Experimental Eye Research 88 (2009) 792–798

Contents lists available at ScienceDirect

Experimental Eye Research

journal homepage: www.elsevier.com/locate/yexer

Review

Use of novel devices for control of intraocular pressure

Don S. Minckler*, Richard A. Hill
Univ. CA Irvine, Ophthalmology, 118 Med Surg I, Irvine, CA 92697-4375, United States

a r t i c l e i n f o a b s t r a c t

Article history: This brief review in honor of Douglas Johnson, MD describes the rationales and initial clinical outcomes
Received 3 July 2008 in studies to date on TrabectomeÒ, Glaukos iStentÔ, iScience (canaloplasty), and Solx (suprachoroidal
Accepted in revised form 4 November 2008 shunt), all newly developed surgical technologies for treatment of open-angle glaucomas. These new
Available online 30 November 2008
approaches to angle surgery have been demonstrated in preliminary case series to safely lower IOP in the
mid-teens with far fewer complications than expected with trabeculectomy and without anti-fibrotics.
Keywords:
Trabectome and iStent are relatively non-invasive, aim to improve access of aqueous to collector channels
NeoMedix
and do not preclude subsequent standard surgery. Canaloplasty, modified from viscocanalostomy, is
Trabectome
Glaukos iStent thought to improve trans-trabecular flow. Solx potentially offers an adjustable aqueous outflow into the
iScience suprachoroidal space.
canaloplasty Ó 2008 Elsevier Ltd. All rights reserved.
Solx gold suprachoroidal shunt
open-angle glaucoma
ab interno surgery

Commentary in this review is limited to TrabectomeÒ, Glaukos concepts about the quality of evidence presented in peer reviewed
iStentÔ, iScience (canaloplasty), and Solx (trans-limbal supra- publications, a combination scheme including the American Acade-
choroidal shunt), all recently developed technologies that offer hope my’s rating system and the Oxford system is included below
of improving our ability to surgically normalize intraocular pressure (Table 1). The AAO scheme rates evidence as Level I (high), Level II
(IOP) in patients with chronic open-angle glaucoma. Trabectome (medium), or Level III (low). The Oxford system provides more detail
and iStent are substantially less invasive than the current ‘‘gold and several additional levels. The definitions of commonly used
standard’’ trabeculectomy and none of the four new techniques study designs in clinical vision literature can generally be divided
depend on external filtering bleb formation or require adjunctive into interventional (medical or surgical therapy), observational (no
anti-fibrotic agents such as 5-flurouracil or mitomycin-C, both of intervention), or other (meta-analyses and systematic reviews). To
which greatly increase the risks of short and longer-term compli- date none of the new technologies for glaucoma surgical therapy
cations including immediate hypotony and late blebitis. All have discussed here can be considered well-supported by high level
only recently reached the marketplace and have yet to demonstrate evidence as they have few publications and none including
long-term efficacy in case series with extended follow-up or be a randomized trial comparing them to each other or other existing
directly compared to trabeculectomy or to each other in randomized therapies. For current perspectives on the quality of peer reviewed
trials. Including this brief review in this issue honoring Douglas published evidence, readers are advised to view the CONSORT
Johnson is particularly appropriate as he was directly involved with statement (http://www.consort-statement.org/?o¼1011) on
both Trabectome (Figs. 1 and 2) and Glaukos research and devel- randomized trials, detailing items to be included in the highest level
opment (Bahier et al., 2004); (Ahou and Smedley, 2005) and their studies. For observational studies (no therapy) readers may refer to
ongoing clinical evaluations. He had performed several Trabectome the recently published STROBE document http://www.annals.org/
procedures on his own patients before his untimely death. cgi/content/full/147/8/573. Guidelines for evaluating interventional
The order and amount of commentary herein on each new case series constituting the only available peer reviewed literature on
technology is proportioned based only on the availability of pub- the four technologies discussed here have been published in
lished data including the number of reported patients, to date limited Ophthalmology (Minckler, 1999).
to non-comparative case series. Trabectome and iStent are discussed
sequentially as they are similar in rationales. In keeping with current 1. TrabectomeÒ (AAO/Oxford level III/4 evidence)

