|REVIEW ARTICLE AND META-ANALYSIS
|Year : 2021 | Volume
| Issue : 2 | Page : 73-82
Trabeculectomy with mitomycin C in uveitic glaucoma: a systematic review
Maha Said1, Joshua Blair2, Kamel M Soliman3, Ahmed M Fathalla3, Khaled Abdelazem3, Alastair K Denniston4
1 Department of Ophthalmology, University Hospitals Birmingham NHS Foundation Trust, Birmingham; Department of Ophthalmology, Faculty of Medicine, Assiut University, Assiut, Egypt, United Kingdom
2 Department of Ophthalmology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom
3 Department of Ophthalmology, Faculty of Medicine, Assiut University, Assiut, Egypt
4 Department of Ophthalmology, University Hospitals Birmingham NHS Foundation Trust; Academic Unit of Ophthalmology, Institute of Inflammation & Ageing, University of Birmingham, Birmingham, United Kingdom
|Date of Submission||04-Jan-2021|
|Date of Decision||27-Feb-2021|
|Date of Acceptance||22-Mar-2021|
|Date of Web Publication||24-Jun-2021|
PhD, MRCP, FRCOphth Alastair K Denniston
Centre for Translational Inflammation Research, Institute of Inflammation & Ageing, University of Birmingham, Birmingham B15 2TH
Source of Support: None, Conflict of Interest: None
Background Glaucoma is a nonreversible optic neuropathy that may occur primarily or secondary to ocular pathology. Uveitis is a major etiological factor for secondary glaucoma, arising either owing to the inflammation itself or resulting from therapeutic steroid use. Many patients with uveitic glaucoma ultimately require a surgical intervention to maintain optimal intraocular pressures (IOP), often after treatment failure with multiple ocular antihypertensive agents. A leading surgical option for such patients is trabeculectomy augmented by intraoperative administration of mitomycin C (MMC). However, in the context of uveitic glaucoma, the relative merit of trabeculectomy with MMC compared with alternative surgical techniques, such as valve implantation, remains a subject of debate among ophthalmic surgeons.
Study design This is a review of the literature to evaluate the efficacy and safety of trabeculectomy with MMC in uveitic glaucoma.
Materials and methods A literature review of the use of trabeculectomy with MMC administration as an initial surgical management for uveitic glaucoma in adults was performed. Articles were identified by searches of PubMed and the Cochrane Library, using a strategy that defined the target condition (uveitis OR uveitic glaucoma OR inflammatory glaucoma) AND the intervention (trabeculectomy); limitation to MMC-augmented trabeculectomy was undertaken at the abstract and full-text stage. Data extracted included age of the patients, nature of the uveitis, preoperative status in terms of IOP and number of ocular hypotensive medications used, outcomes at annual time-points including IOP, number of ocular hypotensive medications, and surgical success (defined in terms of IOP) up to 5 years postoperatively. Adverse events were also recorded.
Results The search strategy identified 498 papers, of which 32 were duplicates, 431 were excluded at abstract stage, and 28 were excluded at full-text stage; five of the 28 satisfied the inclusion criteria but were found to contain data that were entirely or largely contained within one of the other included papers. A total of seven studies were included, comprising 300 patients, with a weighted mean age of 45.8 years (range=30.0–56.9 years), and a range of uveitis syndromes including idiopathic (30%), Behcet’s disease (24.3%), Fuchs’ heterochromic uveitis (13.7%), and Vogt-Koyanagi-Harada syndrome (12.3%). Preoperative IOP and number of medications were reported in all studies. The mean (weighted) preoperative IOP was 34.2 mmHg (range=26.8–39.5 mmHg) and the mean (weighted) number of medications was 3.4 (range=2.3–4.5). Postoperative data were variably reported across the studies; the mean IOP at 1 year was reported in five studies (range=13.8–18.5 mmHg), the mean number of medications at 1 year was reported in four studies (range=0.3–2.6), and surgical success was variably defined preventing direct comparison or aggregation.
