RU2821131C1 - Method for surgical management of recurrent pterygium - Google Patents

Abstract

FIELD: medicine; ophthalmosurgery.

SUBSTANCE: invention can be used for surgical treatment of recurrent pterygium. That is ensured by preparing the first and second components of the two-component autologous fibrin glue, which are filled in two different sterile syringes with volume of 1 ml. After epibulbar and subconjunctival anesthesia, pterygium head is separated from corneal surface with the help of dissector and excised with scissors to unchanged corneal stroma and sclera. Further, a portion of the limbal zone is cut out in the area of an internal quadrant of pterygium growth with the help of a dosed diamond knife with depth of 350 mcm, width of 2 mm, and a limb length of up to 4 mm, forming a bed for an autograft. Thereafter, in the upper limb quadrant of the same eye, a cornea-conjunctival graft is cut out, corresponding to the size of the excised limb zone in the inner quadrant with width of 2 mm, a limb length of up to 4 mm, using a dosed diamond knife with depth of 350 mcm. Components of the two-component autologous fibrin glue are sequentially instilled into a prepared bed for a cornea-conjunctival autograft in amount of 0.1 ml. After 2-minute exposure, the graft is moved into the prepared bed of the corresponding orientation and repeated sequential instillation of components of two-component autologous fibrin glue on laid corneal-conjunctival autograft. Operation is completed by applying a soft contact lens on the ocular surface.

EFFECT: invention provides an increase in the effectiveness of the surgical treatment of recurrent pterygium by reducing the duration of the surgical intervention, reducing the length of epithelization, minimizing the risk of postoperative inflammation due to living thrombocytes and adhesive molecules included in the two-component autologous fibrin glue, as well as reducing the postoperative discomfort of the patients.

1 cl, 11 dwg, 2 ex

Description

The invention relates to medicine, namely to ophthalmic surgery, and can be used as an effective method for surgical treatment of recurrent pterygium.

The growth of pterygium leads to a marked decrease in the quality of life of patients, starting with external discomfort, periodic inflammation and redness, worsening dry eye syndrome, and ending with the development of high degrees of astigmatism, and, as a result, a decrease in visual acuity. The only effective treatment for pterygium is its removal by various surgical methods, in particular, in combination with the intra- and postoperative use of various additional influences to reduce the frequency of recurrence of pterygium [Malozhen S.A., Trufanov S.V., Krakhmaleva D.A. Pterygium: etiology, pathogenesis, treatment. Bulletin of Ophthalmology. 2017; 133 (5): 76-83].

An important problem in ophthalmic surgery is the high risk of recurrence of pterygium, which additionally creates discomfort for the patient and requires repeated surgery. According to foreign literature, up to 97% of relapses are observed within 12 months after surgery [Ghiasian L, Samavat B, Hadi Y, Arbab M, Abolfathzadeh N. Recurrent Pterygium: A Review. J Curr Ophthalmol. 2022;33(4):367-378].

Among the risk factors for re-growth of pterygium are the fleshiness of the pterygium and abundant vascularization (stages 2 and 3 of pterygium according to the classification of Tan H. et al.), the young (up to 45 years) age of the patients, the presence of signs of inflammation in the preoperative period, etc. [Anguria P, Ntuli S, Carmichael T. Young patient's age determines pterygium recurrence after surgery. Afr Health Sci. 2014;14(1):72-76].

The main factor provoking the relapse of pterygium growth is the technique of the previous surgical intervention, namely the presence of postoperative inflammation, the application of a large number of sutures, incomplete excision of the pterygium, or excessive tissue trauma during the removal of the pterygium, which leads to more active tissue proliferation and re-growth pterygium [Aidenloo NS, Motarjemizadeh Q, Heidarpanah M. Risk factors for pterygium recurrence after limbal-conjunctival autografting: a retrospective, single-center investigation. Jpn J Ophthalmol. 2018;62(3):349-356].

