Outcomes of Kahook Dual Blade Goniotomy for Uveitis Associated Open Angle Glaucoma or Ocular Hypertension : Journal of Glaucoma

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New Understandings of Glaucoma: Original Studies

Outcomes of Kahook Dual Blade Goniotomy for Uveitis Associated Open Angle Glaucoma or Ocular Hypertension

Miller, Victoria J. MD; Patnaik, Jennifer L. PhD; Young, Cara E. Capitena MD; SooHoo, Jeffrey R. MD; Seibold, Leonard K. MD; Kahook, Malik Y. MD; Ertel, Monica K. MD; Palestine, Alan G. MD; Pantcheva, Mina B. MD

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doi: 10.1097/IJG.0000000000002099
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Abstract

Ocular hypertension (OHTN) and glaucoma are challenging complications of long-standing uveitis. One study of 5270 eyes in adult patients with noninfectious uveitis found the mean annual incident rate of ocular hypertension to be 14.4%.1 A multi-center study of 1593 eyes of pediatric patients with noninfectious uveitis showed that 15.8% of eyes had elevated IOP on initial presentation and an estimated incidence of any elevation of intraocular pressure (IOP) of 33.4% within 2 years.2 Elevated IOP in patients with uveitis is often multifactorial. Deposition of inflammatory cells and protein within the trabecular meshwork (TM) can lead to acute and chronic elevation of IOP.3,4 In addition, many patients with uveitis require long-term steroid therapy, which increases the risk of ocular hypertension and glaucoma.5,6 Steroids are postulated to alter the extracellular matrix of the TM and increase the resistance to aqueous outflow.7

Elevated IOP in patients with uveitis often becomes refractory to medical therapies, necessitating surgical intervention. We previously reported the first case series of patients with uveitis-associated ocular hypertension and glaucoma treated with the Kahook Dual Blade (KDB) (New World Medical, Rancho Cucamonga, CA), a goniotomy knife designed to excise trabecular meshwork and improve aqueous outflow. In this case series of 16 eyes with uveitis, we showed a 62.5% short-term success rate in achieving goal IOP. All patients in this series were on maximum-tolerated medical therapy (MTMT) with an IOP above goal before the KDB goniotomy, and they all had an IOP reduction postoperatively. Many patients were able to reduce glaucoma medications postoperatively, including oral carbonic anhydrase inhibitors.8 Herein we report our follow-up data on this original case series of patients in addition to data regarding further patients who have undergone KDB goniotomy to treat uveitis-associated OHTN and glaucoma at our institution. Through this larger case series, we aimed to identify potential risk factors for failure of KDB goniotomy among patients with uveitis-associated OHTN or glaucoma with an open angle to better select appropriate candidates for this procedure. We hypothesized that eyes with uveitis-associated glaucoma would be more likely to fail to achieve their goal IOP compared with eyes with OHTN only. We also hypothesized that eyes with preoperative anterior chamber or anterior vitreous inflammation would be more likely to fail to achieve their IOP goal.

MATERIALS AND METHODS

We performed a retrospective chart review of all patients with uveitis-associated OHTN or glaucoma who underwent KDB goniotomy alone or in combination with phacoemulsification cataract surgery at the University of Colorado Health Eye Center between August 2017 and February 2020. Approval for this study was obtained from the Colorado Multiple Institutional Review Board (COMIRB, protocol 18–1694), and this research conformed to the tenets of the Declaration of Helsinki. Patients were followed up closely after surgery; however, 2 eyes were excluded as they were lost to follow-up before 5 months postoperatively.

All patients in this case series developed OHTN refractory to MTMT and required surgical intervention. Patients in this study were also determined to have open angles without synechial angle closure clinically through gonioscopy, except for 2 patients who had peripheral anterior synechiae and also underwent goniosynechiolysis at the time of surgery. Both of these patients had a mostly open angle with scattered peripheral anterior synechiae, which led to the decision to perform simultaneous limited goniosynechiolysis. As per our previous case series, individual patient IOP goals were decided and documented preoperatively in the patients’ charts by the treating glaucoma specialist. Both target number and target percentages of IOP reduction were considered when determining the individualized goals.9–12 Patients with uveitis-associated OHTN without features of glaucoma had an IOP goal of less than or equal to 21 mm Hg with at least 20% reduction in IOP. Patients with uveitis-associated glaucoma had documented optic nerve and visual field changes consistent with glaucoma and required lower individualized IOP goals to address the severity of the glaucomatous optic neuropathy with at least a 30% reduction in IOP.13–16 The individual goal IOP was determined by the treating glaucoma specialist based on clinical data, including the baseline IOP and the severity of glaucoma.

KDB goniotomy with TM excision was performed in our department according to a standard protocol as described by Sieck et al.8,17 and in our previous case series. Postoperatively, patients were started on 1% prednisolone acetate suspension and 0.5% moxifloxacin solution. The prednisolone acetate was tapered slowly based upon the patient’s level of inflammation preoperatively and postoperatively. Surgical success was defined as reaching the goal IOP or lower for each individual patient, including ongoing medical therapy. Failure of KDB goniotomy occurred if the patient’s IOP was above goal even with medical therapy. If a patient required a second glaucoma procedure to obtain better IOP control, their IOP was included in the data up until the date of the second surgery. The range of follow-up time reflects when patients were removed from the data set if they required a secondary procedure or the time from first to last visit at our institution.

