Graefe's Archive for Clinical and Experimental Ophthalmology

https://doi.org/10.1007/s00417-018-4023-8

GLAUCOMA

Trabectome outcomes across the spectrum of glaucoma disease severity

Sarah Farukhi Ahmed 1,2 & Anand Bhatt 1,2 & Mason Schmutz 1,2 & Sameh Mosaed 1,2

Received: 13 December 2017 / Revised: 1 April 2018 / Accepted: 23 May 2018

# Springer-Verlag GmbH Germany, part of Springer Nature 2018

Abstract
Purpose To compare the efficacy of ab-interno trabeculotomy with Trabectome® in mild glaucoma versus moderate/severe
glaucoma along the spectrum of glaucoma disease severity.
Methods Subjects with at least 12 months follow-up were separated into two groups based on glaucoma severity. Severity was
determined based on optic nerve cup-to-disc ratio and/or automated visual field data, with cup-to-disc ratio < 0.7 and/or visual
field mean deviation ≤ 6.0 dB used to define the mild group (n = 1127), and cup-to-disc ratio > 0.7 and/or visual field mean
deviation > 6.0 dB used to define the moderate/severe group (n = 1071). These groups were further subdivided into patients
undergoing Trabectome with cataract surgery or Trabectome alone. Mean IOP reduction, medication usage, and success rates
were compared between the two groups. Success was defined as IOP reduction of 20% or more from pre-operative IOP and IOP
less than 21 mmHg with no secondary surgery throughout the follow-up period.
Results The mean post-operative IOP and success rates were similar between the groups. IOP reduction for the mild group was
26% (from pre-op IOP of 24 to 16.1 mmHg) and for the moderate/severe group was 24% (from pre-op IOP of 22.6 to
15.7 mmHg) at 12 Months. The overall rate of success at 12 months for the mild group was 86% and for the moderate/severe
group was 83%.
Conclusion Trabectome surgery maintains efficacy across the spectrum of glaucoma disease severity. This particular minimally
invasive glaucoma surgery procedure can be an excellent choice for subjects with moderate/advanced glaucoma as well as for
early glaucoma with or without cataract surgery and is applicable to a broad patient population.

Keywords Trabectome . Glaucoma disease . Cataract . MIGS procedure . IOP

Introduction external filtration, achieves guarded external filtration

Currently, there are a plethora of medical and surgical options
in the management of open-angle glaucoma (OAG). Surgical
treatment is typically considered after failure to achieve intra-
ocular pressure (IOP) control with maximum tolerated medi-
cal therapy [1].
Conventional glaucoma surgery is based on the concept of
fistulization, which involves creating an external pathway for
outflow from the anterior chamber to the subconjunctival
space. Trabeculectomy, one of the traditional methods of
* Sarah Farukhi Ahmed
sfarukhi@gmail.com
1 gery is different from external filtration procedures as it seeks
Gavin Herbert Eye Institute, University of California-Irvine, 850
Health Sciences Road, Irvine, CA 92697-4375, USA
2 eye rather than creating a new drainage pathway through
Irvine School of Medicine, University of California,
Irvine, CA 92697, USA
by creating a fistula from the anterior chamber to the
subconjunctival space creating a filtering bleb. Another
traditional external filtration procedure, glaucoma drainage
implants, provides a route for aqueous egress from the anterior
chamber to a subconjunctival and subtenon’s capsule formed
surrounding the filtering device. Though both techniques have
had success in lowering IOP, the presence of an external bleb
significantly increases the risk of both short-term and long-
term post-operative complications. These include decreased
vision, diplopia, blebitis, hypotony, leaks, and endophthalmi-
tis to name a few [1].
A more modern approach to the surgical treatment of glau-
coma began in 2004 with the introduction of
Trabectome (Neomedix Corp, Tustin CA), the first micro
incisional glaucoma surgery. Micro incisional glaucoma sur-
to enhance outflow through the natural drainage system of the
fistulization. In avoiding an external filtration surgery, bleb-

