Prospective Randomized Study Comparing Combined

Phaco-ExPress and Phacotrabeculectomy in Open Angle

Glaucoma Treatment: 12-Month Follow-Up

Musa Haidar Azinuddin

Abstract
Purpose of the Study. To compare the efficacy and safety of phacotrabeculectomy (P-Trab) and
phacoemulsification with the ExPress (P-ExPress) mini glaucoma shunt implantation.
Study Plan. Prospective randomized study. Material and Methods. 85 eyes with cataract and unregulated
open angle glaucoma. There were 46 eyes in the P-ExPress and 39 the P-Trab group. Intraocular pressure
(IOP), the number of antiglaucoma medications, qualified and complete surgical success (defined as IOP
18.0 mmHg), visual acuity (CDVA), the number of endothelial cells, and postoperative complications and
additional procedures were assessed.
Results. After 12 months of observation, the average IOP in the P-Express group went from 26.4 9.3 down
to 17.1 5 mmHg ( < 0.05) and from 27.9 12.9 down to 15.9 2.7 mmHg in the P-Trab group ( < 0.05).
No significant differences in the amount of medications used after surgery and CDVA were discovered
between the groups. In the P-ExPress group, greater loss of endothelial cells was noted (CDloss%),
compared to the P-Trab group.
Conclusions. Both P ExPress and P-Trab have comparable efficacy and similar early postoperative
complication profile. The presence of additional implant (as is the case of the ExPress mini glaucoma shunt
implantation)
may
cause
progressive
loss
of
endothelial
cells.

Introduction
Glaucoma
hypotensiv
e
effectivene
ss

hypotensiv
e
effectivene
ss

less tissue
traumatizati
on

Phaco+trabeculectomy

P-ExPress
mini glaucoma shunt
implantation

less tissue
traumatizati
on

safety
profile

safety
profile

Gold
Standar

Alternatif
Mayor
complication :
Corneal
Endotelia
decompensati
on

Material
& Methods
Study Design
Patients
Procedure
Preoperatif
Postoperatif
Analisis

Clinical Study
Prospective Randomized Study

Material
& Methods
Methods
Patients

Procedure
Preoperatif
Postoperatif
Analisis

SAMPLE
Patients with primary open angle glaucoma
(POAG)
secondary pseudoexfoliative glaucoma (PEX)
pigmentary glaucoma (PG)
intraocular pressure (IOP > 21 mmHg) was
not achieved
despite maximally tolerated topical and
systemic medication
qualified for the treatment

Inclusion criteria

- Well documented progression of

visual field defects
- Significant diurnal variations in the
IOP
- Lack of compliance to anti glaucoma
therapy
- Allergy to topical drugs
- Written consent to participate in the
study for at least 12 months was
obtained from all patients after they
were informed about the nature of
the procedure and other surgical
alternatives

Exclusion criteria

- Lack of consent to participate in

the study,
- Previous surgical and laser
procedure within the eye
- Closed or narrow angle glaucoma
- Diabetes
- Advanced macular degeneration
- Active inflammatory disease

Material
& Methods

85 eyes
Randomized

Methods
Patients
Procedure

Phacotrabeculectomy Group

P-ExPress Group

39 eyes

46 eyes

Preoperatif
Postoperatif
Analisis

Basic Examinations
Intraocular pressure (IOP)
Uncorrected distance visual acuity (UDVA)
Corrected distance visual acuity (CDVA)
Examination of anterior and posterior segments
of the eye.
The central corneal thickness (CCT)
The number of Endothelial cells per square
millimetre (CD)
In addition, the measurement of axial length of
the eye (AXL)

Material
& Methods
Methods
Patients
Procedure
Preoperatif
Postoperatif
Analisis

Follow
Up

IOP
Corrected distance visual acuity
(CDVA)
Anterior chamber & the bottom of the
eye
Postoperative period
Complicatins
The number of antiglaucoma
medications

Antibiotic and
steroid
topically for 4 weeks

1st day

7th day

Visual field test

and
specular
microscopy
topography

1st
month

3rd
month

6th
month

9th
month

12th
month

Visual field test

and
specular
microscopy
topography

Material
& Methods
Methods
Patients
Procedure
Preoperatif
Postoperatif
Analisis

The success rate was

analyzed in two categories:
Qomplete surgical : as IOP
18 mmHg without
antiglaucoma medications
Qualified : as IOP 18
mmHg with a maximum of
two antiglaucoma
medications

Failure : occurred when the

IOP > 18 with or
without antiglaucoma
medications or when
the
eye
required
further
surgical
intervention

Material
& Methods
Methods
Patients
Procedure
Preoperatif
Postoperatif
Analisis

The Shapiro-Wilk test was used to assess the compliance of the

parameters with normal distribution. For the one-way analysis of
variance (ANOVA) purposes, the post hoc Bonferroni test was used
in multiple comparisons or the Kruskal-Wallis test with Dunns
analysis of contrasts in the case of noncompliance of the
parameters with normal distribution. The analysis between the
groups was performed using Students -test or Mann-Whitney
test. The frequency table and Chi-squared test can be used for
comparing quality characteristics. The significance level < 0.05
was adopted for the purposes of calculations.

