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NR 10-12/2006
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Efficacy and safety
of deep sclerectomy and phacoemulsification and deep sclerectomy
in clinical material of Military Health Service Institute –
yearly observations
Skuteczność i bezpieczeństwo
głębokiej sklerektomii i fakoemulsyfikacji z głęboką
sklerektomią w materiale klinicznym WIM – roczna obserwacja
Rękas Marek, Wierzbowska Joanna,
Katarzyna Lewczuk, Anna Siemiątkowska, Andrzej Stankiewicz
From the Departament of Ophthalmology, Military Health Service
Institute in Warsaw
The Head: professor Andrzej Stankiewicz, Ph.D., M.D. |
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| Summary: |
Purpose: Comparison
of the effectiveness of nonpenetrated deep sclerectomy (DS)
as the only procedure in relation to operation combined
with phacoemulsification (FDS) in treatment of patients
with open-angle glaucoma based on yearly observation.
Material and methods: 67 eyes with open-angle
glaucoma were retrospectively analyzed. Applying
layer-systematic criteria 21 eyes after deep sclerectomy
with scleral implant (SKGEL/Corneal or T-flux/I-Tech)
were selected into group I (DS implant) and 23 eyes
after phacoemulsification with simultaneously performed
deep sclerectomy and scleral implants were selected into
group II (FDS implant). In control studies best corected
visual acuity (BCVA), intraocular pressure (IOP),
anterior chamber and fundus, were examined.
Postoperative complications and applied procedures were
analyzed especially controlling hypotensive effect (goniopuncture,
antimetabolites), as well as number of glaucoma
medications used. Tests were performed in 1 and 7 days
after surgery, and later after 1, 3, 6, 12 months.
Statistically test U Mann-Whitney was used as well as
pair sequence Wilcoxon test. Survival analysis was done
with Kaplan-Meier method with the use of log rank test.
Results: After 360 days of observation mean
values of IOP in group I was 14.3 ± 3.6 mmHg, and in
group II – 12.9 ± 3.0 mmHg. It was a decrease of mean
IOP by 29.6% (p=.000) and 41.4% (p=.000) in comparison
to preoperative IOP in particular groups. In both groups
fewer glaucoma medications were used after surgery and
the results were statistically significant (p<.05). As a
complete success rate was considered IOP of ≤ 18 mmHg
without glaucoma medications, and qualified success rate
was IOP of ≤ 18 mmHg without medications or with the
most of two glaucoma medications. Complete and qualified
success rate were achieved respectively in group I
(72.6% and 88.4%) and in group II (74.3% and 86.9%) at
the end of observation. In the entire observation there
were no statistically significant differences between
group I and 2 (p>.05). After 360 days of observation
there was no statistically significant difference
between mean BCVA in group I and II (p>.05).
Conclusions: DS with scleral implant performed as
a single procedure or FDS is effective treatment in
open-angle glaucoma. |
| Słowa kluczowe: |
głęboka sklerektomia,
głęboka sklerektomia z fakoemulsyfikacją, jaskra
otwartego kąta. |
| Key words: |
deep sclerectomy,
phacoemulsification and deep scelerectomy, open
angle-glaucoma. |
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Introduction
Despite the fact that trabeculectomy is still the most
frequently used operation in open-angle glaucoma, it is not
difficult to notice the importance of nonperforated techniques
in recent years. Development of these techniques was influenced
by desire to limit complications after classical perforating
surgeries, which resulted in opening of the anterior chamber (hypotonia,
making shallow the anterior chamber, choroid detachment,
development of cataract) and further progress was stimulated by
promising surgical results. Not without the meaning for the
later is further growing offer of intrascleral implants and
correct intra and post surgical strategy, which includes
antimetabolites and laser procedures. In essence DS comes to
development of filtration membrane (trabeculo-Descemet’s
membrane), composed of Descemet’s membrane and Schlemm’s canal
deprived of exterior wall during surgery. Filtration membrane
filters aqueous to decompression space, which is formed by
lamellar dissected sclera. Decompression space should have about
8 mm3 in volume. At the present time in order to preserve this
space different implants are used. Implant, which is present in
decompression space for several months between dissected sclera
prevents the fibrosis of filtration space, besides that its
hydrophilic properties increase drainage of aqueous from
Schlemm’s canal and is responsible for greater reduction of IOP.
The first used were absorbable implants made of collagen,
later-from sodium hialuronide, and as the latest were introduced
non absorbable acrylic implants (Aquaflow, SKGEL, T-flux).
