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 Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 23  |  Issue : 3  |  Page : 157-161

Double small incision lenticule extraction lenticular graft in impending corneal perforation


Department of Ophthalmology, Zagazig Faculty of Medicine, Zagazig, Egypt

Date of Submission07-Jan-2022
Date of Decision16-Feb-2022
Date of Acceptance16-Apr-2022
Date of Web Publication30-Jul-2022

Correspondence Address:
Sahar H Elsayed
Department of Ophthalmology, Zagazig University, Zagazig, Sharqya 44511
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/djo_1_22

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  Abstract 


Purpose The aim of this study was to evaluate the safety and efficacy of double stromal lenticules, extracted by femtolaser small incision lenticule extraction (SMILE) surgery, as a surgical adjuvant for sealing of impending corneal perforation.
Patients and methods The study included 20 eyes of 20 patients with impending corneal perforation. Double corneal stromal lenticules obtained through SMILE surgery, with a central thickness of 65 μm for each lenticule, were fixed over the corneal impending perforation site by 10-0 nylon interrupted stitches. The patients were monitored for a minimum of 6 months and were assessed using slit-lamp biomicroscopy, fluorescein stain, tonometry, and best spectacle-corrected visual acuity measurements. Postoperative complications were recorded throughout the follow-up period.
Results The mean age of the patients was 51.25±1.49 years. The mean thickness of the used double SMILE lenticules was 108.85±10.77 μm (range, 90–120 μm). The preoperative best spectacle-corrected visual acuity was counting fingers at 30 cm in four patients, whereas the other 16 patients had a visual acuity of hand movement. Postoperatively, the corneal perforations were successfully sealed in 16 (80%) patients, and 15 (75%) patients exhibited a statistically significant improvement in visual acuity (P=0.02). During the follow-up period of 6 months, there was evidence of one case of infection and two cases of sliding graft. There was no significant association between the patients’ data and the reported complications except the association between complications and hand movement visual acuity.
Conclusion The use of double corneal lenticules was a safe and effective surgical adjuvant for corneal perforation closure. It is a simple and inexpensive temporary measure to improve the corneal condition for further definitive interventions.

Keywords: corneal ulcer, impending perforation, lenticule graft, small incision lenticule extraction


How to cite this article:
Kotb AN, Elsayed SH. Double small incision lenticule extraction lenticular graft in impending corneal perforation. Delta J Ophthalmol 2022;23:157-61

How to cite this URL:
Kotb AN, Elsayed SH. Double small incision lenticule extraction lenticular graft in impending corneal perforation. Delta J Ophthalmol [serial online] 2022 [cited 2022 Dec 3];23:157-61. Available from: http://www.djo.eg.net/text.asp?2022/23/3/157/353030


  Introduction Top


Impending corneal perforation is an urgent condition caused by different types of infectious and noninfectious corneal disorders [1]. In the worst-case scenario, irreversible angle-closure glaucoma and microbial endophthalmitis can occur, which lead to blindness [2]. Surgical and/or nonsurgical interventions are sometimes required to close the perforation to reform the collapsed anterior chamber and to restore the visual function [3].

There are a variety of approaches for the management of corneal perforations, from nonsurgical treatments such as bandage soft contact lenses and tissue glues, to surgical modalities such as simple corneal suturing, conjunctival flaps, multilayered amniotic membrane transplantation (AMT), and tectonic corneal grafts [4],[5],[6]. The choice of the suitable treatment depends on the size and location of the perforation and the status of the underlying disease [7].

Small incision lenticule extraction (SMILE) is a refractive surgery procedure which involves passing a dissector through a small 2–3-mm incision to separate the lenticular interfaces and to allow the lenticule to be removed, thus eliminating the need to create a flap. The SMILE procedure is now gaining popularity following the results of the first prospective trials [8],[9],[10].

The aim of this study was to evaluate the clinical results of surgical management of impending corneal perforations using double stromal lenticule obtained from SMILE surgery.

[TAG:2]Patients and methods[TAG:]

This prospective interventional study was performed from September 2019 to November 2021 at Alpha Eye Hospital, Zagazig, Egypt. The study was approved by the Ethics Committee of Alpha Eye Hospital (IRB#:5/ 5 September 2019) and followed the World Medical Association’s ethical code for human experimentation, as stated in the Helsinki Declaration. It was carried out on 20 eyes of 20 patients with impending corneal perforation ([Figure 1]) treated by tectonic surgery using double corneal lenticules from femtolaser SMILE surgery. The patients who participated in the study signed a written informed consent that included the potential complications, the need for further interventions, willingness to participate in the study, and approval for publication of the data before enrollment in the study. All donors provided a written informed consent for lenticule donation. The donor tissues were collected in completely aseptic conditions.
Figure 1 Case of impending corneal perforation.

