Американский Научный Журнал EFFECTIVENESS OF DIFFERENT METHODS OF SURGICAL TREATMENT OF DIABETIC MACULOPATHY IN PATIENTS WITH TYPE 2 DIABETES

To study the effectiveness of different technologies of diabetic maculopathy (DMP) surgical treatment in patients with type 2 diabetes (T2D) Скачать в формате PDF
American Scientific Journal № ( 28) / 20 19 27

EFFECTIVENESS OF DIFFERENT METHODS O F SURGICAL TREATMENT OF DIABETIC
MACULOPATHY IN PATIE NTS WITH TYPE 2 DIAB ETES

Yuliia Panchenko
PhD, Candidate of Medical Sciences
Kyiv Clinical Ophthalmology Hospital “Eye Microsurgery Center”, Ky iv, Ukraine
Medical center “LASER Plus”, Lviv, Ukraine

Purpose. To study the effectiveness of different technologies of diabetic maculopathy (DMP) surgical
treatment in patients with type 2 diabetes (T2D).
Method. 313 patients with T2D (313 eyes), with DM P and primary (group 1; n=40), moderate or severe non -
proliferat ive diabetic retinopathy (NPDR; group 2; n=92), and proliferative diabetic retinopathy (PDR; group 3;
n=181) were observed. The severity stages of both dia betic retinopathy (DRP) and DMP was d etermi ned according
to the International Clinical Severity Scale of the American Academy of Ophthalmology (2002). The patients
received four types of surgical treatment: 78 patients underwent three -port closed subtotal vitrectomy (CSV); 85
patients besides vitre ctomy additionally underwent inner limiting membrane (ILM) peeling in the macular region;
81 patients underwent panretinal laser coagulation (PRLC) of the retina additionally to CSV and ILM peeling, and
69 patient s additionally to all these intervent ions u nderwent cataract phacoemulsification (PHACO). The Statist ica
10 program (StatSoft, Inc., USA) was used for statistical processing of the obtained data.
Result. The effectiveness of DMP surgical treatment amounted to 70.3 %; relapses occurred in 23.0 % of
cases at the 1 st month of follow -up, at the 3 rd month — in 18.2 %, at the 6 th month — in 10.2 % and after 1 year
— in 24.9 % of cases. The effectiveness of the applied methods was as follows: CSV – 67.9 %, CSV + ILM peeling
– 72.9 %, CSV + ILM peeling + P RLC – 71.6 %, CS V + ILM peeling + PRLC + PHACO – 68.1 %. These
differences we re not statistically significant (p=0.87). The relapse rate at different follow -up periods did not differ
significantly in terms of treatment methods; only after 1 month of the fo llow -up the pati ents who underwent
combined methods of surgical treatment (CS V with ILM peeling, PRLC with ILM peeling, PRLC with PHACO)
experienced the relapses more frequently – 31.9 % (p=0.025). After CSV only, as well as after the combined
application of all surgical interventions (CSV, ILM peeling, PRLC, PHACO) all the relapse s were early, and the
majority of them (77.3 and 80.0 % respectively) were persistent. In other variants of surgical intervention the
majority of relapses (91 -96 %) were determine d as the early p ersistent and late ones. The effectiveness of surgical
treatm ent has been reducing by retinopathy severity and amounts to 72.5 % in primary NPDR; to 77.2 % in
moderate and severe NPDR, and to 66.3 % in PDR. The patients with PDR demonstrate d both a higher relapse
rate (33.7 %) and a higher relapse severity (a number of late relapses in patients in group 3 was 2.3 times greater
than in the patients of groups 1 and 2; p=0.001).
Conclusion. The conducted studies have demonstrated high effective ness of all meth ods which in a greater
degree depended on the retinopathy sev erity, and were the least effective in PDR.
Key words: diabetic maculopathy, type 2 diabetes, surgical treatment, technologies, effectiveness.