Reduction in IOP is mainly a result of the reduction of drainage
resistance of aqueous in the distal part of Schlemm’s canal;
other mechanisms for hypotensive effect are: flow through sclera,
microperforations of anterior chamber, opening of previously
inactive foci in Schlemm’s canal and finally uveoscleral
drainage.
In post surgical management, for the purpose of functional
improvement of the filtration membrane and confirming proper
functioning of filtration bleb it is common to use goniopuncture
with Nd:YAG laser and antimetabolites.
The purpose of this paper was to compare the effectiveness of DS
as a single procedure in relation to FDS in treatment of
patients with open-angle glaucoma based on yearly observation.
Materials and methods
Retrospective analysis was used in 67 eyes in 60 patients with
open-angle glaucoma, 40 females and 20 males, operated in the
Departament of Ophthalmology, Military Health Service Institute
in Warsaw from October 2004 until November 2005. In the group of
67eyes there were eyes after DS with scleral implant (SKGEL/Corneal
or T-flux/I-Tech), 21 eyes-group I (DS implant). The remaining
47 eyes were eyes after FDS and scleral implants. Because groups
were diverse as to the number, from the FDS group 23 eyes were
chosen using layer-systematical criteria-group II (FDS implant).
It was open-angle glaucoma as an indication for surgery, which
was treated with at least two glaucoma medications without
satisfactory control of IOP or progression of changes in the
visual field, and in 23 eyes co morbid cataract.
Pre surgical examination included: distance and near BCVA,
applanation tonometry, gonioscopy, pachymetry, evaluation of the
anterior chamber with biomicroscope, fundoscopic examination in
stereoscopic image, statical perimetry with threshold strategy
using computerized perimeter Centerfield/Oculus. In 21 eyes DS
was performed in one of upper quadrants, and in 23 eyes with
concurrent cataract simultaneous phacoemulsification was
performed.
Operations were performed by one surgeon (M.R.), in retro bulbar
analgesia with 2% Xylocaine augmented by NLA. After cut off of
ocular conjunctiva from corneal limbus in upper quadrant,
scleral flap was dissected superficially measuring 5.0 x 5.0 mm
at the base in limbus. Later a flap measuring 3.5 x 3.5 mm was
dissected in the deep sclera reaching sclera spur. In eyes with
concurrent cataract in subsequent step phacoemulsification
performed from temporal clear cornea incision, combined with
coiling lens implant in the posterior chamber into capsular bed.
Later deep scleral flap was dissected showing Schlemm’s canal
and Descemet’s membrane included in filtration membrane, (trabeculo-Descemet’s
membrane). Deep scleral flap was cut off at the Schwalbe line
and outer wall of Schlemm’s canal was removed. After positioning
of the implant in the scleral bed (acrylic implant was sutured
with Nylon 10-0), the superficial flap was closed with single
sutures with Nylon 10-0 and conjunctiva was sutured with single
Vicryl 8-0 sutures.
In control examination BCVA, IOP, anterior chamber and fundus
were examined, post surgical course was analyzed, including
complications, applied procedures fixing hypotensive effect (goniopuncture,
antimetabolites) and amount of used medications for glaucoma.
Examinations were done in 1 and 7 days after surgery, and 1, 3,
6, and 12 months. In case of elevated IOP (>15 mmHg), which was
due to filtration membrane failure (lack of or poorly developed
filtration bleb), goniopuncture with Nd:YAG laser was used.
Elevated IOP (>15 mmHg) with signs of inflammation or fibrosis
of the filtering bleb were indication to begin treatment with
antimetabolites. 5-fluorouracyl (5-FU) was used in dose of 5.0
mg, which was given subconjunctivally, 180 degrees from surgical
wound, in the area of conjunctival crease. Injections were given
daily for 5 subsequent days, and if necessary it was repeated
after one week. Antimetabolites were discontinued earlier when
IOP was well regulated or side effects occurred. Four weeks
after surgery all patients received in the conjunctival sack
antibiotic with corticosteroid and NSAID.
Complete success rate was defined as IOP ≤ 18 mmHg without
glaucoma medication and qualified success rate as IOP ≤ 18 mmHg
without and with glaucoma medications.
In statistical analysis test U Mann-Whitney was employed as well
as pair sequence Wilcoxon test, Ch-square Yates test and Fisher
test. Survival analysis was done with Kaplan-Meier method with
usage of log rank test.
Results
Studied groups were homogenous for age, sex, observation time
and preoperative IOP (p>.05) (Table I). The mean observation
time was 360 days in both groups (Table I).
