Saudi Journal of Ophthalmology (2014) 28, 292298Original ArticleComparison between sutureless and glue free versus suturedlimbal conjunctival autograft in primary pterygium surgeryPeer review under responsibilityof Saudi Ophthalmological Society,King Saud University Production and hosting by Elsevier

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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.comShaaban A.M. Elwan, MD AbstractPurpose: 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 2474 years). Simple excision under local anesthesia was performed followed by closure of the bare sclera by suture less and glue freeconjunctival autograft in 50 eyes of 50 patients (group 1), versus the conventional method of a sutured conjunctival autograft in 100eyes 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 versus6 eyes (6%) in group 2. Pyogenic granuloma occurred in 3 (3%) eyes out of 100 in group 2. No other serious complications werenoted. At the 3 week visit the overall patient satisfaction score was statistically significantly higher for group 1 (P < 0.002) com-pared to group 2. At 3 months postoperatively, the gain in uncorrected visual acuity (UCVA) ranged from 0.2 to 0.5 Log MARin 10 eyes.Conclusion: Sutureless and glue free conjunctival autograft technique is easy, safe, effective, prevents potential adverse reactionsencountered with the use of foreign materials. This technique has an acceptable pterygium recurrence rate that is comparable toconventional 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.2014.03.012Introduction

Pterygium (derived from pterygion, ancient Greek forwing) is a common ocular disease seen mostly in tropicaland subtropical areas between the latitudes 30 north andsouth of the equator.1,2 Pterygium is an abnormal over-growth of fibrovascular tissue arising from the subconjunctivatoward the cornea, almost always in the palpebral fissure andthought to be caused by increased light exposure, dust,dryness, heat and wind. Although it can be easily excised, ithas a high rate of recurrence ranging from 24% to 89%.3

Recently, with the popularity of conjunctival autograft anduse of antimetabolites such as mitomycin C and 5-Fluoroura-cil the incidence of recurrence has been greatly reduced upto 12%.46 The role of carbon dioxide and eximer lasers inpterygium surgery remains uncertain. Additionally, the rela-tive benefits and risks are debatable of physiochemical meth-ods to prevent recurrence. For example possiblee:al.com

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Primary pterygium surgery 293complications of mitomycin C and beta-irradiation includeaseptic necrosis of the sclera and cornea, cataract, persistentepithelial defects and visual loss.7

Therefore, a simple surgical procedure that can reduce therecurrence rate to an acceptable level with minimal complica-tions and without the use of potentially toxic drugs or radio-therapy would be ideal for the management of pterygium.Recent reports favor the use of fibrin glue above sutures.The use of fibrin glue has been reported to improve comfort,decrease surgical time, reduce complications and recurrencerates.811 Suture-related complications include infection, pro-longed operating time, postoperative discomfort, sutureabscesses, buttonholes, and pyogenic granuloma which usu-ally require a second surgery for removal and chronic inflam-mation,12,13 Plasma-derived fibrin glue has the potential riskof prion disease transmission and anaphylaxis in susceptibleindividuals.

Sutureless grafting has been used successfully in gingivalgrafts,14 and represents a similar mucosal membrane tissueenvironment to the conjunctiva of the eye. In this study, wecompare and evaluate the safety and efficacy of suturelessglue free limbal conjunctival autograft and conventionalsutured autograft for the management of primary pterygium.Material and methods

The study sample was comprised of 150 eyes of 150patients with primary pterygium. The patients complainedof conjunctival injection, tearing, rapid growth with cosmeticconcerns, and encroachment of the pupillary area threaten-ing the visual axis or blurred vision from induced astigmatism(Fig. 1). Exclusion criteria were inability to complete the twoyear follow up period, atrophic pterygium, pseudopteryg-ium, ocular surface pathology, infection, previous limbal sur-gery or double head pterygium. The study adhered to thetenets of the Declaration of Helsinki for research in humansand informed written consent was obtained from all patients.