* Corresponding author. Tel.: þ1 949 824 8089; fax: þ1 949 824 7645. The Trabectome (NeoMedix, Tustin, CA) first utilized and
E-mail address: [email protected] (D.S. Minckler). reported as a case series in Mexico in 2005 (Minckler et al., 2005)

0014-4835/$ – see front matter Ó 2008 Elsevier Ltd. All rights reserved.
doi:10.1016/j.exer.2008.11.010
 D.S. Minckler, R.A. Hill / Experimental Eye Research 88 (2009) 792–798 793

Fig. 1. Trabectome console, foot pedal, and handpiece (courtesy of NeoMedix).

then as an expanding case series in 2006 (Minckler et al., 2006, angle surgery in children and adults as it includes removal of a strip
2008) and (Francis et al., 2006 ), utilizes an electric spark to ablate of meshwork and aspiration of tissue debris reducing the inflam-
the meshwork and inner wall of Schlemm’s canal via gonioscopic matory stimuli and opportunity for scarring among shards of
surgery (Trabectome gonioprism, Ocular Instruments, Bellevue, incised or ruptured tissues remaining after traditional goniotomy
WN). The rationale for this device is based on the long-held view or trabeculotomy (Fig. 1).
that the main resistance to aqueous outflow resides in the outer The Trabectome’s design includes a pointed ceramic coated
portion of the trabecular meshwork and the juxta-cannalicular insulating footplate sized to fit into Schlemm’s canal. The Tra-
connective tissues. The Trabectome, in theory, offers advantages for bectome handpiece, currently cleared for single-use only, includes
a foot-pedal controlled gravity infusion sleeve (19 gauge) and an
adjustable aspiration function (25 gauge) (Fig. 1). Currently in-use
in the US, Mexico, Canada, and Japan, this device has promise as an
alternative to laser trabeculoplasty or filtering surgery in eyes with

Table 1
Combined AAO and Oxford system for rating peer reviewed literature (courtesy of
Ophthalmology).

AAO Oxford level Type of study

grade of
evidence
I 1a Systematic review (with homogeneity) of RCTs
1b Individual RCT (with narrow confidence interval)
1c All or none

II 2a Systematic review (with homogeneity) of cohort studies

2b Individual cohort study (including low quality RCT; e.g., <80%
follow-up)
2c ‘‘Outcomes’’ research
3a Systematic review (with homogeneity) of case–control studies
Fig. 2. Scanning electron micrograph from the angle of an autopsy eye after Tra- 3b Individual case–control study
bectome. No obvious mechanical damage to the posterior wall of Schlemm’s canal is
III 4 Case series (and poor quality cohort and case–control studies)
apparent and the ostea of a collector channel appears unharmed. The inset at higher
5 Expert opinion without explicit critical appraisal, or based on
magnification illustrates an intact cell along the posterior wall of Schlemm’s (SEM
physiology, bench research or ‘‘first principles’’
150; [inset SEM 450] courtesy Douglas Johnson, MD).
794 D.S. Minckler, R.A. Hill / Experimental Eye Research 88 (2009) 792–798

