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Original Article
Abstract
Purpose: To compare and evaluate the safety and efficacy of two surgical techniques for the management of primary pterygium.
Design: Prospective randomized clinical trial using the CONSORT 2010 Statement (Consolidated Standards of Reporting Trials)
for parallel group randomized trials.
Setting: Department of Ophthalmology, Al-Minya University, Faculty of Medicine, Egypt.
Methods: The study included 150 eyes of 150 patients with primary pterygium. The mean age was 49 12 years (range 24
74 years). Simple excision under local anesthesia was performed followed by closure of the bare sclera by suture less and glue free
conjunctival autograft in 50 eyes of 50 patients (group 1), versus the conventional method of a sutured conjunctival autograft in 100
eyes of 100 patients (group 2).
Results: The pterygium recurrence rate was 6% for group 1, 8% for group 2.
Graft dehiscence occurred in 4 eyes out of 50 (8%) in group 1. Graft retraction occurred in 6 (12%) out of 50 eyes for group 1 versus
6 eyes (6%) in group 2. Pyogenic granuloma occurred in 3 (3%) eyes out of 100 in group 2. No other serious complications were
noted. At the 3 week visit the overall patient satisfaction score was statistically significantly higher for group 1 (P < 0.002) compared to group 2. At 3 months postoperatively, the gain in uncorrected visual acuity (UCVA) ranged from 0.2 to 0.5 Log MAR
in 10 eyes.
Conclusion: Sutureless and glue free conjunctival autograft technique is easy, safe, effective, prevents potential adverse reactions
encountered with the use of foreign materials. This technique has an acceptable pterygium recurrence rate that is comparable to
conventional sutured conjunctival autograft for primary pterygium.
Keywords: Pterygium surgery, Sutureless glue free conjunctival autograft, Conjunctival autograft, Amniotic membrane graft
2014 Saudi Ophthalmological Society, King Saud University. Production and hosting by Elsevier B.V. All rights reserved.
http://dx.doi.org/10.1016/j.sjopt.2014.03.012
Introduction
Pterygium (derived from pterygion, ancient Greek for
wing) is a common ocular disease seen mostly in tropical
and subtropical areas between the latitudes 30 north and
south of the equator.1,2 Pterygium is an abnormal overgrowth of fibrovascular tissue arising from the subconjunctiva
toward the cornea, almost always in the palpebral fissure and
thought to be caused by increased light exposure, dust,
Received 26 November 2012; received in revised form 2 December 2013; accepted 20 March 2014; available online 29 March 2014.
Ophthalmology Department, Al-Minia University Hospitals, Faculty of medicine, Al-Minia University, Egypt.
Tel.: +966-509507738.
e-mail address: shaabanhamid@yahoo.com
Peer review under responsibility
of Saudi Ophthalmological Society,
King Saud University
293
segment photography was performed for documentation of
pterygium size and morphology.
The patients were randomly assigned into one of two
groups: group 1 underwent sutureless and glue free limbal
conjunctival autograft (n = 50 eyes) and group 2 underwent
free limbal conjunctival autograft with suturing, (n = 100 eyes).
The technique used in our study is simple randomization technique.15 This technique maintains complete randomization of
patient assignment to a particular group. The most common
and basic method of simple randomization is a coin toss. For
example, with the two treatment groups (group 1 versus
group 2), each side of the coin determines the assignment of
each patient to a group. The goals of pterygium surgery were
to remove the pterygium, restore the conjunctival anatomy,
leave the cornea as smooth and clear as possible, and prevent
recurrence. Simple pterygium excision was performed under
peribulbar anesthesia (Xylocaine 2%). After an eyelid speculum was inserted, a traction suture (60 Vicryl on a spatulated
needle) was placed proximal to the limbus at the 6-oclock
position. Hand held cautery was used to outline the edge
of the pterygium to be excised usually 4 mm from the limbus.
Local anesthesia was used to balloon the pterygium separating it from the sclera. Excision consisted of detachment of
the pterygium head using a crescent knife and dissection of
the body from the overlying conjunctiva in a smooth clear
plane as possible using blunt and sharp dissection. Subsequently, the subconjuctival pterygium tissue and the thickened segment of conjunctiva and adjacent Tenons capsule
were excised leaving bare sclera. Then the size of bare scleral
was measured with calipers and the area documented in mm2.
For harvesting the conjunctival autograft, the globe is
rotated upward with a limbal traction suture. The inferior
temporal quadrant of bulbar conjunctiva was injected with
1 cc of local anesthesia (Xylocaine 2%) to facilitate separation
of the conjunctiva from Tenons capsule then, a marker was
used to mark the four corners of the conjunctival limbal graft
to be created 2 mm larger in width and length than the recipient bed. A small opening was created and careful blunt dissection with Wescott scissors was performed until the entire
graft was free from Tenons reaching the limbus to include
limbal stem cells that act as a barrier to the conjunctival cells
migrating onto the corneal surface. Subsequently, the edges
of the graft were cut by Vannas scissors. Forceps is used to
gently slide the graft to the recipient bed with the epithelial
side up and keeping the limbal edge toward the limbus.