All patients underwent a comprehensive ophthalmologicexamination including visual acuity, refraction, slit lamp bio-microscopy, measurement of intraocular pressure, extraocu-lar muscle movements and dilated funduscopy. AnteriorFigure 1. A case of pre-operative primary right nasal pterygium.segment photography was performed for documentation ofpterygium size and morphology.

The patients were randomly assigned into one of twogroups: group 1 underwent sutureless and glue free limbalconjunctival autograft (n = 50 eyes) and group 2 underwentfree limbal conjunctival autograft with suturing, (n = 100 eyes).The technique used in our study is simple randomization tech-nique.15 This technique maintains complete randomization ofpatient assignment to a particular group. The most commonand basic method of simple randomization is a coin toss. Forexample, with the two treatment groups (group 1 versusgroup 2), each side of the coin determines the assignment ofeach patient to a group. The goals of pterygium surgery wereto remove the pterygium, restore the conjunctival anatomy,leave the cornea as smooth and clear as possible, and preventrecurrence. Simple pterygium excision was performed underperibulbar anesthesia (Xylocaine 2%). After an eyelid specu-lum was inserted, a traction suture (60 Vicryl on a spatulatedneedle) was placed proximal to the limbus at the 6-oclockposition. Hand held cautery was used to outline the edgeof the pterygium to be excised usually 4 mm from the limbus.Local anesthesia was used to balloon the pterygium separat-ing it from the sclera. Excision consisted of detachment ofthe pterygium head using a crescent knife and dissection ofthe body from the overlying conjunctiva in a smooth clearplane as possible using blunt and sharp dissection. Subse-quently, the subconjuctival pterygium tissue and the thick-ened segment of conjunctiva and adjacent Tenons capsulewere excised leaving bare sclera. Then the size of bare scleralwas measured with calipers and the area documented in mm2.

For harvesting the conjunctival autograft, the globe isrotated upward with a limbal traction suture. The inferiortemporal quadrant of bulbar conjunctiva was injected with1 cc of local anesthesia (Xylocaine 2%) to facilitate separationof the conjunctiva from Tenons capsule then, a marker wasused to mark the four corners of the conjunctival limbal graftto be created 2 mm larger in width and length than the reci-pient bed. A small opening was created and careful blunt dis-section with Wescott scissors was performed until the entiregraft was free from Tenons reaching the limbus to includelimbal stem cells that act as a barrier to the conjunctival cellsmigrating onto the corneal surface. Subsequently, the edgesof the graft were cut by Vannas scissors. Forceps is used togently slide the graft to the recipient bed with the epithelialside up and keeping the limbal edge toward the limbus.

In group 1, hemostasis was allowed to occur spontaneouslywithout use of cautery to provide autologous fibrin to glue theconjunctival autograft naturally in position without tensionand the scleral bed was viewed through the transparent con-junctiva to ensure that residual bleeding did not lift the graft.Small central hemorrhages were tamponed with direct com-pression. The graft was held in position for 10 min by applica-tion of gentle pressure over the graft with fine non-toothedforceps. The stabilization of the graft was tested with a Mero-cel spear centrally and on each free edge to ensure firmadherence to the sclera. The eye was bandaged for 48 h.

In group 2, the graft was sutured in position with 10/0nylon. First the two limbal corners were sutured into the epi-sclera and then into the conjunctiva keeping the limbal edgeof the graft on gentle stretch then the posterior corners ofthe graft were sutured to the bulbar conjunctiva and addi-tional sutures were placed to close the wound edges. Both

Table 1. Clinical data.

Group 1N = (50 eyes)

Group 2N = (100 eyes)

Pvalue

Range of age in(years) & mean, SD

267450. 08 (12.76)

247249.08 (10.65)

0.78

SexMale 30 70Female 20 30

LateralityRight 20 65Left 30 35

Size of pterygium in mmlength (mean) & SD

4.398 (1.534) 4.178 (1.432) 0.286

Figure 2. A case of post-operative sutureless and glue free conjunctivallimbal autograft in place.