open-angle glaucoma not responding to medical therapy. IOP The mean decrease in adjunctive medications for Trabectome-
outcomes to date in an ongoing clinical case series of Trabectome- only cases was 39% from a preoperative mean of 2.9  1.30 to
only procedures have been in the mid-low teens so it may not be a mean postoperative utilization of 1.8  1.4 anti-glaucoma medi-
appropriate for eyes in which a very low IOP goal is deemed cations (Minckler et al., 2008) (Fig. 4B). Failure defined as additional
necessary. As with any new glaucoma surgery, patient selection glaucoma surgery (repeat Trabectome, trabeculectomy, aqueous
should take into account the expected IOP outcome. shunt, laser trabeculoplasty, cyclophotocoagulation) occurred in
The Trabectome is also being combined with cataract surgery as 100/738 (14%) of Trabectome-only cases. Twelve of 100 surgical
the glaucoma part of combined surgery (Francis et al., 2008; failures occurred by two weeks and 76/100 by 6 months (Minckler
Minckler et al., 2008). Follow-up data in combined Trabectome– et al., 2008).
phacoemulsification surgeries indicate an average sustained drop The relatively large clinical experience to date with published data
in IOP over two years postoperatively of approximately 5 mm, on over 1000 cases including follow-up out five-years in a very small
substantially more than reported in some studies after phacoe- number justifies the conclusion that short-term complications of this
mulsification alone (Francis et al., 2008; Minckler et al., 2008). procedure are few and generally not vision threatening. Admittedly,
Analyses of Trabectome IOP outcomes in a variety of subgroups to date Trabectome users have been largely confined to glaucoma-
have so far indicated relatively consistent mid-teen postoperative trained individuals highly experienced with gonioscopy who have
IOPs with the majority stable on fewer medications than preoper- had minimal difficulty mastering the skills required. Some obvious
atively after six months (Fig. 4A and B) (Minckler et al., 2008). hazards of this procedure include inadvertent intraoperative cyclo-
Preliminary unpublished analysis of IOP outcomes in eyes after dialysis, only two of which have been reported so far among over
prior failed trabeculectomy or laser trabeculoplasty (ALT or SLT) 1000 surgical records received by the company database. Obvious
suggests these prior procedures do not have negative effects on IOP other risks of Trabectome include iris, lens and corneal endothelial
outcomes (NeoMedix company data). The Trabectome experience injury, none of which have been reported since the original series in
to date has included a relatively large percentage of high risk-for- 1995 in which transient Decemet’s injuries were noted in 3/37 eyes
failure cases. Among 489 cases of Trabectome-only surgeries (Minckler et al., 2005). Intraoperative back-bleeding from Schlemm’s
summarized 8/23/08, 107/489 (22%) had prior trabeculectomy and canal and small transient postoperative hyphema remain frequent.
420/489 (86%) had undergone prior ALT or SLT. Visual field defects Persistent large hyphemas requiring washout have been rare. No
were ‘‘advanced’’ (involving 3 quadrants) among 173/489 (35%) reports of persisting hypotony, choroidal effusion or hemorrhage, or
(NeoMedix, unpublished data). endophthalmitis have been received from Trabectome users.
The decrease in IOP among Trabectome-only cases with or The Trabectome, in theory, offers advantages for angle surgery
without medications was 40% at 24 months (n ¼ 46), 41% at 36 in children or adults compared to traditional goniotomy or ab
months (n ¼ 35) and 35% at 60 months (n ¼ 2) to 16.4  4.5 mm Hg interno or ab externo trabeculotomy as it includes removal of a strip
down from a mean preoperative IOP of 25.7  7.7 mm Hg (Minckler of meshwork and aspiration of tissue debris (Figs. 1 and 2). Reflux
et al., 2008) (Fig. 4A). Kaplan–Meier plots defining ‘‘failure’’ as bleeding from Schlemm’s canal during surgery is common but
IOP > 21 and not reduced by 20% below baseline (on 2 consecutive transient and vision threatening complications have been minimal
visits) after 2 weeks and no repeat surgery for Trabectome-only (Francis et al., 2008; Minckler et al., 2008). To date, the Trabectome
cases (N ¼ 738) indicated ‘‘failure’’ at 24 months of approximately does not appear to accelerate cataract formation. Importantly it
35% (Fig. 3). Defining ‘‘failure’’ as IOP > 21 or not reduced by 20% does not preclude standard surgery subsequently as the conjunc-
below baseline (on 2 consecutive visits) after 3 months and no tiva is not traumatized.
repeat glaucoma surgery for the same group at the same time-point Trabectome was cleared by the FDA for use in open-angle
indicated a ‘‘failure’’ rate of about 55% (Minckler, et al., 2008). glaucoma in 2004. Clearances in Europe and Japan are pending.