related complications and the rate of post-operative hypotony
are reduced and post-operative recovery is hastened. Since
the introduction of the first variety of micro incisional
glaucoma surgery in 2004, this category of surgery has
become much more frequently used as an alternative to
trabeculectomy and glaucoma drainage implants.
Investigators have previously supported the use of micro
incisional glaucoma surgery as an effective treatment in mild
varieties of open-angle glaucoma [2–6]. The use of micro
incisional glaucoma surgery in patients with moderate or ad-
vanced open-angle glaucoma has not been well studied.
The Trabectome device utilizes a handpiece providing irri-
gation, aspiration, and electrocautery plasma ablation. The
handpiece is inserted into the anterior chamber through a tem-
poral clear corneal incision, and under gonioscopic visualiza-
tion, the needle tip is used to pierce the trabecular meshwork
and then advanced circumferentially while applying electro-
cautery energy to ablate the trabecular meshwork and inner
wall of Schlemm’s canal. Approximately 90–180° of the
drainage tract is typically ablated. This ablation creates a cleft
unifying the anterior chamber with the Schlemm’s canal and
allows aqueous to more directly access collector channels
without the resistance of the trabecular meshwork. This tech-
nique is unique as it has been approved for use in the USA
with and without concurrent cataract surgery, across the spec-
trum of disease severity, in pediatric and adult populations,
and has the longest term follow-up of any of the current micro
incisional glaucoma techniques.
Prior studies have shown the wide application of
Trabectome in various types of OAG [1, 2]. Historically, mi-
cro incisional glaucoma surgeries were thought to be best
suited for mild glaucoma, and indeed the other micro
incisional glaucoma implants currently approved by the
FDA are indicated for use only in mild-moderate disease,
and only in combination with cataract extraction [3, 4, 6, 7].
In this study, we specifically compare Trabectome outcomes
in patients with mild OAG versus moderate/severe OAG.
Materials and methods
This was a prospective outcome analysis of patients grouped
by OAG severity undergoing Trabectome with cataract sur-
gery or Trabectome alone. The data was obtained from the
Multinational Trabectome Study Group Database from May
2003 to present. Data for this report has been collected with
Institutional Review Board (IRB) approval and in accordance
with the Declaration of Helsinki and the Health Insurance
Portability and Accountability Act. The informed consent
was waived by Approved IRB per 45 CFR 46.116 (d).
The Trabectome Study Group is a multinational database
that consists of pre-operative, intra-operative, and post-
operative patient data related to Trabectome Surgery [8]. The
Graefes Arch Clin Exp Ophthalmol
IRB-approved protocol related to this database allows sur-
geons to prospectively collect and report 1-year follow-up
data on their initial 20 Trabectome cases and includes spe-
cifics such as patient demographics, baseline statistics, and
intra-operative and postoperative complications. The
Trabectome Study Group has contributed to numerous prior
publications [1–7, 9, 10].
Utilizing this dataset, patients were classified into two
groups: mild OAG versus moderate/severe OAG according
to a modified version of the Hodapp, Parish, and Anderson
(HPA) classification scheme. The HPA classification is a clin-
ically relevant scheme that considers both mean deviation
(MD) and the number of defective points on Humphrey visual
field [13]. Mild glaucoma is defined as MD less than 6 dB and
less than 10 depressed points on the pattern deviation plot.
Moderate glaucoma is classified as MD less than
12 dB and less than 20 points of depression on pattern
deviation. And, severe glaucoma was defined as MD
greater than 12 dB and greater than 20 points of depression
on pattern deviation.
Since the data provided by the Trabectome Study
Group did not consistently include pattern deviation on
visual fields, only the mean deviation was used in our
modified classification scheme (Table 1). Severity was
determined based on optic nerve cup-to-disc ratio and/or
automated visual field data, with cup-to-disc ratio < 0.7
and/or visual field mean deviation ≤ 6.0 dB used to define the
mild group (n = 1127), and cup-to-disc ratio > 0.7 and/or vi-
sual field mean deviation > 6.0 dB used to define the
moderate/severe group (n = 1071). Similar modified classifi-
cation schemes have been used in previous studies as well
[11–13].
All patients in this study were classified as open-
angle glaucoma (OAG) through the Shaffer classifica-
tion scheme (grade 3 or above) by board certified oph-
thalmologists. Data analysis included baseline pre-
operative IOP, glaucoma medication usage, and visual field
mean deviation, with a minimum of 1-year follow-up post-
operatively. All patients with less than 1 year follow-up and
non-open-angle varieties of glaucoma were excluded from
this study.
Pre-operative and post-operative outcomes were compared
with the two-sample Wilcoxon test between different types of
Table 1 Severity classification scheme. Patients were separated into two
groups: mild open-angle glaucoma (OAG) versus moderate/severe OAG
Number of Mean Optic nerve
patients/ deviation cup-to-disc
group (n) (dB) ratio (CDR)
Mild OAG 1127 ≤ 6.00 ≤ 0.7
Moderate/severe OAG 1071 > 6.00 > 0.7
Graefes Arch Clin Exp Ophthalmol