Conclusion There is limited evidence to evaluate trabeculectomy with MMC as an initial surgical intervention for uveitic glaucoma, with the available evidence being derived entirely from retrospective studies, most of which do not have a parallel comparator group. Variation in reporting limits direct comparison and aggregation of these studies. Comparison between before and after intervention provides some limited evidence of effectiveness and safety. So, there is a need for well-designed prospective randomized controlled trials with long-term follow-up to compare interventions in this vulnerable group of patients.
Keywords: mitomycin C, success rates, trabeculectomy, uveitis
|How to cite this article:|
Said M, Blair J, Soliman KM, Fathalla AM, Abdelazem K, Denniston AK. Trabeculectomy with mitomycin C in uveitic glaucoma: a systematic review. Delta J Ophthalmol 2021;22:73-82
|How to cite this URL:|
Said M, Blair J, Soliman KM, Fathalla AM, Abdelazem K, Denniston AK. Trabeculectomy with mitomycin C in uveitic glaucoma: a systematic review. Delta J Ophthalmol [serial online] 2021 [cited 2021 Sep 22];22:73-82. Available from: http://www.djo.eg.net/text.asp?2021/22/2/73/319179
| Background|| |
The WHO published a systematic review of population-based surveys in 2002, which stated that at that time ∼37 million individuals were blind globally. Of these blind individuals, 12.3% (4.4 million) had a diagnosis of glaucoma, which made it the second most common cause of worldwide blindness . This demonstrates the considerable burden that glaucomatous diseases have across the world, and how adequate prevention and treatment of glaucoma may have a significant positive effect on global blindness.
Glaucoma is an optic neuropathy characterized by progressive degeneration of retinal ganglion cells resulting in damage to the optic nerve head, often in association with an increase in the intraocular pressure (IOP) ,. Of the various causes of glaucoma, the occurrence of glaucoma in association with uveitis is an important and challenging glaucoma entity. Uveitis describes a group of disorders characterized by inflammation affecting one or more of the uveal structures (the choroid, ciliary body, and iris) and may be acute, remitting-relapsing, or chronic in its course. Causes of uveitis are extremely varied and include infectious and autoimmune pathologies. Uveitis may cause sight loss through several mechanisms, but uveitic glaucoma is one of the most common and is irreversible, unlike the other major causes of uveitic sight loss (such as cataract and macular edema). Uveitic glaucoma affects 10–20% of the patients through the course of disease, in both acute and chronic cases ,,. This risk is considerably higher in cases of pediatric uveitis, reaching up to 35% ,. However, the incidence of ocular hypertension in cases of uveitis is much higher than that of glaucoma, at ∼70%, particularly in cases of anterior uveitis. Nevertheless, the incidence of glaucoma does not vary by the anatomical site of uveitis . Uveitic syndromes that are particularly associated with higher risk of glaucoma include Fuchs heterochromic uveitis (FHU), herpetic uveitis, Posner-Schlossman syndrome, and juvenile idiopathic arthritis ,.
In uveitic patients demonstrating progression from ocular hypertension to glaucoma, it has been shown that 24% of the eyes that experienced an IOP rise by 10 mmHg or more from baseline, and 30% of the eyes with an IOP of 30 mmHg or more developed glaucoma within 2 years .
There are a variety of mechanisms through which uveitis can cause glaucoma. The main mechanisms include the induction of trabeculitis, which can impair trabecular aqueous drainage; deposition of inflammatory debris in the trabecular meshwork, which may also impair drainage; formation of synechiae, which may increase the IOP via iridocorneal or pupillary angle blockade; and the use of therapeutic corticosteroids in uveitis, which carries a greater risk when administered topically, intravitreally or periocularly. However, the risk of glaucoma in uveitis is quite variable and has a multifactorial etiology, including risk factors such as age, ethnicity, family history of glaucoma, type of steroid used, and duration of steroid use . A recent literature review has concluded that because ethnicities with darker skin pigmentation tend to be more resistant to the treatment of uveitis, they are, as a result, subject to a greater risk of developing uveitic glaucoma than comparative white populations . Additionally, some studies have highlighted the potential role of viruses such as Herpes simplex virus and Cytomegalovirus in the pathogenesis of uveitic glaucoma .