Fig. 3. Survival curve (N ¼ 1127) of Trabectome-only and combined Trabectome–phacoemulsification cases (Francis et al., 2008) (by permission, Transactions of the American
Ophthalmological Society).
 D.S. Minckler, R.A. Hill / Experimental Eye Research 88 (2009) 792–798 795

Fig. 4. IOP (A) and adjunctive medications (B) after Trabectome-only (N ¼ 738) (Francis et al., 2008 (by permission, Transactions of the American Ophthalmological Society).

2. Glaukos iStentÔ (AAO/Oxford level III/4 evidence) iStent and phacoemulsification to phacoemulsification alone. No
data from this trial, mandated as part of the FDA clearance process,
The Glaukos iStent (Fig. 5) is currently being studied in a multi- have yet been reported in peer reviewed literature. The rationale
center randomized trial in the US comparing IOP outcomes after for the device is similar to that of Trabectome in that it provides
a channel for direct trans-trabecular aqueous outflow from anterior
chamber to collector channels. It is self-retaining and constructed
of implant grade titanium (6AL4V) and heparin coated (Duro-
flowÔ) (Fig. 5). It is angled on one side of its arch shaped body with
an inlet of 80 mm internal diameter on the other side. The applicator
(Fig. 6) tubing is 26 gauge from which extend 4 fingers securing the
device by the inlet tube. The applicator has been shown capable of
recovering the device should it be dropped into the anterior
chamber by one of the authors (RAH) during early clinical use. The
device is placed via gonioscopic control (Trabecular Bypass
Gonioprism; Ocular Instruments, Bellevue, WN) into Schlemm’s
canal (Fig. 7).
Peer reviewed published clinical outcomes to date with iStent
include only basic science studies and small clinical case series
(Spiegel and Kobuch, 2002). The initial clinical study (N ¼ 6)
utilizing a silicone trans-trabecular shunt placed via an ab
Fig. 5. Glaukos iStent trans-trabecular bypass stent (courtesy of Glaukos Corporation). externo approach demonstrated that the iStent could lower IOP
796 D.S. Minckler, R.A. Hill / Experimental Eye Research 88 (2009) 792–798