294 S.A.M. Elwangroups received subconjunctival injection of corticosteroidand antibiotic at the end of the procedure.

Post-operatively a pressure eye patch was applied.Analgesia was prescribed two times daily. Post-opersativemedication included Predforte eye drops (Allergan Inc.,Irvine, CA, USA) four times daily, Tobradex ointment (AlconInc., Fort Worth, TX, USA) three times daily was used for1 week then gradual tapering for 3 weeks and liberal use oftopical lubricating eye drops four times daily for 4 weeks.The patients were instructed to avoid rubbing their eyesand avoid dust, heat, direct sun exposure. The patients werealso advised to wear sun glasses to reduce UVB exposure.

All patients were followed up after 48 h, weekly for onemonth 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, foreignbody (F.B) sensation, photophobia, hyperemia and chemosisinto four grades according to the intensity. The questionnairewas scored from (0 to 3) 0 = nothing; 1 = mild; 2 = moderate;3 = severe. Additionally, the overall satisfaction with the pro-cedure 3 weeks post-operatively was recorded as four grades0 = unsatisfied; 1 = low satisfaction; 2 = moderate satisfac-tion and; 3 = highly satisfied. The data were collected asmean scores and recorded. The two groups were comparedfor ocular signs and symptoms, and overall satisfaction.

The main postoperative outcomes noted were the recur-rence rate which was defined as fibrovascular proliferationinvading the cornea more than 1.5 mm at the site of previ-ously excised pterygium, graft dehiscence, graft retractionand the gain in uncorrected visual acuity (UCVA). The second-ary outcomes were duration of surgery, postoperative pain,foreign body sensation, photophobia, hyperemia, chemosis,overall satisfaction and the complications as, persistent epi-thelial defect, dellen, inclusion cyst, pyogenic granuloma,conjunctival edema, corneo-scleral necrosis, infective scleri-tis, keratitis and endophthalmitis.Statistical analysis

Data are expressed as mean SD. Snellen acuity was con-verted to Log MAR for statistical analysis. Statistical analysiswas performed using one-way ANOVA. SPSS 16 for Windows(IBM Corp., New York, NY, USA) was used for statistical anal-ysis. P-values less than 0.05 were considered statisticallysignificant.Figure 3. A case of post-operative conventional sutured conjunctivallimbal autograft by Nylon 10/0.Results

The pterygia were located nasally in all eyes for bothgroups. Patient age in both groups ranged from 24 to74 years (mean, 49 12 years) (Table 1). There were 100males and 50 females enrolled in this study. In 85 eyes, ptery-gia were present in the right eye and 65 in the left eye. (Figs. 2and 3 present the data for group 1 and group 2, respec-tively). There was no statistically difference in age betweengroups (P > 0.05). The two groups were clinically similarregarding the size of the pterygium.

Table 2 presents the main and secondary postoperativeoutcomes. 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 ofrecurrence in group 2 occurred after 6 months. Graft dehis-cence occurred in 8% (4 eyes) in group 1 and there wereno cases of graft dehiscence in group 2. In one patient graftdehiscence developed with eye trauma on the third post-operative day. In another patient it occurred following vigor-ous rubbing of the eye on the fourth postoperative day. Intwo patients it occurred due to inclusion of Tenons capsuleleading to lack of adhesion, graft edema and thickening,

Table 2. Showing postoperative main and secondary outcomes.

Group 1 N = (50eyes)

Group 2 N = (100eyes)

Recurrence rate 3 (6%) 8 (8%)Graft dehiscence 4 (8%) 0 (0%)Early graft retraction 6 (12%) 6 (6%)Gain in UCVA 4 (8%) 6 (6%)Conjunctival edema 8 (16%) 6 (6%)Conjunctival granuloma 0 (0%) 3 (3%)Corneal scar (faint nebula) 2 (4%) 4 (4%)Dellen 0 (0%) 1 (1%)Operative time in minutes

(mean, SD)24 (5.64) 28.64 (6.45)

Conjunctival cyst 0 (0%) 1 (1%)Graft necrosis 0 (0%) 0 (0%)Symblepharon 0 (0%) 0 (0%)Scleral necrosis 0 (0%) 0 (0%)Scleral thinning 0 (0%) 0 (0%)

Figure 4. A case of post-operative pyogenic granuloma reported ingroup 2.