Intraocular pressure control
Mean IOP in group I before surgery was 20.3 ± 5.9 mmHg and
was decreased in day one after operation by 57.6% and was 8.6 ±
4.3 mmHg (p=.000). In group II mean IOP in day 1 after surgery
decreased by 45.0% from the original 22.0 ± 7.6 mmHg to 12.1 ±
5.2 mmHg (p=.000). After 360 days of observation mean values of
IOP in group I were 14.3 ± 3.6 mmHg. and in group II 12.9 ± 3.0
mmHg. It was decrease in mean IOP by 29.6% (p=.000) and 41.4%
(p=.000) respectively in particular groups as compared to
preoperative IOP (Figure 1). Values of IOP in studied groups are
shown in Table II. Statistically significant differences between
group I and 2 were noted in day 1 after surgery (p<.05) (Table
II).
Medications
In both groups after surgery fewer medications were used
than before operation, and results were statistically
significant (p<.05) (Table III). In group I 360 days after
operation 13 patients (61.9%) did not require glaucoma
medications. In group II as many as 82.6% (19 patients) did not
require glaucoma medications in the same time after surgery.
There were no statistically significant differences between a
number of used glaucoma medications in both studied groups at
the end of observation (Table III).
Surgical success
Complete success rate was IOP of ≤ 18 mmHg 360 days after
surgery without glaucoma medications, and qualified success rate
was IOP ≤ 18 mmHg without medications or with two medications at
the most. Cumulative probability of success based on above
criteria for particular periods in observation are shown in
Table IV. The Kaplan-Meier curves of survival analysis for full
and satisfactory criteria are shown in Figure 2 and 3. In the
entire observation period there were no statistically
significant differences between group I and II (p>.05) (Table
IV, Figure 2 and 3).
Best corrected visual acuity
Mean BCVA in group I one day after surgery was decreased from
0.77 ± 0.27 to 0.62 ± 0.27, and a month later returned to
preoperative values 0.81 ± 0.22 and remained unchanged until the
end of observation 0.79 ± 0.21 (p>.05) (Table V). After 12
months from surgery visual acuity did not change in 13 patients
(62.0%), improved by 1-2 Snellen lines in 3 patients (14.0%) and
deteriorated by 1-2 Snellen lines in 5 patients (24.0%) due to
cataract (2 patients-10.0%) and age-related macular degeneration
(3 patients – 14.0%). Mean BCVA in group II was changed from
0.40 ± 0.19 before surgery to 0.43 ± 0.26 one day after surgery,
to 0.75 ± 0.27 after one month and remained the same for the
duration of observation (p<.05) (Table V). At the end of
observation visual acuity improved in 21 (91.0%) patients, and
in 2 (9.0%) patients was unchanged; due to age-related macular
degeneration. After 360 days there was no statistically
significant differences between mean BCVA between group I and II
(p>.05) (Table V, Figure 4)
Goniopuncture, antimetabolites
Goniopuncture Nd:YAG was performed in 6 eyes in group I
(28.6%) and in 5 eyes in group II (21.7%) (p>.05) (Table VI).
Subconjunctival injections with 5-FU was performed in 5 eyes in
group I (23.8%), and in 2 eyes in group II (8.9%) (p>.05) (Table
VI). Mean dose of antimetabolites was 13.0 mg in group I, and
15.0 mg in group II, and mean number of injections was 2.4 and
3.0 respectively.
Cocmplications
Early post-surgical complications included: transient
hypotonia (<6 mmHg) in 5 eyes (23.8%) in group I and in 6 eyes
(26.0%) in group II, elevated IOP (>20 mmHg) in 2 eyes (9.5%) in
group I and in 3 eyes (13.0%) in group II. Shallow the anterior
chamber was observed in both groups in 2 eyes (9.5%) in group I
and in 1 eye (4.3%) in group II. Choroid detachment (3
eyes-13.0%), and hemorrhage into vitreous body (1 eye – 4.3%)
was noted in early postoperative period only in group II. Late
postoperative complications included: fibrosis of the filtration
bleb was noted in 6 eyes (28.6%) in group I and in 4 eyes
(17.3%) in group II. After introduction of 5-FU transient
epitheliopathy was observed in 4 eyes (19.0%) in group I and in
2 eyes (8.7%) in group II. Progression of cataract was noted in
2 eyes (9.5%) in group I. Cystoid macular edema was noted in 2
eyes (9.5%) in group I (Table VII).