and stabilized at 14–15 mm Hg with reduced medications out to

one year. All devices remained in place and no complications were
noted.
An obvious concern about the iStent is accidental dislodgment
from the inserter into the anterior chamber. The inserter is designed
to permit retrieval of the device should it become loose from the
inserter or be dislodged from Schlemm’s canal. The mass of the
device is so small that it ‘‘floats’’ without descending in viscoelastic so
it seems unlikely that the device, if released into the anterior chamber
during insertion, would become lodged in the angle or fall through
the pupil. One of the authors (RAH) successfully retrieved and
implanted an iStent dropped by another surgeon during a demon-
stration surgery. No reports have been received of dislodgement of
iStent into the aqueous postoperatively. The iStent does not appear to
accelerate cataract. Only time and larger experience can provide an
estimate of these hazards. No data including complications or
surgical problems have yet been made available from ongoing trials.
Fig. 6. Glaukos iStent inserter (courtesy Glaukos Corporation). The iStent has been investigated alone and in combination with
cataract surgery in larger groups (Spiegel et al., 2008). De Feo et al.
(Spiegel et al., 2002). The device was successfully placed in four (ARVO 2008 poster A235) reported 45 patients who had iStent
of five eyes, with follow-up in those four to 5–9 months. The implantation alone. In their series IOP dropped from a mean preop-
stent was removed from one eye in which excessive bleeding erative level of 28.4  6.39 to 17.9  3.62 mm Hg at 18 months and
was thought to have occurred intra-operatively. Preoperative IOP medications decreased from 2.1  0.94 to 1.2  1.18. Transient iStent
(range 23.4–16.5 mm Hg) decreased in all four eyes on fewer lumen occlusion occurred in 7 eyes and malpositioning was reported
medications. Two eyes developed an external bleb. During all in 9 eyes.
postoperative visits from one day to one year, IOPs remained 14– Speigel et al. (ARVO 2008 poster A240) reported 48 patients,
15, down from a preoperative mean of 20.2  6.3 mm Hg (range including 41 with 18 months follow-up, who underwent combined
14–31). iStent and cataract surgery. IOP reduced from a baseline of
In cultured autopsy eye perfusion experiments in which Doug 21.9  3.98 to 16.9  3.24 mm Hg, a 21.4% drop (P < 0.0001).
Johnson participated, adding successive bypass shunts produced Medication use dropped from 1.7  0.9 to 0.5  0.74. Buznego and
step-wise increases in outflow. This in vitro experiment provided an Tratter (ISRS 2007 poster 101052) provided interim results on
enticing demonstration of the potential for achieving very low IOP a two-year study of iStent and cataract extraction. Forty-two
with such devices, not yet demonstrated in vivo (Ahou and Smedley, patients had completed 12 months of a 24-month study. IOP
2005). Although the first shunt had the most effect, dropping IOP dropped from 21.7  3.98 to 17.4  2.99 mm Hg at 12 months and
from 21.4  3.8 to 12.4  4.2 mm Hg, successive addition of up to four medications dropped from 1.6  0.8 to 0.4  0.62 mm Hg. Half the
stents placed into Schlemm’s canal produced step-wise reduction in subjects achieved an IOP  18 mm Hg and had discontinued all
system pressure (13.6  4.1 to 10.0  4.3 mm Hg). Complete removal topical medications by 12 months. The most commonly reported
of the meshwork lowered IOP to 6.3 G 3.2 mm Hg (Ahou and adverse event was stent lumen obstruction in 7 eyes. iStent mal-
Smedley, 2005). positioning without IOP failure was noted in 6 eyes.
A second small clinical case series (N ¼ 6) reaffirmed the Simmons et al. (American Glaucoma Society 2008, poster #72)
potential clinical utility of the current titanium version inserted ab reported a multi-center open-label study involving 45 eyes with
interno, and provided additional reassurance that the device stayed refractory POAG, all of whom had prior failed filtering surgeries.
in place and continued to function to lower IOP with fewer medi- Thirty of the 45 subjects had reached 18 months in a planned 24-
cations through follow-up of one year (Spiegel et al., 2007). All month study. Preoperative mean IOP of 28.4  6.39 reduced to
patients were seen day one, week one, and at 1, 2, 6, and 12 months 17.9  3.62 mm Hg at month 18 (P < 0.0001). 90% of the 30 eyes still
postoperatively. The mean preoperative IOP of 20.2  6.3 decreased in the study at 18 months had IOPs  21 mm Hg. Ten eyes (33%)
achieved IOPs  21 on no medications. The most common adverse
event was trabeculectomy (safety exit) in 13 eyes.
These studies have been encouraging with regard to decreased
medication requirements postoperatively and decrease in IOP to an
average of approximately 17 mm Hg after iStent installation.
Complications have been infrequent so far in reported clinical
studies and minor in comparison to trabeculectomy with the most
frequent being iStent malpositioning presumed to lead to clinical
failure. Malpositioning however has not always correlated with
clinical failure. Reflux bleeding from Schlemm’s canal after visco-
elastic removal intra-operatively has been common.
The Glaukos iStent is CE marked for use in Europe. US FDA
clearance is pending.

3. iScience (canaloplasty) (supporting evidence level III/4)

This new procedure, currently in trial in Germany and the US in

adults, has evolved as a modification of viscocanalostomy with the
Fig. 7. Glaukos iStent in place in Schlemm’s (courtesy of Glaukos Corporation). initial peer reviewed publication in 2007 (Lewis et al., 2007).
 D.S. Minckler, R.A. Hill / Experimental Eye Research 88 (2009) 792–798 797