Primary pterygium surgery 295which was seen on the fifth post-operative day in one patientand the seventh post-operative day in the other patient. Allfour patients were treated by suturing the same graft with(10/0 nylon sutures).

Early graft retraction with exposure of scleral bedoccurred in 6 eyes (12%) in group 1 and in 6 eyes (6%) ingroup 2 within the first postoperative week due to conjuncti-val edema and chemosis. All cases were resolved with conser-vative management except one patient from group 1 whowas managed with (10/0 nylon) sutures.

The gain in uncorrected visual acuity (UCVA) occurred3 months post operatively and ranged from 0.2 to 0.5 LogMAR in 10 eyes. Four eyes (8%) were from group 1 and 6 eyes(6%) were in group 2. All cases with a gain in UCVA were dueto clearance of visual axis occupied by pterygium pre-operatively.

Conjunctival edema occurred in 8 eyes (16%) in group 1and in 6 eyes (6%) in group 2. Most cases of conjunctivaledema resolved gradually within the first post-operativeweek. Faint corneal nebula occurred in two eyes (4%) ingroup 1 and in 4 eyes (4%) in group 2. Conjunctival granu-loma (Fig. 4) occurred only in group 2 in three eyes (3%),two of them treated by surgical excision within the firstpost-operative month and the other one resolved by conser-vative management. Conjunctival cyst and dellen each ofthem occurred in one eye (1%) in group 2. There are no anes-thetic complications, graft necrosis, symblepharon, scleralnecrosis or thinning, excessive bleeding, globe perforationor injury to medial rectus in all of patient groups.

Figs. 5AB and 6AB show a clinically significant differ-ence between groups in the postoperative mean score forsigns and symptoms on visits day 3, 1 week, 2 weeks and3 weeks post-operatively. The mean scores were statisticallysignificant lower for group 1 for each factor graded(P < 0.05). At 3 weeks post-operatively, the mean overallpatients satisfaction score was significantly higher for thegroup 1 (P < 0.002).Discussion

Surgical techniques for the management of pterygiumvary, but high recurrence rates after successful excisionremain a challenge. The aim of pterygium surgery is to excisethe pterygium and prevent its recurrence. However, there arevery few clinical guidelines for optimal treatment that lowerrecurrence and complication rates. The variety of techniques,range from the bare sclera procedure to more complexapproaches, such as amniotic membrane transplantationand lamellar keratoplasty, including conjunctival autograft,and limbal conjunctival transplant, conjunctival flap, conjunc-tival rotation autograft surgery, cultivated conjunctival trans-plant (ex-vivo expanded conjunctival epithelial sheet) and useof fibrin glue. Adjunctive therapies include Beta irradiation,Thiotepa, 5-Fluorouracil, Daunorubicin, and mitomycin C(MMC).1619

Bare sclera excision (BSE) has an unacceptably high recur-rence rate (4060%) and has become obsolete. BSE with per-ioperative MMC,2022 preoperative subconjunctival injection,intraoperative application and postoperative drops hadyielded better outcomes, but the risk of complications hasmade this procedure less favorable. BSE with beta irradia-tion,23 has resulted in encouraging outcomes (13% recur-rence); however it has toxic and serious complications.