Foreign and domestic literature describes various methods of surgical treatment of recurrent pterygium using materials replacing the tissue defect, combined treatment with intraoperative and postoperative use of antimetabolites, steroid drugs, postoperative beta irradiation techniques, the use of excimer lasers, as well as lamellar keratoplasty [Malozhen S.A. ., Trufanov S.V., Krahmaleva D.A. Pterygium: etiology, pathogenesis, treatment. Bulletin of Ophthalmology. 2017; 133 (5): 76-83. Borodin Yu.I., Valsky V.V., Verigo E.N. Long-term results of combined treatment of recurrent pterygium. Ophthalmology. 2007; 3:29-33. Said DG, Faraj LA, Elalfy MS, Yeung A, Miri A, Fares U, et al. Intralesional 5 fluorouracil for the management of recurrent pterygium. Eye (Lond) 2013; 27: 1123-9].

It is worth noting that none of the above methods excludes the recurrence of pterygium growth, while the method of leaving the “bare” sclera leads to the regrowth of pterygium in most cases (up to 89%), while replacing the tissue defect with various materials (plasty with an autoconjunctival flap , amniotic membrane, labial mucosa, dura mater) reduces the risk of recurrence to 33% of cases [Nuzzi R. How to minimize pterygium recurrence rates: clinical perspectives. Clin Ophthalmol. - 2018. - No. 12. P. 2347-2362. Salman A. The recurrence of pterygium after different modalities of surgical treatment. Saudi J Ophthalmol. - 2011. - No. 25(4). P.411-415].

Barrier methods for the surgical treatment of recurrent pterygium have been proposed, which are aimed at creating a mechanical obstacle to the growth of conjunctival tissue into the cornea. However, their effectiveness and expediency of use for persistently recurrent, extensive pterygium remains controversial.

Taking into account new data on the role of the limbus in the regeneration of the corneal epithelium and the recognized basic theory about the presence of limbal epithelial stem cells (LESCs) of the limbus, localized in the palisades of Vogt, as well as based on the concept of partial limbal insufficiency underlying the pathogenesis of pterygium, a search for a new a pathogenetically substantiated, effective and low-traumatic method of surgical treatment of recurrent pterygium [Zaidi FH, Bloom PA, Corbett MC. Limbal stem cell deficiency: a clinical chameleon. Eye (Lond). 2003;17(7):837-839].

There is a known method of treating recurrent large pterygium based on autoplasty [RF patent No. RU 2 551 625 C2 IPC, A61F 9/007, publ. 05.27.2015], based on reducing the size of the bulbar conjunctival defect and the possibility of selecting the required graft size at the site of pterygium excision. The technique of the operation is as follows. After separating and excision of the body and head of the pterygium, cleansing the surface of the cornea, the bulbar conjunctiva in the area of excision of the pterygium along the edge of the defect is sutured with an enveloping suture, after which the thread is tightened, forming a much smaller defect of the bulbar conjunctiva. Next, donor tissue is obtained, for which a section of the conjunctiva is used, cut out from the lower outer part of the conjunctival fornix 2 mm below the limbus. The size of the graft is calculated taking into account the size of the resulting conjunctival defect plus 1 mm around the entire perimeter of the graft being formed due to contraction of the graft in the transplant area. The graft is placed on the sclera at the site of excision of the body of the pterygium and fixed with a continuous suture to the own bulbar conjunctiva.

The proposed method makes it possible to reduce the size of the bulbar conjunctival defect and prevent the pronounced formation of scar tissue in the area of tissue sampling, which reduces the volume of surgical intervention and is more attractive for the patient in cosmetic terms.

However, despite the advantages, excision of the conjunctiva of any size remains a traumatic procedure that leads to discomfort for patients and is accompanied by a foreign body sensation and pain in the postoperative period.