Schlemm’s canal is identified beneath the deeper of a two-layered 5. Discussion and summary
trabeculectomy-like scleral flap and a light bearing microcatheter
(iTrack & iLumen; iScience Interventional, Menlo Park, CA) threa- The new technologies discussed in this brief review all have
ded around the circumference of Schlemm’s canal while injecting promise but to date are supported only by low level evidence-
viscoelastic (4–6 mg Healon GV) exiting opposite the entrance site. based literature and advocate-comments during presentations at
A 10-O prolene suture is fixed to the end of the microcatheter and clinical meetings. None of them are intended to result in external
pulled around in the reverse direction, then tensioned, knotted, and bleb formation but inadvertent trabeculectomy-like blebs may
left in place within the canal tenting it inward. High resolution complicate canaloplasty (Lewis et al., 2007). To date all these
ultrasound available from the same company (iUltrasound) has procedures are reported to have lower complication rates than
demonstrated variable inward tenting of the canal lumen (graded trabeculectomy. Remarkably all have similar IOP outcomes usually
0–3) and was thought to correlate with IOP outcomes among in the mid-teens. The traditional assumption has been that epis-
canaloplasty-only eyes, those with more trabecular distention cleral venous pressure (G8 mm Hg) accounts for the lower limit of
having statistically significantly more IOP lowering (Lewis et al., IOP achievable by eliminating the resistance of the meshwork–
2007). Combined canaloplasty and phacoemulsification was per- juxtacanalicular complex, which is what Trabectome and iStent
formed in 27/94 eyes (29%). attempt to achieve directly. iScience canaloplasty has a less clear
Difficulties during this initial case series included inability to rationale but its potential efficacy for lowering IOP has been
achieve a 360 cannulation of Schlemm’s in 11/94 eyes (12%), reinforced in the initial report (Lewis et al., 2007). Presumably
inability to place a tensioning suture in 20/94 eyes (21%), inadver- trans-trabecular flow is enhanced with canaloplasty by tensioning
tent bleb formation in 18/94 (19%) and intraoperative conversion to the meshwork with the indwelling suture in Schlemm’s canal. The
trabeculectomy in 4 eyes (4%) (Lewis et al., 2007). A mean IOP of Solx device, a suprachoroidal trans-limbal shunt, has intriguing
15.3  3.8 mm Hg was achieved among the 74 (Group B) eyes with features, especially the potential for postoperative upward
successful 360 catheterization and tensioning at 12 months adjustments in outflow via non-invasive laser applications through
follow-up. Complications included hyphema and elevated IOP the cornea and anterior chamber. However, historically, supra-
postoperatively, but were generally minimal and resolved by 2 choroidal shunts including a variety of non-lumened setons con-
months after surgery (Lewis et al., 2007). structed of a variety of materials have not been successful most
likely because the posterior portion is eventually walled-off by
4. SolxÒ suprachoroidal shunt (supporting evidence fibrous tissue relatively impermeable to aqueous through-flow
level III/5) (Minckler, 1997). A key feature of currently successful aqueous
shunts, otherwise ignored in this review, is their inclusion of
The Solx gold shunt (Solx Inc; http://www.solx.com/solx_ a large equatorial explant plate that ensures bleb formation
goldShunt.htm) is currently being studied in a multi-center trial (Minckler, et al., 2008 OTA).
comparing Ahmed aqueous shunts to Solx in refractory adult Since IOP outcomes with all of these new approaches are usually
glaucomas. No trial data has yet been published. The rationale for in the mid-teens, it seems obvious that simply opening Schlemm’s
this device, supported by an initial company-sponsored pilot canal (Trabectome) or bypassing Schlemm’s (iStent), or enhancing
study, is that aqueous can be drained into the suprachoroidal trans-trabecular flow (canaloplasty), or allowing trans-limbal
space. Besides being constructed of gold, the design includes aqueous drainage from the anterior chamber into the supra-
several channels through its body besides those initially choroidal space (Solx) provides limited reduction (normalization)
functioning that potentially can be successively opened after of IOP. Based on available clinical data, the very low IOPs considered
installation via a laser applied to windows in its anterior chamber necessary in many patients with open-angle glaucoma will not be
component. The anterior end of this 24-karat device with achieved by any of these methods. Although normalization of IOP
dimensions of 5.2 mm length, 3.2 mm width and 44–68 mm may be adequate for eyes in the early or mid-phases of optic nerve
thickness is placed into the anterior chamber over the scleral injury in many cases, traditional filtering surgery with anti-fibrotic
spur via a scleral incision and the posterior end positioned in the enhancement and bleb formation will probably remain the prin-
suprachoroidal space. Bleb formation is not expected. The cipal surgical approach to eyes with advanced glaucomatous optic
potential for in vivo postoperative adjustments in outflow via neuropathy. Assuming ongoing clinical studies continue to be
laser offers hope of titrating outflow upward over time to favorable, a strong argument for application of Trabectome and
compensate for possible decrease in outflow with time. The flow- iStent, minimally invasive procedures which do not lead to bleb
resistance is stated to be 0.65–1.3 mm Hg/ml/min. Initial clinical formation nor require anti-fibrotics, early in the glaucoma injury
results (pilot study) available on the website demonstrate process can be made, especially considering the relatively transient
favorable IOP outcomes, with IOP drop from a mean of 27.1 benefits of laser trabeculoplasty and the difficulties of compliance
(n ¼ 59) to a mean of 18.9 mm Hg at 52 weeks (n ¼ 47). with medical therapy. Very much in their favor, neither of these
This device could be viewed as a ‘‘controlled’’ cyclodialysis, procedures damages the conjunctiva superiorly. Solx, while
a procedure long abandoned as an elective glaucoma surgery due to somewhat more invasive than Trabectome and iStent, appears
its unpredictable effect on IOP often including hypotony. Also, based technically simpler than any of the other procedures discussed
on failure of previous suprachoroidal stents, rods, wires, and sutures here. Canaloplasty, arguably the most technically demanding of
composed of various materials, and lumened tubes without these four procedures, is unlikely to result in bleb formation but
a posterior plate component, skepticism that this device will func- obviously compromises subsequent standard filtering surgery
tion long-term is justified in spite of favorable initial study results on options if done superiorly.
the company’s website. It seems highly likely that the posterior flow The consistent mid-teen IOPs achieved with these new proce-
of aqueous will be constrained or blocked by fibrous encapsulation dures remind us that we lack understanding of the intra-scleral
of the device’s body in the suprachoroidal space. Again, time and outflow physiology that limits the level of IOP achievable. One
increased clinical experience will clarify the real potential of this recent attempt at computer modeling of this process has been
new drainage device (Minckler, 1997). published (Zhou and Smedley 2006). While postoperative tissue
Solx is CE marked for use in Europe. US clearance is expected reactions including fibrosis may close the Trabectome cleft or cap
in 2009. the orifices of the iStent, follow-up data so far have been
798 D.S. Minckler, R.A. Hill / Experimental Eye Research 88 (2009) 792–798