Results
Intraocular pressure (IOP) mean values, median values, standard deviations, and range in the phaco-ExPress (PExPress) and phacotrabeculectomy (P-Trab) groups at specific times after surgery

Results
Amount of hypotensive drugs: mean values, median values, standard deviations, and range in the phaco-ExPress (PExPress) and phacotrabeculectomy (P-Trab) groups at specific times after surgery

Results
Visual acuity (logMAR) mean values, median values, standard deviations, and range in the phacoExPress (P-ExPress) and phacotrabeculectomy (P-Trab) groups at specific times after surgery

Results
Corneal epithelial cells density CD, CDloss%: mean values, median values, standard deviations, and range in the P-ExPress and
P-Trab groups at specific times after surgery.

Results

Postoperative
complications

Discussion
P-thrabeculectomy
The most commonly reported complications after trabeculectomy include
bleeding into the anterior chamber, making the anterior chamber shallow and
choroidal detachment.
The CDVA deterioration occurs in 3050% of the cases
surgery may achieve a success rate of 85%90%.

P-ExPress

The ExPress mini glaucoma shunt implantation was proposed as a lessinvasive procedure, with lower rate of complications resulting from
postoperative hypotension.
The ExPress mini glaucoma shunt is also used in eyes with advanced
glaucoma, where it is necessary to maintain the target intraocular pressure at
the lowest possible level.
Surgical success rate goes up to 87%

Discussion
Statistically significant difference in the CD and the CD loss%

Cornea condition depends

on various factors such as :
The distance from the
rear surface of the cornea
The material of which the
implant is made
Perioperative trauma
The patient condition
before surgery.

According to some theories,

such damage is caused by
increased
fluid
flow around the tip of the
tube, inflammatory reaction
in
the
anterior chamber, transitory
contact between the tube
and
the cornea or between the
tube and the uvea, or
immune
response evoked by the
presence of a foreign body in
the eye

Other theories suggest

that persistently elevated
IOP directly or indirectly
induces hypoxia, thereby
damaging
the
endothelium

Conclusions

The ExPress mini glaucoma shunt implantation is increasingly popular in surgical treatment of glaucoma
as an alternative to traditional trabeculectomy because it is more predictable and allows the avoidance
of many side effects.
Hypotensive effect of both of these procedures is similar; however, it should be taken into account that
the ExPress mini glaucoma shunt implantation has its own adverse effects profile, including corneal
complications with significant, continued loss of endothelial cells in a greater extent than
phacotrabeculectomy

Critical Appraisal
PICO
Patients

: Open Angle Glaucoma

Intervention : Phacoemulsification with the ExPress (P-ExPress) mini glaucoma shunt implantation
Comparasion

: Phacotrabeculectomy (P-Trab)

Outcome

Intraocular pressure(IOP)

The number of antiglaucoma medications,

Visual acuity (CDVA)
The number of endothelial cells,
Postoperative complications and additional procedures were assessed

I. Are the results of the trial valid?

Did the trial address a clearly focused issue? Yes Cant tell No

PICO

Was the assignment of patients to treatments randomised? Yes Cant tell No

The toss of a coin was a method used to decide the assignment of a given patient into one of
these study groups
Were patients, health workers and study personnel blinded? Yes Cant tell No

Were the groups similar at the start of the

trial? Yes Cant tell No

Aside from the experimental intervention,

were the groups treated equally? Yes
Cant tell No

Were all of the patients who entered the trial

properly accounted for at its conclusion?
Yes Cant tell No

II. Results

Selection of outcomes
Does the article report all relevant outcomes including side effects? Yes Cant tell No
Effect size
Was there a difference between the outcomes of the treatments, and how big was the difference ?
How reliable is the estimate: what are the confidence intervals?

III. Applicability

Can the results be applied in your context? (or to the local population?) Yes Cant tell No

Is your working environment so different from the one in the study that the methods could not be
used there? Yes Cant tell No

Thank

You!

Alhamdulillah, Semoga bermanfaat :)