Pterygium excision with limbal conjunctival autograft,24

has been reported to be more effective with low recurrencebut it may compromise the corneal stem cell population.Additionally, adjunctive use of amniotic membrane graftresults in low recurrence but costly.21,25

Fibrin glue has been used as an alternative to sutures forsecuring the conjunctival grafts.10A study has reported recur-rence rate of 5.3% for glue versus 13.5% for sutures and sug-gested that immediate adherence of the graft and lack ofpostoperative inflammation may inhibit fibroblast ingrowthand reduce the recurrence.10 The main issue in using com-mercial fibrin glue, despite viral inactivation techniques, isthe transmission of infectious agents such as parvovirus B19(HPV B19) and prions.26 Furthermore, anaphylactic reactionhas been reported after the use of (TISSEEL) fibrin sealantwhich was due to bovine protein aprotinin.27 Foroutan et al.26

prepared autologous fibrin glue, though much safer but it isnot yet used widely because of the duration it takes to pro-cure the fibrin and lack of laboratory facilities at all centers.Fibrinogen compounds may be susceptible to inactivationby iodine preparations used for conjunctival disinfectionbefore pterygium surgery.28

Figure 5. Postoperative signs and symptoms in Group 1 and Group 2 on day 3 (A) and at one week (B).

0

10

20

30

40

50

60

Pain F B. Sensaon Photophobin Hyperemia Chemosis

Group 1

Group 2

Week 2 Postoperave Signs &Symtoms

Mea

n Sc

ore

P

Primary pterygium surgery 2976 eyes (6%) in group 2. All the cases of graft retraction weredue to conjunctival chemosis and edema and were resolvedwith conservative treatment except one case in group 1which progressed to graft dehiscence and was sutured with10/0 nylon. In comparison, Wit et al.28 reported no graft dis-placement and postulated that sutureless and glue free graftresulted in even tension across the whole graft interface andno direct tension on the free edges resulting in reduced stim-ulus for sub-conjunctival scar formation. Wit et al.28 also pro-posed that the apposition of the eye lids to the bulbarconjunctiva provides a natural biological dressing, compres-sion, and a smooth frictionless surface.

Pyogenic granuloma occurred in 3 eyes out of 100 (3%)eyes in group 2 and did not occur in group 1, cyst formationoccurred in one eye (1%) in group 2 and dellen also occurredin one eye (1%) in group 2. These outcomes indicate thatcomplications related to sutures are more common in group2 despite using 10/0 nylon which induces minimal reactionand were removed after 2 weeks with some discomfort andforeign body sensation post-operatively. WE noted thatsome patients were not co-operative at the slit lamp duringsuture removal.

Conjuctival edema occurred in our study in 8 eyes (16%) ingroup 1 and (6%) in group 2, using interrupted 10/0 nylonsuture in group 2 which allows for any fluid build up to escapethrough the intervening spaces rather than precipitating aminimal reaction. Most of the cases resolved spontaneouslywith conservative treatment.

The mean operative time in group 1 was 24 (5.64) minand 28.64 (6.45) min in group 2. These times are compara-ble however they are longer than other studies33,28 usingfibrin glue which reported average operative time of 16 min(range 1416) and 20 min (range 2029) in suture groupand reported 14 (1.4) min in suture-less and glue free con-junctival autograft. Although our study was conducted overa two-year duration, we believe it was worthwhile to providethe patients with the benefits of suture-less and glue freeconjunctival limbal autograft.

Our results confirmed significantly lower post-operativesigns and symptoms including pain, FB sensation, photopho-bia, hyperemia and chemosis at all visits in the first post-oper-ative month as well as significantly higher overall patientsatisfaction in group 1 compared to group 2. None of ourpatients developed serious complications such as scleralnecrosis, sclera thinning, graft necrosis, symblepharon,excessive bleeding, medial rectus muscle injury, or globeperforation.Conclusion

Suture-less and glue free limbal conjunctival autograft issafe, effective, economical, and its surgical outcomesfollowing primary pterygium surgery are comparable toconventional suture limbal conjunctival autograft with lowerpost-operative suture related complications, less patientdiscomfort and greater patient satisfaction.Conflict of interest

The authors declared that there is no conflict of interest.References

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Comparison between sutureless and glue free versus sutured limbal conjunctival autograft in primary pterygium surgeryIntroductionMaterial and methodsStatistical analysis

ResultsDiscussionConclusionConflict of interestReferences