OAG. Kaplan-Meier survival curves and log-rank tests were Results

used to compare survival rates of the two groups. A two-
proportion Z-test was used to compare secondary surgery rate
of mild versus moderate/severe group. Excel software
(Microsoft Word Corp.) and R 2.14.0 were utilized for the
data compilation and statistical analysis.
Applying the same success criteria established by the
Tube versus Trabeculectomy (TVT) publications, suc-
cess was defined as IOP less than 21 mmHg, and IOP
reduction of 20% magnitude from baseline after 1 year
post-operatively on two consecutive visits [13]. In addi-
tion, any secondary glaucoma surgery was considered
treatment failure.
After applying the inclusion criteria, a total 2198 cases were
analyzed. One thousand one hundred twenty-seven patients
were classified as having mild glaucoma underwent
Trabectome of which 450 (40%) underwent concurrent cata-
ract surgery. One thousand seventy-one patients were classi-
fied as having moderate or severe glaucoma underwent
Trabectome of which 392 (37%) underwent concurrent cata-
ract surgery. The demographic comparison between the two
groups is summarized in Table 2. The demographic differ-
ences between the groups such as age and gender were not
statistically significant.

Table 2 Demographics. This

table demonstrates the Group 1 Group 2
demographic comparative Mild glaucoma Moderate/severe glaucoma
analysis of both subgroups mild N = 1127 N = 1071
glaucoma versus moderate/severe
glaucoma. The difference Age
between the two groups were not
statistically significant Mean ± SD 70 ± 14 69 ± 14
Range (6 to 96) (0 to 96)
Gender
Female 560 (50%) 568 (53%)
Male 523 (46%) 462 (43%)
NR 44 (4%) 41 (4%)
Glaucoma diagnosis
Primary open-angle glaucoma (POAG) 779 (69%) 779 (73%)
Pseudoexfoliation glaucoma 121 (11%) 123 (11%)
Juvenile glaucoma 3 (0%) 16 (1%)
Steroid-induced glaucoma 20 (2%) 9 (1%)
Pigment dispersion 41 (4%) 26 (2%)
Uveitic glaucoma 27 (2%) 19 (2%)
Ocular hypertension 7 (1%) 0 (0%)
Normal-tension glaucoma 17 (2%) 18 (2%)
Traumatic glaucoma 4 (0%) 3 (0%)
Secondary glaucoma 32 (3%) 39 (4%)
Other glaucomas 76 (6%) 39 (4%)
Visual field
Mild 280 (25%) 131 (12%)
Moderate/advanced 310 (27%) 667 (63%)
MD/other 537 (48%) 273 (25%)
Lens status
Phakic 757 (67%) 702 (66%)
Pseudophakic 301 (27%) 314 (29%)
Aphakic 9 (1%) 7 (1%)
NR 60 (5%) 48 (4%)
Prior surgeries
SLT 82 (7%) 117 (11%)
ALT 218 (19%) 269 (25%)
Glaucoma drainage device 0 (0%) 24 (2%)
Trabeculectomy 0 (0%) 118 (11%)
 Graefes Arch Clin Exp Ophthalmol