The development of diabetic retinop athy (DRP)
and d iabetic maculopathy (DMP) is the main cause of
disability du e to the central vision impairment in type 2
diabetes (T2D) [1 -3]. The patients with T2D
demonstrate the signs of DRP in 10 -15 years, and after
the period of 30 years 90 % of diabe tic patients hav e
this vision impairment [4]. According to various
authors’ data, a DMP development is observed in 3 -
38 % of patients with non -proliferative DRP, in 20 -
63 % of patients with pre -proliferative DRP, and this
number increases to over 70 % in p atients with
pro liferative DRP [5].
DMP is manifested through microaneurysms ,
intraretinal microvascular abnormalities (IRMA), solid
exudates, ischemia and posterior exfoliation of the
vitreous body in the macula, and macular edema [1 -3].
The changes in th e vitreous body and posterior hyaloid
membrane (PHM) are very important. The changes in
PHM impair retinal metabolism, and cause and
maintain macular edema. An incomplete self -
detachment of the vitreous body can also form the
tangential macular tractions, which explains t he DMP
resistance to laser coagulation, intravitreal
cortico steroids injections and anti -VEGF drugs [3, 5].
The vitreomacular traction (VMT) syndrome can be
accompanied by DMP, and in this case an extension of
the traction causes a vitreoma cular separation and
cystoid changes [6].
The surgical treatment, namely vit rectomy with
endolazercoagulation of the retina, tamponade of the
vitreous cavity, removal of the posterior hyaloid
membrane and, if needed, with internal limiting
membrane peeling (ILM) of the re tina, is used for the
treatment of DMP in forms which are mo re severe and
more resistant to conservative and laser methods, as
well as to anti -VEGF therapy [1, 3, 7]. Vitrectomy is an
effective procedure for DMP treatment, and the effect
can be improved by an additional ILM peeling, without
increasing the frequency of intra - and postoperative
complications [8]. Vitrectomy has been shown to lead
to structural and functional improvement of certain
regions of the retina, including the macula, h owever,
central vision improvement is not much better than
when laser interv ention is used [9]. For example, visual