The treatment of uveitic glaucoma is challenging, but the key objective in its management is the simultaneous control of both the underlying inflammatory condition and the resulting secondary glaucoma. IOP should be maintained below target levels to avoid further damage to the retinal nerve fiber layer and as a result avoid further deterioration of visual function. This may be achieved either medically or surgically.
In cases of medical treatment failure or patient incompliance, a survey of the American Glaucoma Society members suggested that trabeculectomy with administration of mitomycin C (MMC) is considered the first line of surgical management, where there is no active inflammation . The American Glaucoma Society survey suggested that cases with active inflammation should be treated with implants with valves . On the contrary, two retrospective studies have concluded that there was no effect of active uveitis at the time of trabeculectomy with MMC on success rates. However, the studies did not evaluate the preoperative and postoperative rates of uveitis flares nor did they document the level of uveitic activity (such as anterior chamber cells or vitritis) in patients deemed to have active inflammation ,.
Trabeculectomy is an external penetrating glaucoma operation, which is the best-established surgical option for the management of glaucoma. Trabeculectomy includes the removal of a full-thickness sector of the trabecular meshwork, which lowers the resistance to aqueous humor outflow, and as a result causes a decrease in IOP. The resulting IOP decrease is the intended therapeutic target to cease or slow the process of retinal nerve fiber layer atrophy. However, trabeculectomy is linked to several postoperative complications, such as flattened anterior chamber, hyphema, excessive filtration (causing ocular hypotony and hypotony maculopathy), choroidal detachment, and cataracts. Additionally, the chronic and recurrent intraocular inflammation associated with uveitis can result in cyclitis and may gradually affect the functioning of the ciliary body, giving a higher possibility of postoperative hypotony in this patient group . MMC is an antifibrinolytic agent used to augment trabeculectomy where there is a higher risk of scarring and surgical failure, such as uveitic glaucoma.
A better understanding of the risk factors for treatment options in uveitic glaucoma is essential to guide treatment decisions, counsel patients, and bench mark good practice. One outstanding issue is the extent that uveitis poses as a risk factor for treatment failure in the context of trabeculectomy with MMC for uveitic glaucoma, and what key modifiers may be able to further enhance or reduce this risk, such as lens status, number of preoperative drops, condition of the conjunctiva, and level of inflammatory control ,. It is also important to determine the efficacy of trabeculectomy with MMC for uveitic glaucoma and to compare this to reported rates of postoperative complications, as this will guide clinical decisions regarding the choice of primary surgical intervention for this patient group.
As a result, this review aimed to examine the available literature to assess the success rate of trabeculectomy with MMC in uveitic glaucoma, the factors that may influence rates of treatment failure, and the occurrence of postoperative complications associated with this technique.
| Materials and methods|| |
A literature review of the use of trabeculectomy with MMC administration as an initial surgical management for uveitic glaucoma in adults was performed. Searches were undertaken within PubMed (including but not restricted to MEDLINE) and the Cochrane Library. Database search strategy defined the target condition (uveitis OR uveitic glaucoma OR inflammatory glaucoma) AND the broad type of intervention (trabeculectomy); narrowing to the specific type of trabeculectomy (MMC-augmented) was undertaken at the abstract and full-text stage.
All studies of adult patients with uveitic glaucoma undergoing trabeculectomy augmented with MMC as a primary operative intervention were included with outcomes reported to include one or more of IOP, numbers of ocular hypotensive medications, surgical success (defined in relation to IOP), follow-up of at least 1 year, with a loss to follow-up rate of less than 30% at that time-point, and a study size of at least 10 patients of relevant cohort. Studies that contained the intervention of interest and/or the target condition as a subgroup were eligible provided that the relevant subgroup data could be extracted from the study report.