Overall, in the mild OAG group including Trabectome
alone and Trabectome combined with phacoemulsificiation,
pre-operative IOP was 24.0 ± 7.9 mmHg (n = 1127). At
12 months follow-up after Trabectome, IOP was reduced on
average by 26.4% to 16.1 ± 4.0 mmHg (Table 3). The average
success rate at 1 year post-operatively in mild OAG was 86%
(Fig. 1).
In patients with mild glaucoma undergoing trabectome
alone (n = 670) at 1 year follow-up, an average pre-operative
IOP of 25.3 ± 8.3 mmHg was reduced to an average of 16.2 ±
4.2 mmHg (Table 4). This was a reduction in IOP on average
of 28.6% from baseline. Kaplan-Meier analysis showed a 1-
year success rate of 83% (Fig. 2).
In patients with mild glaucoma, at 1 year follow-up after
Trabectome with cataract surgery (n = 457), an average pre-
operative IOP of 21.9 ± 6.6 mmHg was reduced to an average
of 15.8 ± 3.8 mmHg (Table 5). This was a reduction in IOP on
average of 23.4% from baseline at 1 year post-operatively.
Kaplan-Meier analysis showed a 1-year success rate of 92%
(Fig. 2).
The mean pre-operative IOP in the moderate/severe group
was 22.6 ± 7.4 mmHg (n = 1071). At 12 months follow-up,
the average IOP was reduced on average 23.9% to 15.7 ±
4.4 mmHg (Table 3). Secondary surgery, IOP, and the number
of glaucoma medications at 3, 6, and 12 months for
Trabectome and combined Trabectome and cataract surgery
are presented on Tables 4 and 5, respectively. The average
group success rate at 1 year was 83% (Fig. 1). The difference
between Trabectome (overall) mild group compared to
Trabectome (overall) severe group was not statistically signif-
icant (p = 0.06).
In patients with moderate/severe glaucoma, at 1 year fol-
low-up after Trabectome alone (n = 668), an average
pre-operative IOP of 23.9 ± 7.3 mmHg was reduced to
an average of 16.3 ± 4.3 mmHg (Table 4). This was a
reduction in IOP on average of 25.8% from baseline.
Kaplan-Meier analysis showed a 1-year success rate of
77% (Fig. 2).
In patients with moderate/severe glaucoma, at 1 year
follow-up after Trabectome with cataract surgery (n = 403),
an average pre-operative IOP of 20.3 ± 6.8 mmHg was re-
duced to an average of 14.8 ± 3.3 mmHg (Table 5). This was
a reduction in IOP on average of 21.2% from baseline.
Kaplan-Meier analysis showed a 1-year success rate of 93%
(Fig. 2).
While both groups required an average of 2.0 ± 1.4 IOP-
lowering medications to sustain IOP at goal, this was a signif-
icant reduction from baseline (p < 0.01, Table 3). In patients
undergoing Trabectome with mild glaucoma, medication de-
pendence was reduced on average by 14.4% at 12 months

Table 3 IOP, number of glaucoma medication, and secondary surgery in mild and moderate/severe glaucoma groups undergoing Trabectome (overall
results with or without cataract surgery)

Group 1 Group 2 p value (comparison

Mild glaucoma Moderate/severe glaucoma between groups)
(n = 1127) (n = 1071)

Mean ± SD Absolute reduction Mean ± SD Absolute reduction Absolute reduction (%)

(%) (%)

IOP (mmHg)
Baseline 24.0 ± 7.9 22.6 ± 7.4
3 months 16.1 ± 4.8 − 7.8 ± 7.6 (− 27.9%) 15.7 ± 4.4 − 6.9 ± 7.5 (− 25.4%) < 0.01*(<0.01*)
6 months 16.1 ± 4.2 − 7.5 ± 7.5 (− 26.7%) 15.7 ± 4.0 − 6.6 ± 7.2 (− 24.4%) < 0.01*(0.01*)
12 months 16.1 ± 4.0 − 7.4 ± 7.4 (− 26.4%) 15.7 ± 4.0 − 6.5 ± 7.1 (− 23.9%) < 0.01*(0.01*)
Medications (no.)
Baseline 2.6 ± 1.4 2.8 ± 1.2
3 months 2.1 ± 1.4 − 0.4 ± 1.2 (− 7.9%) 2.3 ± 1.4 − 0.5 ± 1.3 (− 10.5%) 0.47 (0.61)
6 months 2.0 ± 1.4 − 0.6 ± 1.2 (− 14.1%) 2.1 ± 1.4 − 0.6 ± 1.3 (− 15.1%) 0.49 (0.99)
12 months 1.9 ± 1.4 − 0.6 ± 1.3 (− 14.4%) 2.1 ± 1.4 − 0.6 ± 1.3 (− 14.6%) 0.67 (0.70)
Secondary surgery
Baseline 0 0
3 months 16 (1%) 17 (2%) 0.75
6 months 38 (3%) 50 (5%) 0.12
12 months 88 (8%) 116 (11%) 0.01*