28 American Sci entific Journal № ( 28) / 20 19
acuity in patients with nontractional macular edema
who underwent pars plana vitrectomy with and without
ILM peeling was not significantly d ifferent [10]. P ars
plana vitrectomy combined with cataract surgery in
patie nts with T2D has achieved good results without a
significant increased risk of visual acuity decrement or
other complications, which indicates a high
effectiveness of the combined surgical interve ntion
[11].
Purpose of the study – to study the effectivenes s
of different variants of vitreoretinal interventions by the
number of DMP relapses in patients with T2D.
Materials and methods of the study. 313
patients with T2D (313 eyes), wit h DMP and primary
(group 1; n=40), moderate or severe non -proliferative
diab etic retinopathy (NPDR; group 2; n=92), and
proliferative diabetic retinopathy (PDR; group 3;
n=181) were observed by us.
All the patients und erwent the conventional
ophthalmic exa minations, including visometry,
Humphrey visual field testing, refractometry ,
tonometry, biomicroscopy, gonioscopy,
ophthalmoscopy with a Volk Super/Field (NC USA)
aspheric lens and a Goldmann three -mirror contact
lens . The patients underwent a spectral do main optical
coherence tomography (OCT) on Optopoltechnology
device, SOCT, C opernicus REVO (Retina3D protocol,
RetinaRaster) and OCT using Angio mode
(RetinaAngio protocol, wide 6x6 mm). The fundus of
the eye was also examined with fundus camera with
photo graphing in 7 standard fields according to the
modified Airlie House ETDRS s ystem of clinical
features classification.
The severity stage of DRP and DMP was
determined according to the International Clinical
Diabetic R etinopathy and Diabetic Maculopathy
Severity Scale of the American Academy of
Ophthalmology (2002). [12].
The prog ressive reduction of visual acuity, visual
field changes in the central and paracentral
departments, changes in quality of vision due to NPDR
with refractory macular edema or macul ar edema with
tangential tractions, which appeared due to incomplete
detachm ent of the posterior hyaloid membrane of the
vitreous body, as well as due to PDR with refractory
macular edema, epiretinal membranes, and tan gential
and axial retinal tractions of the retina and the threat for
tractional retina detachment, and also hemoph thalmos,
preretinal and subhyaloid hemorrhages were the
indications for a surgical intervention.
In this study the patients received four type s of
surgical treatment. 78 patients u nderwent a three -port
closed subtotal vitrectomy (CSV) 25+ on the
Constellat ion Vision System device (Alcon, USA)
using the Constellation TOTALPLUS cassette,
combined 7500СРМ, 25+ caliber (Alcon, USA). An
extrusion lin e was used for posterior exfoliation o f the
vitreous body, posterior hyaloid and epiretinal
membranes were removed with a vitreotome or vitreal
forceps. Tangential and axial retinal tractions were
removed as well. Vitrectomy of the extreme peripheral
retin a was performed by means of sclerocomp ression.
20 % gas -air mixture C3F8 was injected into the
vitreous cavity. Th e trocars were removed and the ports
were sealed. Besides vitrectomy 85 patients
additionally underwent ILM peeling in the macular
region 2.5 -3.5 mm in diameter with a preliminary
injection of MembraneBlue dye into the vitreous cavity
for clear ILM visuali zation. Besides CSV and ILM
peeling 81 patients additionally underwent panretinal
laser coagulation (PRLC) of the retina with 25 -gauge
endolas er probe. Additionally to all these in terventions
69 patients underwent cataract phacoemulsification
(PHACO). All patients were examined in 1, 3, 6 months
and in 1 year after the surgery. The relapse rate of the
surgical treatment was determined by the pre sence of
DMP signs (microhemorrhage, I RMA, solid exudates,
etc.), and macular edema.
The Statistica 10 program (St atSoft, Inc., USA)
was used for statistical processing of the obtained data.
A distribution of variation series that differs from
normal one ( p<0.05) was determined after conductin g
Kolmogorov -Smirnov, Anderson -Darling and
Pearson's chi -square (χ2) tests. Thereby, we used the
median (Me) and the first and third quartiles (Q1; Q3)
of the variation series for the descriptive statistics of
quantita tive data. The cross -tabulation and
nonparametric Pearson criterion χ 2 were used to
compare the categorical variab les. The value p<0.05
was considered plausible in all cases of statistical
evaluation.
Results and their discussion
The maximum corrected visu al acuity before the
surgery ranged fr om 0.01 to 0.9 and amounted in
average to 0.174±0.012. The central, paracent ral or
absolute scotomas were found in 97 eyes (31.09 %).
The patients prior to surgery have demonstrated the
following DMP signs: microaneury sms and
microhemorrhages in the macula r region, intraretinal
microvascular abnormalities (IRMA), depositions of
solid exudates, and macular edema of different levels
of manifestation with cystic cavities. The mean retinal
thickness ranged from 195 μm to 88 0 μm and averaged
358.09±6.96 μm.
All the surgeries were fully performed. The
intraoperative complications include d
microhemorrhages after ILM removal in 6 -7 % of
cases, which resolved without additional treatment
during the first two days after the surger y. Partial
hemophthalmos has determined in 2 -3 % of cases by
the time vitrectomy was completed. Its distribution w as
blocked by the tamponade of the vitreous cavity with
perfluororganic compounds (DK -Line) and by
increasing the irrigation parameters to 40. 0 mm Hg.
Upon bleeding control perfluororganic compounds
were eliminated and irrigation parameters were
normalized to 25.0 mm Hg. In all cases,
hemophthalmos regressed without additional treatment
within 2 -3 days.
The relapse rate overall amounted to 29.7 % (93
eyes) one year after surgery, so the effectiveness of
DMP surgical treatment amounted to 70.3 %. The
relapse s in postoperative period (Fig.1) occurred in
23.0 % (72 eyes) at the 1 st month of follow -up, at the

American Scientific Journal № ( 28) / 20 19 29

3rd month – in 18.2 % (57 eyes), at the 6 th month – in
10.2 % (32 eyes) and in 24.9 % (78 eyes) after one year
of follow –up.


Fig. 1. DMP relapse rate wit hin one year after surgical treatment (total) and during follow -up period (in 1, 3, 6
months and 1 year).

The overall relapse rate of DMP throughout all
observation in terms of surgical treatment method is
presented in Table 1 and (for demonstration o f ne gative
findings) in Figure 2.
Table 1
DISTRIBUTION OF PATI ENTS BY PRESENCE AND ABSENCE OF DMP RELA PSES IN TERMS OF
TREATMENT METHODS (B Y ALL GROUPS OF PATIEN TS)
Relapses
CSV CSV+ILM
peeling
CSV+ILM
peeling+PRLC
CSV+ILM
peeling+PRLC+PHACO χ2 p
n=78 n=85 n=81 n=69
presence 25
32.1%
23
27.1%
23
28.4%
22
31.9% 0.714 0.870
absence 53
67.9%
62
72.9%
58
71.6%
47
68.1%
Notes: n – total number of patients with the applied method of treatment; χ 2 – Pearson criterion; p – probability
of diff erences in comparisons between groups.