Discussion
Traditional approach in treatment of glaucoma, assuming
gradual steps from pharmacological therapy, through laser
therapy to surgical treatment, after maximizing available means
and methods in particular form of therapy, underwent
verification in recent years. Published results from multicenter
prospective trials (e.g. The Advanced Glaucoma Intervention
Study, AGIS) have influenced the verification with associated
prostaglandin analogues, and return of pharmacological „philosophy”
toward safety and quality of life for the patient.
The alternative for combined pharmacotherapy is nowadays
frequently non penetrated surgery, providing decrease in IOP and
preservation of visual acuity. Non penetrated techniques,
presented for the first time by Epstein and Krasnow at the end
of 50’s in the last century, later improved in the 80’s by
Russian School (Fiodorow, Kozlow) and North American (Zimmerman),
through several years they remained in the shadow of classical
trabeculectomy, as less effective. Rediscovered again 10 years
ago, considering high safety profile, they thrive nowadays,
which is determined by biotechnological advances, enabled use of
high class surgical microscopes and lasers, variety of scleral
implants as well as pharmacological strategy of tissue
regeneration. |
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The purpose of this work was to
show effectiveness and safety of phacoemulsification and
sclerectomy and deep sclerectomy in the material of Departament
of Ophthalmology, Military Health Service Institute in Warsaw
based on 12 months observation.
In day 1 after surgery, in 21 eyes operated by the DS method,
mean IOP was lower by 57.6% than before surgery, and in 23 eyes
operated with FDS method- by 45.0%, only for this comparison it
was statistically significant difference. Early, transient
hypotonia (<6 mmHg) was observed in 28.6% and 17.3% respectively;
similar results were noted by D’Eliseo (32.2 vs. 20.0%) (1).
Other authors had lower percentage (1.0-8.0%) (2-5). According
to Shaarawy (6), hypotonia below 6 mmHg in the first
postoperative day has positive prognostic value for the future
operative success.
In our own studies, starting from day 7 post surgery in all
comparisons statistically significant profile of IOP reduction
in relation to pre operation were observed. In day 7 after
surgery reduction of mean IOP achieved 50.7% in group I and
51.8% in group II, after a month - 29.1% and 42.7% respectively,
after 3 months 32.0% and 47.3%, after 6 months – 31.0% and 41.4%
and after 12 months – 29.6% and 41.3%. Despite the fact that
from day 7 post operation there were no statistical differences
noted between groups, in all comparisons lower IOP values were
noted in the FDS group. Similar results after a year observation
obtained D’Eliseo (13.1 mmHg vs. 15.2 mmHg) (1). Complete
success rate, defined as IOP <20 mmHg without glaucoma
medications, was achieved in 90.0% of eyes after FDS and 61.9%
of eyes after DS alone. Differences stem from easier aqueous
drainage in the pseudophakic eye, due to pulling of the ciliary
rim and processes by contracting lens capsule and also by
deepening in central and peripheral part of the anterior chamber
and lower risk of impaction of peripheral iris in the filtration
membrane window and development of so-called internal filtration
block (1).
In our own studies complete success rate was achieved in 72.6%
of eyes in group I and 74.3% of eyes in group II, and qualified
success rate in 88.4% and 86.9% respectively. Studies done by
other authors confirm high efficacy of DS in over a year
observation. Demailly (4) in 219 eyes, complete success rate
(IOP<21 mmHg without meds) noted in 89.0% of eyes after 6 months
and 76.0% after 16 months, and qualified success rate (with meds)
in 97.0% and 79.0% respectively. Similar results were obtained
by Karlen (7). In longer, 36-months observation complete success
rate (criteria as above) was achieved in 97.0% of eyes after 6
months, 71.0 % after 24 months and 45.0% after 36 months, and
qualified success rate in 99.0%, 98.0% and 98.0% of eyes
respectively. Shaarawy (8) in 60-months observation of 60 eyes
complete success rate noted in 62.0% of cases and qualified
success rate in 95.0%. In the above mentioned studies other
criteria are noted than authors of this work (IOP<21 mmHg vs. 18
mmHg in this work), which determines higher percentage of
efficacy.
Employed surgical therapy allowed discontinuation of glaucoma
medications in 61.9% of eyes in group I and 82.6% in group II.
Similar results were obtained by D’Eliseo (61.9 vs. 90.5%) (1).
In our own study mean number of glaucoma medications was
decreased from 2.47 (group I) and 2.24 (group II) before surgery
to 0.71 and 0.23 respectively after 12 months from operation.