Regardless of the size of the excised conjunctiva in the area of graft collection, there is a change in the structure of the conjunctiva and loss of its elasticity compared to intact areas, which causes a tendency to scarring and reduces the effectiveness of the operation [Young AL, Kam KW. Pterygium: Surgical Techniques and Choices. Asia Pac J Ophthalmol (Phila). 2019 Nov-Dec;8(6):422-423]. The process of excision and formation of the flap itself is a labor-intensive procedure and further increases the time of surgical intervention.

In addition, the presence of a defect in the area in the area of graft collection requires the use of drugs that stimulate regeneration and repair processes, in the form of gel or ointment compositions to achieve epithelization of the formed tissue defect in the postoperative period. Its presence increases the risk of developing postoperative inflammation, and this, as stated earlier, is a factor in the recurrence of pterygium growth.

In addition, graft collection in the lower-outer part of the conjunctival fornix is not always available in patients with severe cicatricial changes in the conjunctiva (cicatricial conjunctival pemphigoid, symblepharon).

The proposed method of surgical treatment is not pathogenetically substantiated and therefore the issue of its effectiveness for persistently recurrent pterygium remains debatable.

These disadvantages are partially eliminated in the method of surgical treatment of recurrent pterygium with plastic defect tissue using a donor limbal graft [RF patent No. RU 2 655 271, publ. 05/24/2018].

This method differs from the previous one in that after separating the pterygium, capturing 0.5-1.0 mm of limbal tissue, excising the separated tissues with curved corneal scissors and exposing the surface of the sclera with a surgical compass, measure the distance between the extreme points of the formed bed in the limbus area. Donor corneal graft, corresponding in shape and size

the formed bed is cut out as follows. The previously measured distance is laid on the outer part of the limbus of the donor cornea. A trephine is used to make a semicircular incision in the cornea (a trephine of the same diameter is used as on the recipient’s eye). The cornea is separated, capturing 0.5-1.0 mm of limbal tissue (to the outer border of the limbus). Curved corneal scissors are used to excise the separated area of the cornea along with a strip of limbal tissue. The donor graft is placed in a previously formed bed on the recipient's eye and first fixed with interrupted sutures (8/0 silk) at the two extreme points to the limbus. A continuous suture or separate interrupted sutures (10/0 nylon) are placed on the corneal edge of the graft. Several separate interrupted sutures (8/0 silk) are placed on the limbal edge of the graft. The conjunctiva is stretched with a sail to the limbal edge of the graft and fixed with interrupted sutures (silk 8/0).

However, the use of allograft has a number of disadvantages, namely:

1) complete dependence of the possibility of surgical intervention on the availability of donor material;

2) difficulties associated with finding donor material, its transportation and storage conditions;

3) the need for a thorough examination of donor material for blood-contact infections;

4) the problem of histocompatibility of donor and recipient tissues, which leads to the development of graft rejection and requires immunosuppressive therapy with the selection of optimal doses;

5) the risk of recurrent corneal conjunctivalization due to the high incidence of graft rejection (up to 62% of cases) [Holland E.J. Management of limbal stem cell deficiency: a historical perspective, past, present, and future. Cornea. 2015; 34: 9-15.];

6) loss of allograft functioning due to the gradual loss of donor cells over 3 years after surgery, and, as a consequence, low efficiency in the long term and re-growth of pterygium [Solomon A. Long-term outcome of keratolimbal allograft with or without penetrating keratoplasty for total limbal stem cell deficiency. Ophthalmology. 2002; 109: 1159-66].

The above disadvantages call into question the effectiveness of allolimbal transplantation in the treatment of recurrent pterygium, and this requires a search for opportunities for autolimbal transplantation.

