|Year : 2015 | Volume
| Issue : 1 | Page : 16-21
Value of fibrin glue use with Ahmed valve implantation in refractory glaucoma
Salah M Al-Mosallamy
Department of Ophthalmology, Faculty of Medicine, Zagazig University, Zagazig, Egypt
|Date of Submission||10-Dec-2014|
|Date of Acceptance||10-Jan-2015|
|Date of Web Publication||29-May-2015|
MD Salah M Al-Mosallamy
Department of Ophthalmology, Faculty of Medicine, Zagazig University, Zagazig, 44519
Source of Support: None, Conflict of Interest: None
This study aimed to evaluate the efficacy and safety of the fibrin glue use with Ahmed glaucoma valve (AGV) implantation in refractory glaucoma.
Patients and methods
Twenty-two eyes of 22 patients diagnosed with refractory glaucoma were scheduled to receive an AGV and were grouped into two groups: group I included 12 eyes in which fibrin glue was used to secure the scleral flap and conjunctiva over the valve tube. Group II included 10 eyes in which sutures were used as the standard technique for valve implantation.
The mean age of the patients was 29.5 ± 13.4 and 27.1 ± 10.3 years in groups I and II, respectively, and there was no statistically significant difference between the two groups (P > 0.5). Congenital glaucoma was the most common preoperative diagnosis in each group. The surgical outcome of both groups showed a statistically significant reduction in the mean operation time in group I (37 ± 6 min) than in group II (43 ± 5 min) (P < 0.05). In addition, upper limbal inflammation was less in group I than in group II (17 and 40%, respectively), which was statistically significant (P < 0.05). Complete success was achieved in nine cases (75%) and qualified success was achieved in two cases (17%) in group I; in group II, complete success was achieved in eight cases (80%) and qualified success was achieved in one case (10%). There was no statistically significant difference between both groups in complete success and failure (P > 0.05). There was no statistically significant difference in the mean final intraocular pressure between the two groups (18.1 ± 2.2 and 17.4 ± 3.5 mmHg) in groups I and II, respectively (P > 0.05). The operative complications were hyphema, which occurred in one case in group I (8%) and in two cases in group II (20%). Suprachoroidal hemorrhage occurred in one case in group II. Shallow anterior chamber occurred in two cases (17%) in group I and in two cases (20%) in group II. One case in group I developed choroidal detachment. Tube exposure occurred in three cases, two cases in group I (17%), and one case (10%) in group II. Encysted valve occurred in three cases, two of which belonged to group I (17%) and one case belonged to group II (10%).
The use of fibrin glue with AGV implantation in refractory glaucoma makes its implantation easier, with a shorter operation time and less postoperative pain and inflammation, but its added cost usually limits its use. However, larger multicenter studies with longer-term follow-up are needed before the widespread use of this surgical technique.
Keywords: Ahmed valve, fibrin glue, refractory glaucoma
|How to cite this article:|
Al-Mosallamy SM. Value of fibrin glue use with Ahmed valve implantation in refractory glaucoma. Delta J Ophthalmol 2015;16:16-21
|How to cite this URL:|
Al-Mosallamy SM. Value of fibrin glue use with Ahmed valve implantation in refractory glaucoma. Delta J Ophthalmol [serial online] 2015 [cited 2017 Dec 12];16:16-21. Available from: http://www.djo.eg.net/text.asp?2015/16/1/16/157783
| Introduction|| |
Refractory glaucoma, including neovascular glaucoma, uveitis, or traumatic secondary glaucoma, aphakic or pseudophakic glaucoma, pediatric glaucomas, and previously failed trabeculectomy, are all potentially blinding diseases in which it is often difficult to control the intraocular pressure (IOP), even with maximally tolerated antiglaucoma medical treatment. The surgical options are conventional glaucoma filtering surgery with antimetabolite use, tube implantation surgery, and cyclodestructive procedures. Literature review has shown superior results of glaucoma drainage implants over other treatment options in the treatment of refractory glaucoma  .
Ahmed glaucoma valve (AGV) implantation has been used extensively and has been proved to be an effective method for treating refractory glaucoma. Current studies in the literature have reported its success rates to range from 49 to 83.6% ,, depending on the type of glaucoma and the period of follow-up.
Fibrin glue is a blood-derived product that consists of a fibrinogen component and a thrombin component. It comprises the final stages of the coagulation cascade at the time the two components are mixed. It has multiple uses in medicine, especially in neurosurgeries, plastic surgery, otolaryngeal surgery, and eye surgery  . In the field of ophthalmology, fibrin glue is currently being used in strabismus surgery, corneal surgery, amniotic membrane transplantation, and conjunctival grafting following pterygium as a suture substitute , . This is because the use of absorbable or nonabsorbable sutures to secure tissues has many disadvantages, including a complicated surgical technique, prolonged operation time, prolonged postoperative patient discomfort, and suture-related complications such as irritation and inflammation that may compromise the surgical results  .