Studies that included modifications on trabeculectomy with MMC, such as amniotic membrane graft, were excluded from this systematic review.
There were no language restrictions.
The data were extracted from January 1, 1995 to the current date at the time of search (December 28, 2020).
Data extraction and literature review outcomes
We collected data about age of the patients, nature of uveitis, preoperative status in terms of IOP, and number of ocular hypotensive medications used.
The primary outcome was surgical success at annual time points based on IOP in line with the World Glaucoma Association recommendations. The secondary outcomes included IOP, number of ocular hypotensive medications at the annual time points up to 5 years postoperatively and safety outcomes that comprised any reported adverse events at any time point.
Data were extracted into Microsoft Excel (Microsoft Corp., IBM, Chicago, Illinois, USA) with analysis being undertaken in either Microsoft Excel for Microsoft 365 MSO (16.0.130801.20240) or Revman 5 (Cochrane). Data were not estimated if only provided in graphical format (e.g., a survival curve without any tabular data to enable precision of the effect).
Owing to variation in how studies reported the primary outcome (surgical success), primary outcome data were not aggregated for these studies and were presented in a narrative format. Where studies are sufficiently homogeneous (e.g. for some secondary outcomes), these data were presented as weighted averages as descriptors, but no tests for significance have been undertaken.
| Results|| |
The search strategy identified 498 papers, of which 32 were duplicates, 431 were excluded at the abstract stage, and 28 were excluded at the full-text stage; five of the 28 satisfied the inclusion criteria but were found to contain data that were entirely or largely contained within one of the other included papers, and these were therefore excluded ([Figure 1] and [Table 1] and [Table 2]).
|Figure 1 PRISMA flowchart for assessment of primary bibliographic database search results.|
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|Table 1 Studies for systematic review of trabeculectomy augmented with mitomycin C as a primary surgical intervention in patients with uveitic glaucoma|
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|Table 2 Studies excluded at full-text stage and reason for exclusion (n=28 studies)|
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The seven included studies comprised 300 patients, with a mean age ranging from 30.0 to 56.9 years across the studies and an overall arithmetic weighted mean age of 45.8 years ([Table 3]). A range of uveitis syndromes were reported ([Table 4]). The most frequent of which were idiopathic uveitis (90/300; 30%), Behcet’s disease (73/300; 24.3%), FHU (41/300; 13.7%), and Vogt-Koyanagi-Harada syndrome More Details (VKH; 37/300; 12.3%). Of the seven included studies, three were mixed uveitis cohorts, whereas four were syndrome specific (two FHU and two Behcet’s disease).
The mean preoperative IOP was reported in all studies, with a range from 26.8 to 39.5 mmHg and a weighted arithmetic mean for the whole cohort of 34.2 mmHg ([Table 5]). The mean preoperative number of medications was reported in all studies, with a range from 2.3 to 4.5, and with an arithmetic weighted mean for the whole cohort of 3.4 medications ([Table 6]).
|Table 5 Intraocular pressure before and after augmented trabeculectomy with mitomycin C in patients with uveitic glaucoma|
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|Table 6 Number of ocular hypotensive drugs before and after augmented trabeculectomy with mitomycin C in patients with uveitic glaucoma|
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The postoperative data were variably reported across the studies. In terms of surgical success, all studies reported some measure of success, which was at least in part based on IOP, but all studies defined this differently ([Table 7]). All studies included a surgical success criterion that was broadly related to the World Glaucoma Association concept, although the threshold varied from 15 to 20 to 21 mmHg, and there was variation as to whether ‘complete success’ (threshold achieved without additional medication) or ‘qualified success’ (threshold achieved with ocular hypotensive medication) or both were reported. Six of the seven studies provided a surgical outcome that was considered to be broadly comparable: achieving an IOP of less than or equal to either 21 mmHg (five studies) or 20 mmHg (one study) with or without the use of topical medications (sometimes with additional criteria). Using this criterion, the range for ‘surgical success’ was 82.6–100% at 1 year (six studies), 76.0–82.6% at 2 years (five studies), 62.3–76.5% at 3 years (five studies), 62.3–70.6% at 4 years (three studies), and 52.9–64.7% at 5 years (four studies).