The closest to the claimed invention is the method we chose as a prototype, and consists in collecting a corneal-conjunctival graft in the upper inner quadrant of the operated eye [Shishkin M.M., Tsyganova T.A. Limbal transplantation as a prevention of relapses of pterygium // Bulletin of OSU. 2004]. The technique of the operation is as follows. After separation and excision of the pterygium in the body area, a corneal-conjunctival graft is cut out in the upper inner quadrant of the limbus of the operated eye, the width of the corneal part is 0.5-1 mm, the thickness is about 0.2 mm, the width of the conjunctival part is 1-2 mm. The length of the limbal graft corresponds to the width of the bed of the excised pterygium in the limbus and is 2-4 mm. Next, the limbal graft is placed on the bed so that the line of the limbus of the graft coincides with the line of the limbus of the operated eye, and is sutured along the edges to the limbus with interrupted sutures (nylon 10-0), the conjunctival flap is sutured to the conjunctiva with the episclera captured.

The disadvantages of this method include:

1) the complexity of suturing, which significantly lengthens the time of surgical intervention;

2) the use of suture materials with a width of 0.06-0.08 mm, which requires care and precision to avoid breaking the thread;

3) the use of an autograft with a thickness of about 0.2 mm and its fixation with suture material, which is associated with a high risk of intraoperative damage to the graft structures;

4) insufficient thickness of the corneal-conjunctival graft (0.2 mm), which casts doubt on the effectiveness of surgical intervention, since Vogt’s palisades, which are a pool of LESCs, are localized at a depth of 300-350 μm;

5) increased discomfort of patients in the postoperative period (irritation, sensation of a foreign body, the appearance of mucous discharge) due to irritation of the outer ends of the threads;

6) the need to prescribe additional (corneoprotective) therapy due to the appearance of patient discomfort in the postoperative period;

7) sagging of the sutures in the postoperative period and the risk of autograft dislocation;

8) the need to remove sutures 10-14 days after the operation;

9) the risk of induced astigmatism when using sutures, and, as a consequence, a temporary decrease in visual acuity;

10) greater risk of postoperative infection and granuloma formation associated with suturing [Oscar Gris; Jose L Guell; Zoraida del Campo (2000). Limbal-conjunctival autograft transplantation for the treatment of recurrent pterygium. 107(2), 0-273];

11) the likelihood of developing postoperative inflammation, which, in turn, leads to increased tissue proliferation and relapse of pterygium growth.

The present invention is based on the idea of creating a fast and effective method for treating recurrent pterygium. This is achieved by using a corneal-conjunctival autograft and its fixation using the developed and patented [RF patent No. RU 2 704 256 C1 MPC, publ. 02/18/2019] two-component autofibrin glue (DAFK).

The solution to this problem is ensured by the fact that in the method of surgical treatment of recurrent pterygium, which consists of preliminary epibulbar (inocaine solution) and subconjunctival (0.2 ml of 2% lidocaine solution) anesthesia, immobilization of the pterygium head with tweezers and separating it from the corneal surface using a delaminator with subsequent excision of the pterygium with scissors to the unchanged stroma of the cornea and sclera, cutting out a section of the limbal zone in the growth zone of the pterygium (inner quadrant) using a dosed diamond knife 350 μm deep, 2 mm wide, extending along the limbus (length) up to 4 mm, separating the formed fragment of the limbus using a peeling knife, cutting out a corneal-conjunctival graft in the upper quadrant of the limbus of the same eye, corresponding to the size of the excised area of the limbus in the inner quadrant (2 mm wide, extending along the limbus (length) up to 4 mm) using a dosed diamond knife with a depth of 350 microns , instillation of the first and second components of DAPC into the prepared bed for the corneal-conjunctival autograft in a volume of 2-3 drops (0.1 ml), their exposure for 2 minutes, further movement of the autograft into the prepared bed of the appropriate orientation, repeated instillation of the components of DAPC on the laid corneal-conjunctival autograft, exposure for 2 minutes, after which the application of a soft contact lens, the operation is completed by applying a soft contact lens to the ocular surface.