The main component of fibrin glue is that found in human blood, and hence it is less immunogenic. Theoretically, it can transmit blood-born infection; however, there have been no reports describing postoperative infection after the use of fibrin glue in ophthalmic surgery  .
This study was designed to evaluate the use of fibrin adhesive glue as a suture substitute during AGV implantation in refractory glaucomas in terms of its efficacy and safety.
| Patients and methods|| |
This was a prospective comparative controlled study that included a total of 22 eyes of 22 patients with refractory glaucoma recruited into the study, selected from among those attending the Outpatient Clinic of Zagazig University Hospital in the period from February 2013 to October 2013, and adhered to the provisions of the Declaration of Helsinki for research involving human participants. Written informed consent was obtained from all of the participants involved in the study. Preoperative information such as age, sex, number of antiglaucoma medications, systemic diseases, etiology of glaucoma, history of previous surgery, and lens status, was noted. Preoperative assessments included best-corrected visual acuity, slit-lamp examination, IOP measurement by Goldmann applanation tonometry, gonioscopy, and dilated fundoscopy if ocular media permits. Children younger than 5 years of age were examined under general anesthesia.
Patients with no perception of light or those who had undergone previous cyclodestructive procedures and previously failed AGV implantation in the same eye or were lost to follow-up visits were excluded.
Patients were grouped into two groups: group I included 12 eyes treated by AGV implantation by securing the scleral flap and conjunctiva using fibrin glue. Group II included 10 eyes treated by AGV implantation using sutures instead and served as a control group.
All surgeries were carried out under general anesthesia by one surgeon (S.M.A.) using the standard technique for valve implantation, which was as follows: a fornix-based flap of the conjunctiva and Tenon's capsule was created in the superior temporal or superior nasal quadrant. The tube of the AGV (AGV; New World Medical Inc., Rancho Cucamonga, California, USA) was flushed with a balanced salt solution using a 27 G needle for valve priming and to ensure patency before insertion. The AGV was then positioned in the middle of the quadrant, with the anterior edge of the plate 8-10 mm from the corneoscleral limbus (measured by caliper). Then, the valve plate was sutured to the sclera with 8-0 silk sutures through the anterior positional holes of the valve plate [Figure 1]. After cauterization, a half-thickness, rectangular, 4×6 mm, limbal-based scleral flap was created. The tip of the drainage tube was then cut beveled upwards to introduce it by 2 mm into the anterior chamber. Paracentesis in the temporal peripheral cornea was performed, which helped to test the filtration during surgery and reformation of the anterior chamber postoperatively if needed. A 23 G needle punctured the anterior chamber under the scleral flap and the drainage tube was inserted.
|Figure 1: Ahmed glaucoma valve implantation S3 model during implantation of its plate.|
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In group I, fibrin glue (FIBROGLOO of Cairo Medical Centre Blood Bank) was used as follows: after drying the scleral bed using a sponge, two to three drops of prepared fibrin glue solution were placed on the scleral bed around the tube, and then a smooth forceps was used to hold the edges of the flap on both sides of the tube against its bed and kept until adherent. Then, two to three drops additional of fibrin glue were applied to the under surface of the conjunctiva and a conjunctival forceps was used to hold its edges in place until adherence was ensured [Figure 2] and [Figure 3]. The eye was examined for leak by filling the anterior chamber with a balanced salt solution.
|Figure 2: Pressure by smooth forceps on the sides of the flap To allow adherence of the glue.|
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|Figure 3: Holding the conjunctival edges in place until glue adherence was ensured.|
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In group II, the scleral flap was sutured over the tube using 8-0 silk sutures. The conjunctiva and Tenon's capsule were approximated to the limbus with 8-0 silk sutures.
Topical steroid antibiotic eye drops and ointment preparations were administered four times daily for 4 weeks. Glaucoma topical medications were prescribed when the postoperative IOP was greater than 21 mmHg.