Other authors in several year observations confirm stable
hypotensive effect of DS. Karlen (7) in a group of 100 eyes
achieved reduction of mean number of glaucoma medications from
2.2 ± 0.7 before surgery to 0.2 ± 0.4 3 years from surgery, and
Dahan (9) in the material of 48 eyes after 30 months observation
noted decrease of the number of glaucoma medications from 2.3 ±
1.0 to 0.3 ± 0.6 in eyes without implants and complete
discontinuation of medications in eyes where DS with implant was
performed. Shaarawy (8) in group of 60 eyes reports almost
5-fold decrease in mean number of glaucoma medications (2.3 vs.
0.49) after five years from operation.
In case of filtration membrane failure and IOP > 15 mmHg
goniopuncture was done with laser Nd:YAG. This therapy was used
in 28.6% of eyes in group I and 21.7% of eyes in group II, and
it was performed in the first month after surgery. Similar or
higher percentage of applying this procedure (23.0-47.0%) was
noted by other authors (7, 8, 9, 10). Breaking of the filtration
membrane caused a change from non penetrated surgical method to
penetrated.
In our own material fibrosis and encapsulation of the filtration
bleb was observed in 23.8% of eyes in group I and 8.9% of eyes
in group II, and percentage was lower than cited by other
authors (24.0-34.0%) (7, 8). The treatment of choice in those
cases were subconjunctival injections of 5-FU (single dose
5.0 mg); mean number of injections was 2.4 and 3.0 respectively.
Although recommended by Fluorouracil Filtering Surgery Study
Group (FFSSG) (12), cumulated dose of 5-FU is 35-105 mg (7-21
injections), generally lower dosages (22-35 mg) are used (12,
13). Complications observed in our study after injections of
antimetabolites were transient and frequency was lower than
reported by other authors (13).
In group II, early hypotonia was associated with minimal (mean
1.5 Snellen line) and short-lived decrease in visual acuity in
the first week after surgery, and in group I improvement in
visual function was observed. Besides the first week after
surgery visual acuity in the group of 21 eyes, which underwent
DS, did not change. Non penetrated character of the operation
influenced protection against inflammatory reaction in early
post operative period in the anterior chamber and long lasting
hypotonia, and in late stage-development of the cataract.
Observed progression of lens clouding in 9.5% of eyes was not
higher than natural lens opacification in a year time in the
comparable age group population (7) and was lower than in the
eyes after trabeculectomy (14).
In our studies DS and FDS were proven to be safe. Presence of
blood in the anterior chamber, noted in the first day post
surgery in 1 patient (4.8%) in group I and 2 patients (8.7%) in
group II, was probably the effect of backwards drainage from
sclera through trabeculum or microperforation of the filtration
membrane; frequency of this complication by other authors is
around 3.0-7.0% (6, 7). Hemorrhage into vitreous body observed
in the first day after surgery in one patient was the
consequence of central retinal vein thrombosis. Other
complications (shallow anterior chamber, choroid detachment,
cystoid macular edema were encountered sporadically (in
2.0-3.0%) and were reversible.
In this work we did not obtain statistically lower values of IOP
in group of eyes treated with FDS in comparison with the group
of eyes treated with DS alone-some tendency was noted. Observed
tendency toward greater reduction of IOP in eyes operated
simultaneously for glaucoma and cataract, is confirmed by
observations of other authors (6, 15, 16), who prefer in eyes
with co morbid cataract combined procedure as a method of choice.
FDS is necessary to consider especially in patients with a goal
of low IOP and high risk of scar formation in the area of
filtration bleb. Combined procedure lowers the risk associated
with two subsequent surgical procedures and double anesthesia
and influences quick recovery of visual acuity. To fully assess
presented surgical technique it seems necessary to continue
studies on greater clinical material.
Conclusions
1. DS and FDS are effective and safe surgical methods in the
treatment of open-angle glaucoma.
2. Subconjunctival injections with 5-FU through inhibition of
inflammatory reaction in the area of filtration bleb and
goniopuncture with YAG laser improving filtration through
filtration membrane are effective methods in fixing the
filtration pathway.
3. DS used as a single method does not influence decrease in the
quality of life through lowering of visual acuity, but performed
simultaneously with phacoemulsification contributes to
significant improvement of visual acuity.
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Praca wpłynęła do Redakcji 18.07.2005 r. (863).
Zakwalifikowano do druku 24.10.2006 r.
Adres do korespondencji (Reprint
requests to):
dr n. med. Marek Rękas
ul. Karola Szymanowskiego 63
05-260 Marki |
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