In group 1, hemostasis was allowed to occur spontaneously
without use of cautery to provide autologous fibrin to glue the
conjunctival autograft naturally in position without tension
and the scleral bed was viewed through the transparent conjunctiva to ensure that residual bleeding did not lift the graft.
Small central hemorrhages were tamponed with direct compression. The graft was held in position for 10 min by application of gentle pressure over the graft with fine non-toothed
forceps. The stabilization of the graft was tested with a Merocel spear centrally and on each free edge to ensure firm
adherence to the sclera. The eye was bandaged for 48 h.
In group 2, the graft was sutured in position with 10/0
nylon. First the two limbal corners were sutured into the episclera and then into the conjunctiva keeping the limbal edge
of the graft on gentle stretch then the posterior corners of
the graft were sutured to the bulbar conjunctiva and additional sutures were placed to close the wound edges. Both
294
groups received subconjunctival injection of corticosteroid
and antibiotic at the end of the procedure.
Post-operatively a pressure eye patch was applied.
Analgesia was prescribed two times daily. Post-opersative
medication included Predforte eye drops (Allergan Inc.,
Irvine, CA, USA) four times daily, Tobradex ointment (Alcon
Inc., Fort Worth, TX, USA) three times daily was used for
1 week then gradual tapering for 3 weeks and liberal use of
topical lubricating eye drops four times daily for 4 weeks.
The patients were instructed to avoid rubbing their eyes
and avoid dust, heat, direct sun exposure. The patients were
also advised to wear sun glasses to reduce UVB exposure.
All patients were followed up after 48 h, weekly for one
month then for 3, 6, 9, 12 and 24 months postoperatively.
Patients completed a questionnaire at each follow-up visit,
especially during the visits for the first post-operative month
(3 days, 1 week, 2 weeks and 3 weeks) grading pain, foreign
body (F.B) sensation, photophobia, hyperemia and chemosis
into four grades according to the intensity. The questionnaire
was scored from (0 to 3) 0 = nothing; 1 = mild; 2 = moderate;
3 = severe. Additionally, the overall satisfaction with the procedure 3 weeks post-operatively was recorded as four grades
0 = unsatisfied; 1 = low satisfaction; 2 = moderate satisfaction and; 3 = highly satisfied. The data were collected as
mean scores and recorded. The two groups were compared
for ocular signs and symptoms, and overall satisfaction.
The main postoperative outcomes noted were the recurrence rate which was defined as fibrovascular proliferation
invading the cornea more than 1.5 mm at the site of previously excised pterygium, graft dehiscence, graft retraction
and the gain in uncorrected visual acuity (UCVA). The secondary outcomes were duration of surgery, postoperative pain,
foreign body sensation, photophobia, hyperemia, chemosis,
overall satisfaction and the complications as, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma,
conjunctival edema, corneo-scleral necrosis, infective scleritis, keratitis and endophthalmitis.
S.A.M. Elwan
Table 1. Clinical data.
Group 1
N = (50 eyes)
Group 2
N = (100 eyes)
P
value
Range of age in
(years) & mean, SD
2674
50. 08 (12.76)
2472
49.08 (10.65)
0.78
Sex
Male
Female
30
20
70
30
Laterality
Right
Left
20
30
65
35
4.398 (1.534)
4.178 (1.432)
Size of pterygium in mm
length (mean) & SD
0.286
Statistical analysis
Data are expressed as mean SD. Snellen acuity was converted to Log MAR for statistical analysis. Statistical analysis
was performed using one-way ANOVA. SPSS 16 for Windows
(IBM Corp., New York, NY, USA) was used for statistical analysis. P-values less than 0.05 were considered statistically
significant.
Results
The pterygia were located nasally in all eyes for both
groups. Patient age in both groups ranged from 24 to
74 years (mean, 49 12 years) (Table 1). There were 100
males and 50 females enrolled in this study. In 85 eyes, pterygia were present in the right eye and 65 in the left eye. (Figs. 2
and 3 present the data for group 1 and group 2, respectively). There was no statistically difference in age between
groups (P > 0.05). The two groups were clinically similar
regarding the size of the pterygium.
Table 2 presents the main and secondary postoperative
outcomes. The recurrence rate was 6% (3 eyes) in group 1.
All cases of recurrence in group 1 occurred after 3 months.