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Confirmation of impending corneal perforation was carried out by Seidel test with gentle pressure on the globe using sterile concentrated fluorescein staining. The best spectacle-corrected visual acuity (BSCVA) was assessed preoperatively. The corneal perforation size was recorded preoperatively by slit-lamp scale (it ranged from 1.5 to 3.5 mm) and was confirmed intraoperatively.

The donors were selected from SMILE patients with refractive correction spherical equivalent greater than 6 D, thus ensuring donor double lenticule central thickness of 65 μm each. All donors were negative for infections, corneal disease, human immunodeficiency virus, syphilis, hepatitis, and cancer. No donor had eye surgery beforehand. The main purpose of the treatment was to achieve the structural integrity of the globe.

Surgical technique

The corneal stromal lenticules were extracted during the SMILE procedure performed by a single ophthalmologist using a 500-kHz VisuMax Femtosecond Laser System (Carl Zeiss Meditec AG, Jena, Germany). The SMILE procedures were performed using a 65-μm cap thickness, 7.9-mm cap diameter, 6.0-mm optical zone of the lenticule, and 120° side-cut angle. All lenticules were immediately preserved in BSS (BSS TM ‹Balanced Salt Solution,’ Alcon Laboratories Inc., Fort Worth, Texas, USA) to be used during a 24-h duration.



All lenticule graft surgeries were performed by a single surgeon (A.N.K.) under peribulbar anesthesia [2% lignocaine hydrochloride (lidocaine hydrochloride 2%; Sunny Pharmaceutical, Badr City, Cairo, Egypt) and 0.75% bupivacaine (Sunnypivacaine, Bupivacaine HCL 100 mg/20 ml; Sunny Pharmaceutical) except one patient who preferred general anesthesia. The epithelial tissues were debrided by a sponge or a scalpel 1.0–2.0 mm around the impending perforation site. The double corneal lenticule was centered over the impending perforation with good alignment ([Figure 2]). Eight 10-0 nylon interrupted sutures were used to sew the lenticule to the healthy cornea around the perforation. The 12-o’clock and 6-o’clock sutures were taken first followed by the 3-o’clock and 9-o’clock sutures, followed by the remaining sutures ([Figure 3]). A bandage contact lens was applied at the end of the procedure ([Figure 4]).
Figure 2 Lenticule graft is in place.

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Figure 3 Eight stiches are taken.

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Figure 4 Immediate postoperative picture (contact lens in place).

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Postoperatively, topical steroid eye drops (1% prednisolone acetate, Pred forte; Allergan, Irvine, California, USA) were prescribed four times daily for 6 months. In addition, antibiotic eye drops (Vigamox eye drop; Alcon Laboratories Inc.) were administered four times daily for the first month. The patients were examined on days 1 and 7 and at 1, 3, and 6 months postoperatively ([Figure 5]). A slit-lamp biomicroscopy was performed to check the healing of the cornea on day 1. The following assessments were carried out on day 7 and afterwards including BSCVA and slit-lamp biomicroscopy. Any complications were recorded. Surgical success was defined as healing of the corneal ulcer or perforation and the survival of the corneal graft.
Figure 5 Six months postoperatively.

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Statistical analysis

The data collected throughout the study were analyzed using the Statistical Package for the Social Sciences (SPSS version 20.0; IBM, New York, New York, USA). Qualitative data were presented as number and percentage, whereas quantitative data were presented as mean±SD. The difference and association of qualitative variables were tested by the χ2 test, whereas the difference between quantitative independent variables was tested by Student t test. A P value less than 0.05 was considered statistically significant.