Preparation of fibrin glue solution
FIBROGLOO is a two-component preparation consisting of lyophilized human thrombin and lyophilized human fibrinogen. Human thrombin is prepared from plasma obtained by apheresis from a single donor. The purified thrombin is aseptically dispensed into sterile vials. Fibrinogen for each batch is obtained by apheresis from a single donor. The fibrinogen is aseptically dispensed into sterile vials and lyophilized in a manner that will not impair the availability of clot formation. Each individual unit of plasma either for thrombin or fibrinogen was tested and found to be nonreactive for hepatitis B surface antigen, HIV-1 antibody, HIV-2 antibody, and HIV p-24 antigen, hepatitis C virus antibody, and antibodies to Treponema pallidum using licensed assay methods. Nuclear acid testing by PCR was negative for all viral markers.
Two vials were used: one contained a white, lyophilized, round cake of thrombin (labeled: R1) and the other contained a pale yellow, lyophilized powder of fibrinogen (labeled: R2.) [Figure 4]. When thrombin is added to fibrinogen, it is transformed into fibrin and fibrinogen coagulum occurs.
|Figure 4: FIB ROGLOO used in the study of Cairo Medical Centre Blood Bank. R1(thrombin) – R2 (fi brinogen).|
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A vial of thrombin and a vial of fibrinogen were allowed to reach ambient temperature, then the metal tabs and rubber bungs from both vials were removed, the container of sterile water for injection was opened, and 2 ml was injected in the thrombin and fibrinogen vials (1 ml in each). The vials were gently swirled for 1 min and then allowed to stand at ambient temperature for 5 min to ensure complete protein rehydration. The thrombin and fibrinogen remained viable for 60 min after reconstitution. Syringes were then placed in the duploject injector, which was specially designed so that depressing the common plunger exerted simultaneous and equal pressure on both the syringes. A mixer nose cone, topped by a blunt applicator needle, was attached to the nozzle to facilitate the mixing of the two syringe components. Alternatively, both substances were placed using separate syringes.
Postoperative IOP was recorded in addition to other ophthalmic examination data at each visit after AGV implantation surgery. The number of postoperative glaucoma medications and postoperative complications were also recorded. The postoperative visits were scheduled at 1 day, 1 week, 1, 3, 6 months, and 1 year.
Complete success was defined as IOP of 21 mmHg or less, without glaucoma medications, and without significant vision-threatening complications (endophthalmitis, retinal detachment, suprachoroidal hemorrhage, preseptal cellulitis, or persistent hypotony (IOP <5 mmHg). Qualified success was achieved when the above criteria were fulfilled, but with the use of antiglaucoma topical medications. Failure was defined as IOP more than 21 mmHg, loss of light perception, or the need for further glaucoma surgery to control IOP  .
The data were recorded and statistically analyzed using SPSS for Windows XP (version 13.0; SPSS Inc., Chicago, Illinois, USA). The χ2 or Fisher's exact test was used for categorical variables. An independent-sample t-test was used to compare data of normally distributed continuous variables between the two groups. P values of less than 0.05 were considered statistically significant.
| Results|| |
[Table 1] shows the demographic and preoperative data of the patients included in this study and their diagnosis. There was no statistically significant difference between the two groups (P > 0.5). Congenital glaucoma was the most common preoperative diagnosis in each group.
Surgical outcome of both groups showed a statistically significant reduction in the mean operation time in group I (37 ± 6 min) than in group II (43 ± 5 min) (P < 0.05). In addition, upper limbal inflammation was less in group I than in group II (17 and 40%, respectively), and this was statistically significant (P < 0.05). Complete success was achieved in nine cases (75%) and qualified success was achieved in two cases (17%) in group I, whereas in group II, complete success was achieved in eight cases (80%) and qualified success was achieved in one case (10%); there was no statistically significant difference between both groups in complete success and failure (P < 0.05). There was no statistically significant difference in the mean final IOP between the two groups (18.1 ± 2.2 and 17.4 ± 3.5 mmHg) in groups I and II, respectively (P > 0.05) [Table 2].
[Table 3] shows the complications encountered in the two groups studied. The operative complications were hyphema, which occurred in one case in group I (8%) and two cases in group II (20%); all were mild, derived from iris vessels, and resolved spontaneously in the first two postoperative days. Suprachoroidal hemorrhage occurred in one case in group II, presented 1 day postoperatively by high IOP and shallow anterior chamber; vision was perception of light. Ultrasonography showed hemorrhagic choroidal effusion with kissing choroid. Antiglaucoma treatment and atropine were administered and drainage was performed by a vitreoretinal specialist; choroid was settled, but unfortunately, the patient lost perception of light and was considered a failure. Shallow anterior chamber occurred in two cases (17%) in group I and in two cases (20%) in group II. In three of the four cases, reformation occurred spontaneously within 2-3 days postoperatively and one case in group I required reformation of the anterior chamber by air because of the development of choroidal detachment.