In terms of postoperative IOP, the mean IOP was provided at 1 year for five studies, at 2 and 3 years for four studies, at 4 years for three studies, and at 5 years for two studies. The range of mean IOP was 13.8–18.5 mmHg at 1 year ([Table 5]). A meta-analysis was not attempted owing in part to the inadequate information on the numbers of cases lost to follow-up, and therefore the size of cohort at each time point.
In terms of medical ocular hypotensive therapies, the number of ocular hypotensive therapies were provided at 1 year for four studies, at 2 and 3 years for three studies, and at 4 and 5 years for one study. The range of number of medications was 0.3–2.6 at 1 year ([Table 6]). Meta-analysis was not attempted owing to issues related to follow-up reporting as described earlier.
In terms of safety, adverse events were variably reported and without accompanying follow-up duration, which meant that event rates could not be calculated. Most studies only reported the presence of events; nonreporting was assumed to mean an absence of such events. Cataract was the most frequent adverse event reported (53/300 cases; 17.7%), with hyphema (19/300; 6.3%), choroidal effusion (17/300; 5.7%), hypotonous maculopathy (10/300; 3.3%), severe sight loss (4/300; 1.3%), and endophthalmitis (2/300; 0.7%) being also reported.
| Discussion|| |
This review summarizes the currently available data regarding the use of trabeculectomy with MMC as the primary surgical intervention in adult patients with uveitic glaucoma. It demonstrated that there is limited evidence to evaluate trabeculectomy with MMC as an initial surgical intervention for uveitic glaucoma, with the available evidence being derived entirely from retrospective studies. Variation in how these studies have been designed and reported limits the direct comparison and aggregation of these studies. Comparing key parameters such as IOP and number of ocular hypotensive medications before and after intervention provides some evidence of effectiveness and safety, but overall, it is salutary that such a well-established technique has such limited evidence to provide precise estimates of its actual effectiveness and safety.
So, within the limits of the available evidence, what does this review show? First, all studies showed a reduction in IOP, either reported directly (mean IOP) or as a part of the variously calculated surgical success rates or both. Across the five studies that provided data for mean IOP at 1 year, the mean IOP ranged from 13.8 and 18.5 mmHg, representing a reduction, versus the preoperative mean IOP of between 40.1 and 65.1% across those studies. Of the six studies that used a broadly comparable definition of surgical success which included a threshold of either 20 or 21 mmHg, the target IOP was achieved in between 82.6 and 100% cases at year 1 and between 62.3 and 76.5% at year 3 (five studies reporting at that time point).
Second, of the four studies that reported the postoperative number of ocular hypotensive therapies, all found the mean number of therapies to be reduced after augmented trabeculectomy. This is an important outcome given that patients are keen to cease or at least reduce their use of medications, and the significant burden and morbidity associated with their use. In this regard, the study by Elgin et al.  is a notable outlier, as it only reports a reduction from 3.3 mean number of medications preoperatively to 2.6 medications postoperatively. This is in contrast to the other three studies reporting postoperative medication data, which reported between 0.3 and 0.5 medications at year 1, postoperatively. It is to be mentioned that these studies included patients with Fuchs, but the study by Elgin et al.  did not. However, the study by Elgin et al.  had an exclusively Bechet’s cohort (similar to Yalvac et al. study ) and does report a fall in ocular hypotensive medications to 0 at 1 month, but with an increase to 1.7 by 6 months.