Mean IOP and number of Medication for Patients. Wilcoxon test were conducted on comparing baseline IOP or Number of Medications. Significance
level is 0.05
*Statistically significant
Graefes Arch Clin Exp Ophthalmol

Fig. 1 Success rate overall of Trabectome in mild and moderate/severe
glaucoma. Success was defined as IOP reduction of 20% or more from
pre-operative IOP and IOP less than 21 mmHg with no secondary surgery
throughout the follow-up period. The graph demonstrates success rates
from 0 to 12 months after Trabectome surgery for both Trabectome stand-
alone and Trabectome with phacoemulsification. Kaplan-Meier analysis
showed a one- year success rate of 83% in the mild group and 86% in the
moderate/severe group. Log-rank test, comparing mild versus moderate-
severe groups above showed a p value 0.06

from 2.6 ± 1.4 medication bottles to 1.9 ± 1.4 medication bot- average 14.6% from 2.8 ± 1.2 medication bottles baseline to
tles at 12 months follow-up (Table 3). In patients with 2.1 ± 1.4 medication bottles at 1 year follow-up. Table 3 dem-
moderate/severe glaucoma, medications were reduced on onstrates the course of medication usage in both groups.

Table 4 IOP, number of glaucoma medication, and secondary surgery for mild and moderate/severe glaucoma patients undergoing Trabectome surgery
alone

Group 1 Group 2 p value (comparison

Mild glaucoma Moderate/severe glaucoma between groups)
(n = 670) (n = 668)

Mean ± SD Absolute reduction (%) Mean ± SD Absolute reduction (%) Absolute reduction (%)

IOP (mmHg)
Baseline 25.3 ± 8.3 23.9 ± 7.3
3 months 16.7 ± 5.4 − 8.6 ± 8.2 (− 29.0%) 16.4 ± 4.6 − 7.6 ± 7.9 (− 26.9%) 0.01*(0.06)
6 months 16.6 ± 4.5 − 8.4 ± 8.1 (− 28.0%) 16.4 ± 4.1 − 7.4 ± 7.4 (− 26.3%) 0.02*(0.04*)
12 months 16.2 ± 4.2 − 8.4 ± 7.9 (− 28.6%) 16.3 ± 4.3 − 7.2 ± 7.4 (− 25.8%) < 0.01*(0.02*)
Medications (no.)
Baseline 2.8 ± 1.3 3.0 ± 1.3
3 months 2.3 ± 1.4 − 0.5 ± 1.2 (− 10.2%) 2.4 ± 1.4 − 0.5 ± 1.4 (− 9.6%) 0.78 (0.65)
6 months 2.2 ± 1.4 − 0.6 ± 1.2 (− 15.0%) 2.3 ± 1.4 − 0.6 ± 1.3 (− 14.1%) 0.93 (0.79)
12 months 2.2 ± 1.4 − 0.6 ± 1.3 (− 12.4%) 2.3 ± 1.4 − 0.6 ± 1.4 (− 13.2%) 0.94 (0.77)
Secondary surgery
Baseline 0 0
3 months 14 (2%) 14 (2%) 0.99
6 months 32 (5%) 44 (7%) 0.15
12 months 77 (11%) 102 (15%) 0.04*

Mean IOP and the number of medication for patients performed with Trabectome Only. Wilcoxon tests were conducted on comparing baseline IOP or the
number of medications. Significance level is 0.05
*Statistically significant (p < 0.05)
 Graefes Arch Clin Exp Ophthalmol

Fig. 2 Success rate at 12 months following Trabectome in mild versus
moderate/severe glaucoma for Trabectome (alone) and combined
Trabectome with cataract surgery subgroups. A comparison between
patients undergoing Trabectome alone versus Trabectome with
phacoemulsification in both mild versus moderate/severe glaucoma
subgroups. The success rates in combined phacoemulsification and
trabectome were higher in both groups. In both the mild and moderate/
severe groups, the difference between Trabectome alone (TA) versus
Trabectome + Phaco (TP) was significant (p < 0.01)

The Trabectome outcomes (IOP and glaucoma medication Fig. 3. One hundred eighty-six patients were in other sub-
reductions) based on glaucoma subtypes are summarized in groups that are not presented in Fig. 3.