The main advantages of our proposed method of surgical treatment of recurrent pterygium are:

1) reducing the time of surgical intervention due to the absence of the need for sutures, in turn, the proposed method of graft fixation using DAFC ensures strong and rapid adhesion of the bonded tissues;

2) no requirements for high surgical skills when working with the adhesive composition and eliminating the risk of thread rupture;

3) the use of an adhesive composition and the absence of piercing the autograft with a needle, which completely eliminates the risk of intraoperative damage to the graft structures;

4) increasing the efficiency of surgery by cutting out an autograft using a dosed diamond knife with a depth of 350 microns, in the structure of which the Vogt palisades and the LESK pool are preserved;

5) minimizing patient discomfort in the postoperative period due to the absence of irritation with the ends of the threads;

6) no need to use additional (corneoprotective) therapy in the postoperative period;

7) high level of tissue adhesion provided by DAPC, which completely eliminates the risk of autograft dislocation;

8) no need to remove sutures 10-14 days after the operation;

9) lower risk of astigmatism due to adhesive fixation of tissues;

10) no risk of postoperative infection and granuloma formation associated with suturing;

11) stopping the inflammatory reaction at the site of application of the adhesive composition due to the components included in DAFC, and minimizing the recurrence of pterygium.

The invention is illustrated in Fig. 1 and Fig. 2, which show photographs of the ocular surface of patient Z. (Fig. 1) and patient G. (Fig. 2) over time (before and after surgery). Figure 3 shows the separation of the pterygium head from the corneal surface using a delaminator. Figure 4 shows excision of the head of the pterygium with scissors to the intact stroma of the cornea and sclera. Figure 5 shows cutting out a section of the limbal zone in the growth zone of the pterygium (inner quadrant) using a dosed diamond knife with a depth of 350 μm, a width of 2 mm, and an extension along the limbus (length) of up to 4 mm. In fig. Figure 6 shows the formed bed for the autograft after separating the formed fragment of the limbus using a peeling knife. In fig. Figure 7 shows the cutting out of a corneal-conjunctival graft in the upper quadrant of the limbus of the same eye, corresponding to the size of the excised zone of the limbus in the inner quadrant (2 mm wide, extending along the limbus (length) up to 4 mm) using a dosed diamond knife with a depth of 350 microns. In fig. Figure 8 shows the sequential instillation of DAPC components into the prepared bed for the corneal-conjunctival autograft in a volume of 2-3 drops (0.1 ml) and exposure for 2 minutes. In fig. Figure 9 shows the state of the ocular surface after moving the graft into the prepared bed of the appropriate orientation. In fig. Figure 10 shows repeated instillation of DAPC components onto a laid corneal-conjunctival autograft. In fig. Figure 11 shows the final stage of the operation - the application of a soft contact lens to the ocular surface.

The effectiveness of our proposed method of surgical treatment of recurrent pterygium is illustrated by the following clinical cases.

Clinical case No. 1. Patient Z. applied to the ophthalmology clinic of the V.Med. CM. Kirov with complaints of a foreign body sensation, lacrimation, redness and periodic inflammation in the right eye. The patient has a history of two surgical interventions to remove pterygium using the McReynolds technique. With biomicroscopy on the cornea in meridians from 2 to 4 o.c. a growing triangular conjunctival fold is determined, passing the limbus zone by 1.5 mm. Due to persistently recurrent pterygium, the patient underwent autolimbal transplantation with graft fixation using DAFC. The postoperative period was without complications; complete epithelization was achieved on the 6th day. The patient was monitored for 1.5 years after surgery; there were no signs of regrowth of the pterygium (Fig. 1).