The incidence of complications out of total
number of patients who underwent CSV amounted to
32.1% (25 eye s), CSV and ILM peeling – 27.1% (23
eyes), CSV, ILM peeling and PRLC – 28.4 % (23 eyes)
and CSV, ILM peeling, PRLC and PHACO – 31,9%
(22 eyes). The effectiveness of the applied methods
respectively amounted to: CSV – 67.9 %, CSV + ILM
peeling – 72.9 %, C SV + ILM peeling + PRLC
– 71.6 %, CSV + ILM peeling + PRLC + PHACO
– 68.1 %. These differences, however, were not
statisticall y significant (p=0.87).

0%
5%
10%
15%
20%
25%
30%
35%
1 month 3 months 6 months 1 year Total

30 American Sci entific Journal № ( 28) / 20 19
Fig. 2. DMP relapse rate in terms of the surgical treatment method within one year after surgical treatment;
χ2=0.714; р=0.870

The relapse rate in terms of treatment methods at
different follow -up periods (Table 2) did not dif fer
significantly from the general trend (see Fig. 1). The
relapses were more frequent solely after 1 month after
surg ery in those patients who underwent the maximum
amount of different surgeries (CSV, ILM peeling,
PRLC, and PHACO): 31.9 % (p=0.025). The m inimum
number of relapses was observed after CSV, ILM
peeling and PRLC after 1 and 3 months follow -up
period (14.8 % e ach); relapse rates by treatment
methods were not generally different 6 months and 1
year after surgery.
Table 2
DMP RELAPSE RATE BY TREA TME NT METHODS IN FOLLOW -UP CONTROL (FOR ALL
GROUPS OF PATIENTS)
Follow -up
period CSV CSV+ILM
peeling
CSV+ILM
peeling+P RLC
CSV+ILM
peeling+PRLC+PHACO χ2 p
1
month
n=78 n=85 n=81 n=69
9.367 0.025 22
28.2%
15
17.6%
12
14.8%
22
31.9%
3
months
n=78 n=85 n=8 1 n=69
1.276 0.735 15
19.2%
15
17.6%
12
14.8%
15
21.7%
6
months
n=78 n=85 n=81 n=65
0.038 0.998 8
10.3%
9
10.6%
8
9.9%
7
10.8%
1 year
n=78 n=85 n=78 n=65
0.179 0.981 19
24.4%
21
24.7%
21
26.9%
17
26.2%
Notes: n – total number of patients with the applied method of treatment; χ 2 – Pearson criterion; p – probability
of differences in comparisons between groups.

Late relapses occurring 6 months and 1 year after
surgery are considered to be the most dangerous ones,
as they are persistent and c an no longer be corrected by
further su rgeries [1 -3]. Early relapses tend to disappear,
i.e. they are transient.
The distribution of DMP relapses after surgical
treatment depending on their occurrence was observed
in the our study (Table 3). All relapses w ere divided
into three types: early tra nsient – those that occurred at
1-3 months and subsequently disappeared; early
persistent – those that occurred at 1 -3 months and then
remained for 6 months and 1 year; late – those that
occurred after 6 months and 1 year.
0%
5%
10%
15%
20%
25%
30%
35%
CSV CSV + ILM peeling CSV+ ILM
peeling+PRLC
CSV+ILM
peeling+PRLC+
PHACO

American Scientific Journal № ( 28) / 20 19 31

Table 3
DMP RELAPSE RATE BY TREATMENT METHODS IN TERMS OF THEIR PERIOD OF
OCCURRENCE
Relapses by
type
CSV CSV+ILM
peeling
CSV+ILM
peeling+PRLC
CSV+ILM
peeling+PRLC+PHACO χ2 p
n=78 n=85 n=81 n=69
Early
transient
5
6.4%
2
2.4%
1
1.2%
5
7.3% 5.0 81 0.166
Early
persistent
20
25.6%
14
16.5%
13
16.1%
17
24.6% 3.828 0.281
Late 0
0.0%
7
8.2%
9
11.1%
0
0.0% 15.639 0.001
χ2; р χ2=22.091; p=0.001
Notes: n – total number of patients with the applied method of treatment; χ 2 – Pearson criterion; p – prob abi lity
of differences in comparisons between groups.

