóJGarcía-SánchezJLamielleHCoexistent primary open-angle glaucoma and cataract: preliminary analysis of treatment by cataract surgery and the iStent trabecular micro-bypass stentAdv Ther200825545346418594784

 PubMed Web of Science ®Google Scholar

SpiegelDWetzelWNeuhannTCoexistent primary open-angle glaucoma and cataract: interim analysis of a trabecular micro-bypass stent and concurrent cataract surgeryEur J Ophthalmol200919339339919396784

 PubMed Web of Science ®Google Scholar

Arriola-VillalobosPMartínez-de-la-CasaJMDíaz-ValleDFernández-PérezCGarcía-SánchezJGarcía-FeijoóJCombined iStent trabecular micro-bypass stent implantation and phacoemulsification for coexistent open-angle glaucoma and cataract: a long-term studyBr J Ophthalmol20126564564922275344

 PubMed Web of Science ®Google Scholar

PatelIde KlerkTAAuLManchester iStent study: early results from a prospective UK case seriesClin Experiment Ophthalmol201341764865223448425

 PubMed Web of Science ®Google Scholar

BelovayGWNaqiAChanBJRatebMAhmedIIUsing multiple trabecular micro-bypass stents in cataract patients to treat open-angle glaucomaJ Cataract Refract Surg201238111911191722980724

 PubMed Web of Science ®Google Scholar

FeaAMBeldaJIRękasMProspective unmasked randomized evaluation of the iStent inject (®) versus two ocular hypotensive agents in patients with primary open-angle glaucomaClin Ophthalmol2014887588224855336

 PubMedGoogle Scholar

Arriola-VillalobosPMartínez-de-la-CasaJMDíaz-ValleDMidterm evaluation of the new Glaukos iStent with phacoemulsification in coexistent open-angle glaucoma or ocular hypertension and cataractBr J Ophthalmol201397101250125523603758

 PubMed Web of Science ®Google Scholar

VoskanyanLGarcía-FeijoóJBeldaJIFeaAJünemannABaudouinCSynergy Study GroupProspective, unmasked evaluation of the iStent® inject system for open-angle glaucoma: synergy trialAdv Ther201431218920124452726

 PubMed Web of Science ®Google Scholar