The recurrence rate was 8% (8 eyes) in group 2. All cases of
recurrence in group 2 occurred after 6 months. Graft dehiscence occurred in 8% (4 eyes) in group 1 and there were
no cases of graft dehiscence in group 2. In one patient graft
dehiscence developed with eye trauma on the third postoperative day. In another patient it occurred following vigorous rubbing of the eye on the fourth postoperative day. In
two patients it occurred due to inclusion of Tenons capsule
leading to lack of adhesion, graft edema and thickening,
295
Recurrence rate
Graft dehiscence
Early graft retraction
Gain in UCVA
Conjunctival edema
Conjunctival granuloma
Corneal scar (faint nebula)
Dellen
Operative time in minutes
(mean, SD)
Conjunctival cyst
Graft necrosis
Symblepharon
Scleral necrosis
Scleral thinning
Group 1 N = (50
eyes)
Group 2 N = (100
eyes)
3 (6%)
4 (8%)
6 (12%)
4 (8%)
8 (16%)
0 (0%)
2 (4%)
0 (0%)
24 (5.64)
8 (8%)
0 (0%)
6 (6%)
6 (6%)
6 (6%)
3 (3%)
4 (4%)
1 (1%)
28.64 (6.45)
0
0
0
0
0
1
0
0
0
0
(0%)
(0%)
(0%)
(0%)
(0%)
(1%)
(0%)
(0%)
(0%)
(0%)
post-operative month and the other one resolved by conservative management. Conjunctival cyst and dellen each of
them occurred in one eye (1%) in group 2. There are no anesthetic complications, graft necrosis, symblepharon, scleral
necrosis or thinning, excessive bleeding, globe perforation
or injury to medial rectus in all of patient groups.
Figs. 5AB and 6AB show a clinically significant difference between groups in the postoperative mean score for
signs and symptoms on visits day 3, 1 week, 2 weeks and
3 weeks post-operatively. The mean scores were statistically
significant lower for group 1 for each factor graded
(P < 0.05). At 3 weeks post-operatively, the mean overall
patients satisfaction score was significantly higher for the
group 1 (P < 0.002).
Discussion
296
S.A.M. Elwan
Figure 5. Postoperative signs and symptoms in Group 1 and Group 2 on day 3 (A) and at one week (B).
P<0.001
Mean Score
50
40
P<0.001
P<0.003
30
P<0.001
Group 1
p<0.002
Group 2
20
10
0
Pain
Chemosis
P<0.002
Mean Score
160
140
120
100
Group 1
80
Group 2
60
40
20
P<0.001 P<0.001
P<0.003
P<0.003
P<0.001
0
Pain
F.B
Photophobia Hyperemia
Sensaon
Chemosis
Over All
Sasfacon
In our study we compared the two techniques of sutureless and glue free conjunctival limbal autograft (group1) with
the conventional sutured conjunctival limbal autograft
(group2) in primary pterygium surgery.
The recurrence rate (6%) in group 1 was comparable to
group 2 (8%). Massaoutis et al. 29 stated that the concept
of surgical success in pterygium surgery can be defined as
the provision of a white cosmetic conjunctiva, with no persistent symptoms and a low recurrence rate (less than 10%). The
recurrence rate in our study agrees with The Massaoutis
et al.s criteria. The recurrence rate is also similar to Malik
et al.30 who reported recurrence rate of 2.5% using a similar
procedure of sutureless and glue free graft.
Graft dehiscence is a recognized complication of techniques using glue.31,32 Froutan et al.26 reported 13.33% rate
of graft dehiscence using autologous fibrin and attributed
this to a low concentration of thrombin and fibrinogen in
autologous glue compared to a commercial preparation. In
our study graft dehiscence occurred in 4 eyes (8%) in group
1, and did not occur in group 2. The four cases in group 1,
were due to either eye trauma, or a patient rubbing his eye
vigorously and inclusion of Tenons capsule with the graft.
Hence, we instruct patients to use a protective shell and
not to rub the eye in the 1st week post-operatively. Additionally, meticulous dissections of thin donor limbal conjunctival
autograft free of Tenons capsule are mandatory for successful graft uptake.
Graft retraction was reported by Tan 13 who advocated
sub-conjuctival fibrosis and recommended meticulous dissection of sub-epithelial graft tissue. Foroutan et al.26 reported
20% of cases with graft retraction, in our study graft retraction occurred in 6 eyes out of 50 (12%) eyes in group 1 and
297
Conclusion
Suture-less and glue free limbal conjunctival autograft is
safe, effective, economical, and its surgical outcomes
following primary pterygium surgery are comparable to
conventional suture limbal conjunctival autograft with lower
post-operative suture related complications, less patient
discomfort and greater patient satisfaction.
Conflict of interest
The authors declared that there is no conflict of interest.
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