Clinical case No. 2. Patient G. From the anamnesis it is known that these complaints have been troubling since 2005, when the diagnosis of pterygium of the left eye was first established. The pterygium was removed, but after 4 years the patient noted a re-growth of the formation. In 2016, recurrent pterygium was removed with amniotic membrane repair. Currently, the patient is again concerned about the growth of pterygium, as well as the sensation of a foreign body, lacrimation, decreased vision in the left eye, and therefore turned to the ophthalmology clinic of the V.Med. CM. Kirov. With biomicroscopy on the cornea in the meridians from 7 to 10 am. a growing vascularized triangular conjunctival fold is determined, passing through the limbus zone and reaching the edge of the pupil. The patient underwent autolimbal transplantation with graft fixation using DAFC. The postoperative period was without complications; complete epithelization was achieved on the 3rd day. 6 months after the operation, the patient has no complaints; biomicroscopy reveals an adapted autolimbal graft in the former growth zone of the pterygium (Fig. 2, marked with an arrow), as well as cloud-like opacification of the cornea in the area of excision of the pterygium (in the meridian from 7 to 10 a.m. .ts.), there are no signs of relapse of pterygium growth.

The technical result is to increase the effectiveness of surgical treatment of recurrent pterygium by reducing the duration of surgery, reducing the time of epithelialization, minimizing the risk of postoperative inflammation due to living platelets and adhesive molecules included in DAPC, as well as reducing patient discomfort in the postoperative period.

The technical result is achieved by the fact that the first and second components of DAPC are prepared in advance in accordance with RF patent No. RU 2 704 256 C1 MPC, which are collected in 2 different sterile syringes with a volume of 1 ml. After separating the head of the pterygium from the corneal surface using a delaminator (Fig. 3), the head of the pterygium is excised with scissors to the unchanged stroma of the cornea and sclera (Fig. 4). Next, a section of the limbal zone in the growth zone of the pterygium (inner quadrant) is cut out using a dosed diamond knife with a depth of 350 microns, a width of 2 mm, and an extension along the limbus (length) of up to 4 mm (Fig. 5), forming a bed for the autograft (Fig. 6 ). After this, in the upper quadrant of the limbus of the same eye, a corneal-conjunctival graft is cut out, corresponding to the size of the excised zone of the limbus in the inner quadrant (2 mm wide, extending along the limbus (length) up to 4 mm) using a dosed diamond knife with a depth of 350 μm (Fig. 7 ). Next, sequential instillation of the components of DAPC is carried out into the prepared bed for the corneal-conjunctival autograft in a volume of 2-3 drops (0.1 ml) (Fig. 8) and after exposure for 2 minutes the graft is moved into the prepared bed of the appropriate orientation (Fig. 9). Then, sequential instillation of the DAPC components is carried out again onto the laid corneal-conjunctival autograft (Fig. 10). The operation is completed by applying a soft contact lens to the ocular surface (Fig. 11).

This method has proven itself to be an effective, simple and atraumatic method of surgical treatment of recurrent pterygium.

Claims (1)

A method of surgical treatment of recurrent pterygium, characterized by the preparation of the first and second components of two-component autofibrin glue, which are drawn into two different sterile syringes with a volume of 1 ml, after epibulbar and subconjunctival anesthesia, the head of the pterygium is separated from the corneal surface using a delaminator and excised with scissors until unchanged stroma of the cornea and sclera, then a section of the limbal zone is cut out in the area of the inner quadrant of pterygium growth using a dosed diamond knife with a depth of 350 microns, a width of 2 mm, and an extension along the limbus of up to 4 mm, forming a bed for the autograft, then in the upper quadrant of the limbus of the same the eyes cut out a corneal-conjunctival graft corresponding to the size of the excised zone of the limbus in the inner quadrant, 2 mm wide, with a length along the limbus of up to 4 mm, using a dosed diamond knife with a depth of 350 μm and carry out sequential instillation of the components of two-component autofibrin glue into the prepared bed for the corneal-conjunctival autograft in a volume of 0.1 ml, after a 2-minute exposure, the graft is moved into the prepared bed of the appropriate orientation and the components of two-component autofibrin glue are repeatedly instilled onto the laid corneal-conjunctival autograft, after which the operation is completed by applying a soft contact lens to the ocular surface.