Third, the procedure appears to be well tolerated in terms of safety, although again the data to support this are weak. The number of serious complications was low, but there are serious limitations to how we can interpret this. The duration of follow-up in terms of person-years is not available for many of the studies, which prevents a reliable estimate of the actual event rate for these complications. Additionally, they are variably classified across the different studies, making it hard to judge the likely equivalence of two events, and their severity. For example, in some studies, hypotony was not defined; in others, it was defined in terms of an IOP level; and in others, the rate of hypotony was not provided, but hypotonous maculopathy was. Finally, most studies will report the occurrence of an adverse event but not its nonoccurrence; there is therefore the need to either assume that nonreporting equates to nonoccurrence, or deal with this as missing data. This provides additional uncertainty to the estimates of the risks of these events.
The current study highlighted the paucity of studies reporting long-term data, with few reporting beyond 2 years. Studies are generally small in size, which reduces the ability to exclude confounders or to investigate underlying reasons for variations in success rates over time. It is likely that some of the variation between studies may include demographic factors such as participant age or ethnicity, participant lens status (i.e. phakic or pseudophakic) before and after intervention, the etiology of uveitis, and operative/postoperative complications.
A fundamental challenge for those involved in making decisions regarding surgical intervention in inflammatory glaucoma is that we need to know the effectiveness and safety not just of the intervention but how that compares to any alternatives. In most cases, surgical intervention in uveitic glaucoma is undertaken when the patient has not reached target IOP despite being at or near maximal medical therapy, as reflected in the mean number of ocular hypotensive drugs being between 2.6 and 4.5 in this review. Therefore, it is likely that the management options of observation (i.e. no additional treatment) are not ethical and that the option of medical therapy has been exhausted. The most appropriate comparator would therefore be an alternative surgical option: many have been proposed and are indeed well established such as implants (commonly an Ahmed or Baerveldt implant) or minimally invasive devices ,. Prospective studies with long-term follow-up of effectiveness and safety are needed for trabeculectomy with MMC in parallel to the most viable comparators.
There are several limitations to this review, which reflect the retrospective nature of the studies included within it and a number of consequent biases, including but not limited to selection bias (which participants included in each study), incomplete data, significant rates of loss to follow-up, underreporting of poor outcomes and adverse events, and reporting bias (which studies are published and are therefore included in this review). In addition, there is the challenge of heterogeneity: uveitis consists of a large number of different syndromes, and the secondary glaucoma associated with each of these may not behave similarly in terms of both natural history and response to surgical intervention. In the current review, there was no noticeable difference between the two FHU-specific cohorts and the two Behcet’s disease cohorts, but the study would not have been sufficiently powered to formally test this. Finally, it is worth noting that there are numerous other potential factors that may influence outcome that were not sufficiently well recorded for consideration within this analysis, and for which, the currently available data would be substantially underpowered to test. These include exploring the effect of age of patients, ethnicity of patients, preinflammatory and postinflammatory control of inflammation, and cataract surgery and its timing.
| Conclusion|| |
There is limited evidence to evaluate trabeculectomy with MMC as an initial surgical intervention for uveitic glaucoma, with the available evidence being derived entirely from retrospective studies. Variation in reporting limits direct comparison and aggregation of these studies. Comparison between before and after intervention suggests that it is safe and reasonably effective, with all studies reporting a reduction in IOP at all time points reported. There is a clear need for better characterization of this pattern over time and a formal study regarding causative factors for differing success rates after trabeculectomy with MMC. The data were insufficient to interrogate whether different success rates are associated with different uveitis aetiologies, pretrabeculectomy cataract surgery, or patient age. All of these would benefit from a further study to enable better treatment decisions and patient counseling, and to establish the most appropriate place for trabeculectomy with MMC versus other surgical interventions in this group of vulnerable patients. There is a need for well-designed prospective randomized controlled trials with long-term follow-up to compare interventions to enable better treatment decisions and patient counseling in this vulnerable group of patients.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]