Table 5 IOP, number of glaucoma medication, and secondary surgery for mild glaucoma and moderate/severe glaucoma patients undergoing
combined Trabectome with cataract surgery

Group 1 Group 2 p value (comparison

Mild glaucoma Moderate/severe glaucoma between groups)
(n = 457) (n = 403)

Mean ± SD Absolute reduction (%) Mean ± SD Absolute reduction (%) Absolute reduction (%)

IOP (mmHg)
Baseline 21.9 ± 6.6 20.3 ± 6.8
3 months 15.2 ± 3.7 − 6.7 ± 6.5 (− 26.3% ± 22.3) 14.7 ± 3.8 − 5.6 ± 6.5 (− 23.0%) < 0.01*(0.02*)
6 months 15.5 ± 3.7 − 6.3 ± 6.5 (− 24.8%) 14.8 ± 3.5 − 5.4 ± 6.6 (− 21.6%) 0.02*(0.07)
12 months 15.8 ± 3.8 − 6.0 ± 6.4 (− 23.4%) 14.8 ± 3.3 − 5.3 ± 6.4 (− 21.2%) 0.08 (0.2)
Medications (no.)
Baseline 2.1 ± 1.3 2.5 ± 1.1
3 months 1.8 ± 1.4 − 0.3 ± 1.2 (− 4.5%) 2.0 ± 1.4 − 0.4 ± 1.3 (− 12.1%) 0.15 (0.20)
6 months 1.7 ± 1.3 − 0.5 ± 1.2 (− 13.0%) 1.9 ± 1.3 − 0.6 ± 1.3 (− 16.6%) 0.36 (0.76)
12 months 1.6 ± 1.3 − 0.5 ± 1.2 (− 17.1%) 1.8 ± 1.3 − 0.6 ± 1.3 (− 16.7%) 0.61 (0.74)
Secondary surgery
Baseline 0 0
3 months 2 (0%) 3 (1%) 0.55
6 months 6 (1%) 6 (1%) 0.83
12 months 11 (2%) 14 (3%) 0.35