encouraging as to the durability of benefits of both approaches. Minckler, D., 1999. Study design scheme, structured abstract sections and study
design worksheets (appendix to instructions for authors; page 185). Ophthal-
With regard to correlating IOP outcomes with the arc of angle
mology 106, 185–206.
treated by the Trabectome, a preliminary report utilizing gonio- Minckler, D.S., Baerveldt, G., Alfaro, M.R., Francis, B.A., 2005. Clinical results with the
photography documentation found only a weak correlation Trabectome for treatment of open-angle glaucoma. Ophthalmology 112,
between the length of the treatment and IOP outcomes (Khaja, H.A., 962–967.
Minckler, D.S., Baerveldt, George, Ramirez, Marina Alfaro, Mosaed, Sameh,
Hodge, D.O., Sit, A., ARVO 2008, poster # 4191). With either Tra- Wilson, Richard, Shaarawy, Tarek, Dustin, Laurie, Francis, Brian, 2006. Clinical
bectome or iStent, the key issues determining duration of benefit results with the Trabectome, a novel surgical device for treatment of adult
may turn out to be persistence of the opening (cleft or iStent open-angle glaucoma. Trans. Am. Ophthalmol. Soc. VIV (V), 104.
Minckler, D.S., Mosaed, S., Dustin, L., Francis, B.A.; The Trabectome Study Group,
opening) and proximity to collector channels. Canaloplasty and 2008. TrabectomeÒ (trabeculectomy-internal approach) additional experience
Solx trial results will hopefully be forthcoming in the near future. and extended follow-up. Trans. Am. Ophthalmol. Soc. 106, 1–12.
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Smith, S.C., Singh, K., 2008. Aqueous shunts in Glaucoma. Ophthalmic Tech-
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