[TAG:2]Results[/TAG]

The mean age of patients was 51.25±1.49 years (range: 42–61 years). A total of eight patients were females and 12 were males. The mean thickness of the used SMILE double lenticule was 108.85±10.77 μm (range: 90–120 μm) ([Table 1]).
Table 1 Preoperative data

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The preoperative visual acuity was counting fingers (CF) at 30 cm in four patients, whereas the other 16 patients had a visual acuity of hand movement (HM). Postoperatively, there was a significant improvement in visual acuity, as five patients had a visual acuity of CF at 30 cm, four patients with CF at 50 cm, four patients with visual acuity of HM, three patients with visual acuity of CF at 1 m, two patients with CF at 2 m, and one patient with CF at 3 m, whereas only one patient lost vision to perception of light (P=0.02, [Table 2]).
Table 2 Preoperative and postoperative best spectacle-corrected visual acuity

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Postoperatively, the perforation was sealed in 16 (80%) patients, whereas leak occurred in four (20%) eyes and loose stitch occurred in one (5%) eye, which required re-suturing. The graft slid in two cases, whereas one eye had progressive infection ([Table 3]).
Table 3 Postoperative complications

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There was no significant association between the patients’ data and the reported complications except the association between complications and HM visual acuity ([Table 4]).
Table 4 Comparison between complicated and noncomplicated cases

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  Discussion Top


Many ocular conditions can subject the cornea to progressive thinning, impending perforation, and possible perforation. Resistant corneal ulcers and impending corneal perforation are usually with poor prognosis, including profound visual loss and various severe secondary intraocular problems [7]. Classically, the management of corneal ulcer and impending perforation include the application of bandage contact lens, gluing, conjunctival flaps, AMT, and corneal transplantation [11]. For some of these conditions, complete penetrating keratoplasty may not be the most optimal solution at the time of presentation. The urgent and emergent nature of the condition may also require immediate repair of the problem in the office [12]. The application of cyanoacrylate glue can be an effective management strategy of small corneal perforations. However, this technique is not suitable when the corneal perforation size exceeds 2.0 mm in diameter or demonstrates anterior bulging characteristics. In addition, AMT, conjunctival flaps, or bandage contact lens cannot be satisfactory permanent treatment options [13].

Following the introduction of the VisuMax femtosecond laser in 2007 [14], the intrastromal lenticule method was reintroduced in a procedure called Femtosecond Lenticule Extraction (FLEx). After the successful implementation of FLEx, a new procedure called SMILE was developed. This procedure involves passing a dissector through a small 2–3-mm incision to separate the lenticular interfaces and to allow the lenticule to be removed, thus eliminating the need to create a flap. The SMILE procedure is now gaining popularity following the results of the first prospective trials [8],[12].

Pradhan et al. [10] and Ganesh et al. [7] have separately reported their successful implantation of an allogeneic lenticule obtained by SMILE procedure from a myopic donor to correct high hyperopic patients, with no reported adverse effects during the follow‑up period. Lim et al. [15] conducted the same procedure for the treatment of presbyopia.

Regarding the use of the SMILE lenticule graft in the management of perforated corneal ulcers, Abd Elaziz et al. [1] sutured a corneal lenticule graft with a central thickness of 100 μm or more onto the corneal perforation with overlying amniotic membrane patch to regain the ocular integrity. They successfully managed a 3.1×3.4 mm perforation with this approach. Similarly, Wu et al. [16] first reported the success of using SMILE‑generated lenticules as corneal patch graft in six corneal perforation cases. In the current study, we sutured two overlapped corneal lenticule grafts with a minimum of central thickness of 65 μm each onto the impending corneal perforation. The impending corneal perforations were successfully sealed in 16 (80%) from 20 patients. Jiang et al. [9] used one or multiple lenticule grafts in their study and suggested the use of multiple pieces of lenticules in cases of deep corneal ulcers or perforations, whereas in the present study, we used two lenticules with similar diameter in all cases.

In the present study, the integrity of the globe was restored in 19 (95%) out of 20 cases, although one case of them required re-suturing due to loose stitches. Another two cases showed persistent hypotony and were managed by amniotic membrane graft augmentation. No immune rejection occurred in any patient. Only one case exhibited continuous leak with progressive infection and ended by hot penetrating keratoplasty.

The mean BSCVA showed a statistically significant improvement postoperatively at the final follow‑up.

Although Jiang et al. [9] suggested that optical coherence tomography should be used preoperatively to evaluate the depth and width of the corneal lesion, we did not think that this investigation would add much benefit as we already used two adjuvant lenticules.

Although different modalities were described to deal with impending corneal perforations in the literature, we introduce a new modality for management of such conditions by using a double stromal lenticule at the same time obtained from two different patients to solve the problem of donor shortage.