Late postoperative complications included tube exposure because of erosion of the overlying scleral flap. This occurred in three cases: two in group I (17%) and one case (10%) in group II; all were managed by a scleral graft and conjunctival covering over the tube. Encysted valve occurred in three cases, two of them (17%) in group I and one case (10%) in group II, which consisted of a large vascularized thick fibrous capsule around the valve plate that led to an increase in IOP and required the administration of antiglaucoma topical medications. Surgical decapsulation of this capsule was performed in one case in group I, in which the IOP exceeded 21 mmHg. IOP in this case was normalized, but because it required additional surgery to control IOP, it was considered a failure.
| Discussion|| |
Evidence suggests that the use of valves has improved the short-term, intermediate-term, and long-term surgical outcomes in the management of refractory glaucoma , . Results also confirm that AGV implant surgery provides an acceptable level of success in these cases  . The advantages of using fibrin glue in ocular surgery are well-known and include a shorter operative time and less postoperative pain and inflammation. Moreover, sutureless techniques lead to fewer incidences of infection and neovascularization  . The relatively high cost of fibrin glue usually limits its use specially in developing countries  .
This study was designed to evaluate the fibrin glue versus sutures when used with AGV in refractory glaucoma. The mean age of the patients was 29.5 ± 13.4 and 27.1 ± 10.3 in groups I and II, respectively. There was no statistically significant difference in patients' demographic and preoperative data between the two groups. Congenital glaucoma was the most common preoperative diagnosis in each group. The surgical outcome of both groups showed a statistically significant reduction in the mean operation time in group I (37 ± 6 min) than in group II (43 ± 5 min); this makes the procedure more rapid. Also, upper limbal inflammation was less in group I than in group II (17 and 40%, respectively), which was statistically significant; this was because fibrin glue use is associated with less pain and discomfort than when sutures were used as most of the sutures are associated with some degree of inflammation. In terms of the surgical success, complete success was achieved in nine cases (75%) and qualified success was achieved in two cases (17%) in group I. In group II, complete success was achieved in eight cases (80%) and qualified success was achieved in one case (10%). There was no statistically significant difference between both groups in complete success and failure. In addition, there was no statistically significant difference in the mean final IOP between the two groups (18.1 ± 2.2 and 17.4 ± 3.5 mmHg) in groups I and II, respectively. The complications were hyphema, which occurred in one case in group I (8%) and in two cases of group II (20%), suprachoroidal hemorrhage, which occurred in one case in group II, shallow anterior chamber, which occurred in two cases (17%) in group I, and in two cases (20%) in group II. One case in group I developed choroidal detachment. Tube exposure because of erosion of an overlying scleral flap occurred in three cases, two in group I (17%) and one case (10%) in group II. An encysted valve occurred in three cases, two (17%) in group I and one (10%) in group II. The last two complications were statistically significantly higher in fibrin glue group I than in sutures group II. This may be explained by the fact that group I included more cases of congenital glaucoma, which has a higher risk of valve encapsulation and tube erosion. Kahook and Noecker  were the first to use fibrin glue with glaucoma drainage devices and concluded that the major advantage of fibrin glue is evident at the time of surgery because it can be used quickly and with minimal stretching or buttonholing of the conjunctiva. As a result, the total time of surgery can be reduced by 10 min compared with cases using sutures exclusively. In addition, patient comfort that was achieved is greater when glue was used. They did not report any cases of patch graft migration or conjunctival exposure but the glue was much more expensive. In the study carried out by Quaranta et al.  , fibrin glue was used with AGV implantation; it was used to seal the pericardial patch graft and the conjunctiva over the valve tube and they found that normalization of the IOP was achieved with AGV 24 months after surgery, with no conjunctival erosion, thinning of pericardial patch graft over the tube, or tube exposure. In addition, no signs of endophthalmitis were recorded. They concluded that the sutureless fibrin glue technique using a bovine pericardial graft patch is a safe and rapid procedure for AGV implantation, but they excluded congenital glaucoma cases, which were associated with an increased risk of tube erosion from their study, and did not use a scleral flap to cover the valve tube as in the present study. To the best of our knowledge, no previous study has evaluated the use of fibrin glue to secure the scleral flap and conjunctiva during AGV implantation in refractory glaucoma.
| Conclusion|| |
The use of fibrin glue with AGV implantation in refractory glaucoma makes the implantation easier, with a shorter operation time and less postoperative pain and inflammation, but its added cost usually limits its use. However, larger multicenter studies with longer-term follow-up are needed before widespread use of this surgical technique.
| Acknowledgements|| |
Conflicts of interest
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3]