Mean IOP and the number of medication for patients performed with Trabectome + Phaco. Wilcoxon tests were conducted on comparing baseline IOP or
the number of medications. Significance level is 0.05
*Statistically significant (p < 0.05)
Graefes Arch Clin Exp Ophthalmol
Fig. 3 IOP and glaucoma
medication usage from baseline
(%) in the overall data set (n =
1994). A comparison of the
percent reduction of medication
dependence and intraocular
pressure (IOP) between patients
of different glaucoma subtypes
over the course of 12 months after
Trabectome surgery
Discussion
In this prospective comparative analysis of ab-interno
trabeculectomy, we compare the success of Trabectome in
patients with mild OAG versus moderate/severe OAG.
Furthermore, we analyze the difference in success in each
group with or without concurrent cataract surgery. All groups
attained clinically significant IOP reduction and decreased
medication dependence after 1 year.
Though the Trabectome Study Group database contained
many different subtypes of open-angle glaucoma shown in
Fig. 3, our study primarily focuses on primary open angle.
Primary open-angle glaucoma is a disease in which the
juxtacanalicular trabecular meshwork (TM) is considered the
primary site of resistance to aqueous outflow. Histologically,
the TM of patients with primary open-angle glaucoma
(POAG) develops an increased thickness in the sheath of elas-
tic fibers compared to age-matched control patients [15, 16].
Cross-sectional analysis of these fibers reveals extracellular
plaques that have been termed Bsheath derived plaques^ [14,
15]. These plaques build up in the juxtracanalicular TM and
inhibit the flow of aqueous into Schlemm’s canal.
Trabectome ablation of the TM and inner Schlemm’s canal
removes this primary site of resistance, allowing for a more
direct drainage of aqueous into the episcleral venous system.
The resulting IOP reduction is dependent on the patient’s in-
herent episcleral venous pressure (EVP), which normally
ranges from 10 to 12 mmHg [11]. Therefore, physiologically
the IOP is not reduced below the EVP. This is unlike conven-
tional filtration methods which are able to achieve IOP below
the EVP.
Nonetheless, the reduction of IOP with Trabectome across
disease severity was clinically significant. While both groups
independently had a clinically significant IOP reduction, the
mild OAG percent reduction (26.4%) was greater than the
moderate/severe OAG (23.9%), (p < 0.01, Table 3). In the
Trabectome stand-alone group, the average percent reduction
of IOP between both groups followed a similar pattern, in
which mild OAG patients had a greater IOP reduction than
moderate/severe OAG patients (p < 0.01, Table 4). In both
scenarios, while the difference was found to be statistically
significant, the numerical difference in the final IOP between
mild versus moderate/severe OAG was less than 1 mmHg,
which is not clinically significant. Within the combined cata-
ract and Trabectome group, the IOP reduction difference be-
tween mild OAG and moderate/severe OAG was not statisti-
cally significant (p = 0.08, Table 5).
In our Kaplan-Meyer analysis, we see a clinically signifi-
cant higher success rate in the combined Trabectome and
phacoemulsification group in both mild and moderate/severe
glaucoma stages (Fig. 2, p < 0.01). This rate of success at
1 year post-operatively approaches the reported success of
glaucoma implant or trabeculectomy surgery at 1 year
follow-up [13].
Though cataract surgery can independently reduce IOP, pri-
or reports have shown the significant additional IOP reduction
contribution of the Trabectome procedure [6, 7]. A compara-
tive analysis of phacoemulsification (PCE) alone compared to
combined Trabectome and phacoemulsification was recently
performed by Francis et al. [6]. The study demonstrated that
combined Trabectome and PCE surgery reduced IOP 27% at
1-year post-operatively, compared to a 5% reduction with PCE
alone [6]. The most common post-operative complications
with Trabectome included post-operative hyphema and 1 day
post-operative IOP elevation. This IOP spike was reduced with
the use of pilocarpine for 1–2 months post-operatively to allow
for TM stretching and to prevent scarring [3].
Some factors may explain the lower rate of success of
Trabectome as a stand-alone procedure in this analysis across
the spectrum of disease severity. The lesser rate of success in
patients undergoing Trabectome alone may be influenced by
pre-operative patient selection bias. For instance, patients un-
dergoing the procedure as a stand-alone intervention may
have been more likely to have lower IOP targets which