  Conclusion Top


The use of double corneal lenticule grafts was a safe and effective surgical adjuvant for impending corneal perforation closure. It is a temporary emergency measure to improve the corneal condition for further definitive interventions such as penetrating keratoplasty. It solves the problem of donor corneal graft shortage with no need for other materials such as amniotic membrane graft or fibrin glue.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Abd Elaziz MS, Zaky AG, El Saebay Sarhan AR. Stromal lenticule transplantation for management of corneal perforations; one-year results. Graefes Arch Clin Exp Ophthalmol 2017; 255:1179–1184.  Back to cited text no. 1
    
2.
Jhanji V, Young AL, Mehta JS, Sharma N, Agarwal T, Vajpayee RB. Management of corneal perforation. Surv Ophthalmol 2011; 56:522–538.  Back to cited text no. 2
    
3.
Hanada K, Shimazaki J, Shimmura S, Tsubota K. Multilayered amniotic membrane transplantation for severe ulceration of the cornea and sclera. Am J Ophthalmol 2001; 131:324–331.  Back to cited text no. 3
    
4.
Maeno A, Naor J, Lee HM, Hunter WS, Rootman DS. Three decades of corneal transplantation: indications and patient characteristics. Cornea 2000; 19:7–11.  Back to cited text no. 4
    
5.
Yagci A. Update on peripheral ulcerative keratitis. Clin Ophthalmol 2012; 6:747–754.  Back to cited text no. 5
    
6.
Hick S, Demers PE, Brunette I, La C, Mabon M, Duchesne B. Amniotic membrane transplantation and fibrin glue in the management of corneal ulcers and perforations: a review of 33 cases. Cornea 2005; 24:369–377.  Back to cited text no. 6
    
7.
Ganesh S, Brar S, Rao PA. Cryopreservation of extracted corneal lenticules after small incision lenticule extraction for potential use in human subjects. Cornea 2014; 33:1355–1362.  Back to cited text no. 7
    
8.
Hjortdal JØ, Vestergaard AH, Ivarsen A, Ragunathan S, Asp S. Predictors for the outcome of small-incision lenticule extraction for Myopia. J Refract Surg 2012; 28:865–871.  Back to cited text no. 8
    
9.
Jiang Y, Li Y, Liu XW, Xu J. A novel tectonic keratoplasty with femtosecond laser intrastromal lenticule for corneal ulcer and perforation. Chin Med J 2016; 129:1817–1821.  Back to cited text no. 9
    
10.
Pradhan KR, Reinstein DZ, Carp GI, Archer TJ, Gobbe M, Gurung R. Femtosecond laser‑assisted keyhole endokeratophakia: correction of hyperopia by implantation of an allogeneic lenticule obtained by SMILE from a myopic donor. J Refract Surg 2013; 29:777–782.  Back to cited text no. 10
    
11.
Rodríguez-Ares MT, Touriño R, López-Valladares MJ, Gude F. Multilayer amniotic membrane transplantation in the treatment of corneal perforations. Cornea 2004; 23:577–583.  Back to cited text no. 11
    
12.
Shah R, Shah S, Sengupta S. Results of small incision lenticule extraction. All-in-one femtosecond laser refractive surgery. J Cataract Refract Surg 2011; 37:127–137.  Back to cited text no. 12
    
13.
Ti SE, Scott JA, Janardhanan P, Tan DT. Therapeutic keratoplasty for advanced suppurative keratitis. Am J Ophthalmol 2007; 143:755–762.  Back to cited text no. 13
    
14.
Reinstein DZ, Archer TJ, Gobbe M, Johnson N. Accuracy and reproducibility of Artemis central flap thickness and visual outcomes of LASIK with the Carl Zeiss Meditec VisuMax femtosecond laser and MEL 80 excimer laser platforms. J Refract Surg 2010; 26:107–119.  Back to cited text no. 14
    
15.
Lim CH, Riau AK, Lwin NC, Chaurasia SS, Tan DT, Mehta JS. LASIK following small incision lenticule extraction (SMILE) lenticule re-implantation: a feasibility study of a novel method for treatment of presbyopia. PLoS ONE 2013; 8:e83046.  Back to cited text no. 15
    
16.
Wu F, Jin X, Xu Y, Yang Y. Treatment of corneal perforation with lenticules from small incision lenticule extraction surgery: a preliminary study of 6 patients. Cornea 2015; 34:658–663.  Back to cited text no. 16
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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