Such type of analysis demonstrated some
differences between the applied methods of DMP
surgical treatment. Thus, the early persistent relapses
were the most frequent ones, which depending on
different met hods of treatment ranged from 16.1 % to
25.6 %. The patients who underwent CSV and
combination of CSV, ILM peeling, PRLC and PHACO
did not have any late complications. In the latter case,
the difference between the groups w as statistically
significant (p=0 .001).
Thus, after CVS and also when the combination of
CSV, ILM peeling, PRLC and PHACO was used, all
relapses experienced by the patients were early, the
majority of them (77.3 and 80.0 % respectively) were
persistent. Af ter CSV with ILM peeling and also when
the combination of CSV, ILM peeling and PRLC was
used, the majority of relapses were classified as early
persistent and late ones (91.3 % and 95.7 %
respectively), and thus had the unfavorable character.
This study in cluded the patients with DMP, whi ch
occurred due to DRP of different severity. So, we have
separately analyzed the distribution of relapse rate by
groups of patients (Table 4 and Fig. 3).
Table 4
DISTRIBUTION OF PATI ENTS BY THE PRESENCE AND ABSENCE OF DMP RELAPSES BY
GROUPS OF PATIEN TS (B Y ALL TREATMENT METH ODS)
Relapses
Group 1 Group 2 Group 3
χ2 p
n=40 n=92 n=181
presence 11
27.5%
21
22.8%
61
33.7% 3.433 0.180
absence 29
72.5%
71
77.2%
120
66.3%
Notes: n – total number of patients in groups; χ 2 – Pearson criterion; p – probability of differences in
comparisons between groups.

The rel apse rate within 1 year amounted to: group
1 – 27.5 % (11 eyes), group 2 – 22.8 % (21 eyes), and
group 3 – 33.7 % (61 eyes). This indicated that the
relap se rate depended on the severity of DRP as more
relapses were observed in PDR. However, it should be
noted that the overall analysis did not show any
statistically significant difference (p=0.180), so more
thorough analysis was required. Therefore, in gene ral,
the effectiveness of DMP surgical treatment amounts to
72.5 % in primary NPDR; 77.2 % in moderate and
severe NPDR, and 66.3 % in PDR. In our opinion, such
result could not be considered the final one and required
a more detailed research.

32 American Sci entific Journal № ( 28) / 20 19
Fig. 3. DM P relapse rate within 1 year after surgical treatment by groups of patients; χ 2=3.433; р=0.18

Thus, the relapse rate analysis in groups of patients
(Table 5) by the follow -up periods has indicated that
group 3 is characterized by maximum relapse number
(32.2 %), which was statistically significant after 1 year
at the level of p=0.008.
Table 5
DMP RELAP SE R ATE BY GROUPS OF PAT IENTS (BY ALL TREATMENT ME THODS)
Follow -up
period Group 1 Group 2 Group 3 χ2 p
1
month
n=40 n=92 n=181
0.467 0.792 9
22.5%
19
20.7%
44
24.3%
3
months
n=40 n=92 n=181
4.363 0.113 5
12.5%
12
13.0%
40
22.1%
6
months
n=40 n=92 n=177
5.467 0.065 0
0.0%
10
10.9%
22
12.4%
1 year
n=40 n=92 n=174
9.537 0.008 7
17.5%
15
16.3%
56
32.2%
Notes: n – total number of patients in groups; χ 2 – Pearson criterion; p – probability of differences in
comparisons between groups.