prompted intervention, as opposed to patients who undergo
elective cataract surgery with Trabectome, who may be more
likely to already have well-controlled IOP and are hoping for
reduced medication dependence. Generally, patients who have
more severe disease are likely to have lower IOP targets than
those with mild disease. Although Trabectome as a stand-
alone procedure does show a significant reduction in IOP on
average in severe glaucomatous disease, further external fil-
tration surgery may be needed to achieve a lower IOP, reduc-
ing the rate of success in this group.
In our study, an average of two glaucoma medications was
required in both groups to maintain the target IOP even after
Trabectome was performed (Table 3). This was grossly a 14%
medication reduction in patient in both mild and moderate/
severe glaucoma. The difference in medication reduction be-
tween the two groups was not clinically significant (p = 0.67).
This data in part supports the assertion that even in patients
who have otherwise medically well-controlled IOP with open-
angle glaucoma, Trabectome can offer a benefit at the time of
elective cataract surgery.
In glaucoma patients with uncontrolled IOP needing cata-
ract surgery, combining external filtration surgery with cataract
extraction has long been a debated topic. This is primarily
because of the risks associated with traditional external filtra-
tion surgery. While combined phacoemulsification and
trabeculectomy or glaucoma drainage implant has had success
in IOP control, the risks of hypotony, choroidal effusions, cho-
roidal hemorrhages, bleb leaks, and endophthalmitis are not
insignificant [1, 6 17]. Trabectome, as well as other micro
incisional techniques, provide a safer alternative, leading to
higher adoption by surgeons of combined phacoemulsification
and micro incisional glaucoma procedures.
Although the traditional indicationfor micro incisional pro-
cedures has been in mild varieties of open-angle glaucoma,
there is increasing evidence to support the use of the
Trabectome in advanced, refractory disease. One study
looking at the success of the Trabectome following failed tube
shunt implantation showed a long-term success rate of 84%
[4]. Some patients with advanced disease who can achieve
appropriate IOP control with a combination of trabectome
and topical medication treatment may be spared of external
filtration surgery and the associated recovery and risks.
Overall, Trabectome is a low-risk means of achieving IOP
reduction and decreased medication dependence in patients
with mild, moderate, and severe OAG. The outcomes of this
study suggest Trabectome can be used successfully in the
wide range of glaucoma subcategories, and across the entire
spectrum of disease severity.
Compliance with ethical standards
Conflict of interest The authors declare that they have no conflict of
interest.
Graefes Arch Clin Exp Ophthalmol
Ethical approval All procedures performed in studies involving
human participants were in accordance with the ethical stan-
dards of the institutional and/or national research committee
and with the 1964 Helsinki declaration and its later amendments or
comparable ethical standards.
Informed consent This was a retrospective study and informed consent
was not required.
References
1. DeBry PW, Perkins TW, Heatley G et al (2002) Incidence of late-
onset bleb-related complications following trabeculectomy with
mitomycin. Arch Ophthalmol 120(3):297–300
2. Sit AJ, Khaja H (2008) Relationship between ablation arc length
and IOP with Trabectome surgery. AAO Scientific Poster 102
3. Ting JL, Damji KF, Stiles MC et al (2012) Ab interno
trabeculectomy: outcomes of exfoliation versus primary open angle
glaucoma. J Cataract Refract Surg 38(2):315–323
4. Mosaed S, Chak G, Haider A et al (2015) Results of Trabectome
surgery following failed glaucoma tube shunt implantation: cohort
study. Medicine 94(30):e1045
5. Francis BA. (2015) Trabectome combine with phacoemulsification
versus phacoemulsification alone: a prospective non-randomized
controlled surgical trial. A supplement of clinical & surgical
ophthalmology
6. Francis BA, Minckler D, Dustin L et al (2008) Combined cataract
extraction and trabeculotomy by the internal approach for
coexisting cataract and open-angle glaucoma: initial results. J
Cataract Refract Surg 34(7):1096–1103
7. Food US (2012) FDA 510 (k) Database Entry Neomedix NMX-
1000 (Trabectome). (2014) Available: http://www.accessdata.fda.
gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K040584. (Date of
access: March 27, 2017)
8. Mosaed S, Rhee D, Filippopoulous T et al (2010) Trabectome out-
comes in adult open-angle glaucoma patients: one-year follow up.
Clin Surg Ophthalmology 28(8–9):182–186
9. Minckler DS, Baerveldt G, Alfaro MR et al (2005) Clinical results
with the Trabectome for treatment of open-angle glaucoma.
Ophthalmology 112(6):962–967
10. Chan EW, Chiang PP, Wong TY et al (2013) Impact of
glaucoma severity and laterality on vision-specific function-
ing: the Singapore Malay eye study. Invest Ophthalmol Vis
Sci 54(2):1169–1175
11. Enders P, Schaub F, Adler W et al (2016) The use of Bruch’s mem-
brane opening-based optical coherence tomography of the optic
nerve head for glaucoma detection in microdiscs. Br J
Ophthalmol 101(4):530–535
12. Susanna R Jr, Vessani RM (2009) Staging glaucoma patient: why
and how? Open Ophthalmol J 17(3):59–64
13. Gedde SJ, Schiffman JC, Feuer WJ et al (2007) Treatment out-
comes in the tube versus trabeculectomy study after one year of
follow-up. Am J Ophthalmol 143(1):9–22
14. Tektas OY, Lutjen-Decoll E (2009) Structural changes of the tra-
becular meshwork in different kinds of glaucoma. Exp Eye Res
88(4):769–775
15. Allingham RR, Damji KF, Freedman SF, et al. (2012) Shields text-
book of glaucoma. Lippincott Williams & Wilkins
16. Singh K, Spaeth G, Zimmerman T et al (2007) Target pressure: the
glaucomatologist holy grail. Ophthalmology 7:629–630
17. Friedman DS, Jampel HD, Lubomski LH et al (2002) Surgical
strategies for coexisting glaucoma and cataract: an evidence based
update. Ophthalmology 109:1902–1915