The relapse rate in group 3 was 1.7 times bigger
than in of both groups 1 and 2 after 3 months. On the
whole, the patients of group 1 did not experie nce any
relapses after 6 months. The relapse rate in group 3
again was 1.8 and 2.0 times higher than in groups 1 and
2 respectively after 1 year (p=0.008).
The distribution by relapse type was as follows
(Table 6). Early persistent complications were
preva lent in all groups, ranging from 54.5 % in group 1
to 72.1 % in group 3 (% out of the number of
complications in the group). However, the early
transient complications were more common among the
other complicat ions in the 1 st group (36.4 %), while the
late complications — in the 3 rd group (21.3 %).
0%
5%
10%
15%
20%
25%
30%
35%
Group 1 Group 2 Group 3

American Scientific Journal № ( 28) / 20 19 33

Table 6
DMP RELAPSE RATE BY GROUPS OF PATIENTS I N TERMS OF THEIR PERIOD OF
OCCURRENCE
Relapses by
type
Group 1 Group 2 Group 3
χ2 p
n=11 n=21 n=61
Early
transi ent
4
36.4%
5
23.8%
4
6.6% 5.531 0.063
Early
persistent
6
54.5%
14
66.7%
44
72.1% 3.936 0.140
Late 1
9.1%
2
9.5%
13
21.3% 15.639 0.001
χ2; р χ2=9.974; p=0.041
Notes: n – total number of patients in groups; χ 2 – Pearson criterion; p – probability of dif fer ences in
comparisons between groups.

Thus, group 3 was not only characterized by the
big number of relapses but by their severity as well, and
absolute majority of such cases (93.4%) consisted of
early persistent and late relapses. The number of late
rela pses in patients of group 3 was 2.3 times bigger than
in groups 1 and 2 (p=0.001). Therefore, the patients
with PDR demonstrated both a higher relapse rate and
a greater relapse severity in DMP surgical treatment,
and, thus, the effectiveness of surgic al i nterventions in
DMP treatment was lower in cases with PDR, which
was especially true for persistent and late relapses.
The analysis of how the treatment methods
influence the relapse rate of DMP in group s of patients
for all follow -up periods (after 1, 3, 6 months and 1
year) indicated that the difference in number of DMP
relapses in different methods of surgical treatment was
not statistically significant (p>0.7) for any of the
follow -up periods. This ag ain confirms the similar
effectiveness of DMP tre atme nt methods that have
been applied. Instead, the effectiveness of DMP
treatment clearly depended on the severity of DRP.
Thus, the number of relapses in patients of group 1
during the follow -up period of all treatment methods
ranged from 0 % to 16.7 %, in p atients of group 2
– from 13.3 % to 37.5 %, whereas in patients of group
3 – from 50.0 % to 86.7 %. Hence, the effectiveness of
DMP surgical treatment clearly depends on primary
severity of DRP, as it is the most severe in cases with
PDR.
Conclusions
1. Th e effectiveness of DMP surgical treatment
amounted to 70.3 %; relapses occurred in 23.0 % of
cases at the 1 st month of follow -up, at the 3 rd month —
in 18.2 %, at the 6 th month — in 10.2 % and after 1 ye ar
— in 24.9 % of cases.
2. The effectiveness of mode rn surgical methods
of DMP treatment of the patients with T2D amounted
to: CSV – 67.9 %, CSV + ILM peeling – 72.9 %, CSV
+ ILM peeling + PRLC – 71.6 %, CSV + ILM peeling
+ PRLC + PHACO – 68.1 %. These d ifferences were
not statistically significant (p= 0.87 ).
3. The relapse rate in treatment methods at
different follow -up periods did not differ significantly.
The patients who underwent combined methods of
surgical treatment (CSV with ILM peeling, PRLC with
ILM peeling, PRLC with PHACO) experienced more
frequ ent relapses after 1 month – 31.9 % (p=0.025).
3. After CSV only, as well as after the combined
application of all surgical interventions (CSV, ILM
peeling, PRLC, PHACO) all the relapses were early,
and the majority of them (77.3 and 80.0 % respectivel y)
were persistent. In other variants of surgical
intervention the majority of relapses (91 -96 %) were
determined as the early persistent and late ones.
4. The effectiveness of DMP surgical treatm ent
has been reducing by the retinopathy progression and
amo unts to 72.5 % in primary NPDR; 77.2 % in
moderate and severe NPDR and 66.3% in PDR. The
patients with PDR demonstrated both a higher relapse
rate (33.7 %) and a higher relapse severity (a number of
late relapses in patients in group 3 was 2.3 times greate r
than in the patients of groups 1 and 2; p=0.001).

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