Demographic and clinical characteristics are presented both for patients and for all eyes stratified by diagnoses of uveitis-associated glaucoma and OHTN. Means and standard deviations were utilized to summarize continuous variables. Preoperative and maximum IOP values were tested for normality with the Shapiro-Wilk test, and the values were all normally distributed. Kaplan-Meier curves were used to assess time-to-event for the primary outcome of failure to maintain IOP goal. Curves are presented for the entire cohort of eyes and by diagnosis type. Cox proportional hazards models were used to examine the association of potential predictors of the outcome with sandwich estimators to account for the intra-patient correlation of some patients having 2 eyes included in the analysis. Hazards ratios (HRs) were used as relative measures of association. Variables with a P-value of <0.10 were included in the multivariate Cox proportional hazards model. SAS version 9.4 was used for data analyses (SAS Institute, Cary, NC).

RESULTS

The case series included 45 eyes of 37 patients with uveitis-associated OHTN or glaucoma that underwent KDB goniotomy with TM excision (Table 1). The ages ranged from 9–89 years old with a mean age of 45.7±21.5 years old. Twenty-three patients were female. The patients included in this study had a wide range of underlying uveitis diagnoses. Table 2 shows the number of eyes with uveitis-associated glaucoma versus uveitis-associated OHTN stratified by anatomic location of uveitis. Twenty eyes had uveitic glaucoma, while the remaining 25 eyes had OHTN. The average age of eyes with uveitic glaucoma was 60.0±20.5 years compared with 31.6±15.0 years in eyes with uveitis-associated OHTN. Most patients who had both eyes included in the study had the same diagnosis in both eyes with the exception of 1 patient who had uveitic glaucoma in 1 eye and OHTN in the other. The mean goal IOP for eyes with uveitic glaucoma was 18.4±3.6 mm Hg compared with a goal IOP of 21 for all eyes with uveitis-associated OHTN. Twenty-nine eyes (64.4%) were documented as steroid responders. Thirteen eyes (28.9%) had documented preoperative anterior chamber or anterior vitreous inflammation.

TABLE 1 - Demographic and Clinical Characteristics of the Patient Cohort
All Patients Eyes
N=37 Glaucoma n=20 OHTN n=25
Age, mean (SD) 45.7 (21.5) 60.0 (21.1) 31.6 (15.3)
Male, n (%) 14 (37.8%) 7 (38.9%) 9 (52.9%)
All Eyes N=45 Glaucoma n=20 OHTN n=25
Preoperative AC or AV cell, n (%) 13 (28.9%) 7 (35.0%) 6 (24.0%)
Maximum IOP, mean (SD) 28.3 (9.9) 26.0 (7.5) 30.2 (11.2)
Preoperative IOP, mean (SD) 34.0 (10.3) 33.1 (9.8) 34.7 (10.9)
Goal IOP, mean (SD) 18.4 (3.6) 21
Combo case w/phacoemulsification, n (%) 13 (28.9%) 6 (30.0%) 7 (28.0%)

TABLE 2 - Table of Eyes Divided by the Anatomic Location of Uveitis
Type of Uveitis No. Eyes No. Eyes With IOP at Goal (%) No. Eyes With Preoperative Inflammation
Eyes with Uveitis-Associated Glaucoma
 Scleritis 0
 Anterior 13 3 (23) 7
 Intermediate 1 1 (100) 0
 Panuveitis 5 3 (60) 0
 Retinal vasculitis 1 1 (100) 0
 Total 20 8 (40) 7
Eyes with Ocular Hypertension
 Scleritis 1 1 (100) 0
 Anterior 9 5 (55) 3
 Intermediate 12 10 (83.3) 3
 Panuveitis 2 0 (0) 0
 Retinal vasculitis 1 1 (100) 0
 Total 25 17 (68) 6

KDB goniotomy was the first incisional glaucoma surgery on 43 of 45 eyes. One eye had undergone a prior trabeculectomy, and 1 had undergone a previous Molteno glaucoma drainage device implantation. Twelve eyes had a combined phacoemulsification and KDB goniotomy and 2 eyes had a combined goniosynechiolysis and KDB goniotomy. The mean preoperative IOP of the eyes at the office visit before surgery was 34.0±10.3 mm Hg on MTMT. Twenty-five eyes required oral carbonic anhydrase inhibitors preoperatively for temporary IOP control.

Mean follow-up time was 15.2±12.1 months ranging from 0.5 to 36 months postoperatively, considering that patients were eliminated from the data analysis once they required a second surgery. At the most recent follow-up, 25 (55.6%) out of 45 eyes had an IOP that was at goal. Fifteen out of these 25 eyes with successful KDB goniotomy have remained at goal IOP for greater than 1 year postoperatively, and 7 out of these 15 eyes have remained at goal IOP for greater than 2 years postoperatively. The mean IOP of the 25 eyes with IOP at goal was 11.8 ±3.8 mm Hg.

Twenty eyes (44.4%) had IOPs that were above their set goal during the postoperative period. Fourteen eyes required an Ahmed valve glaucoma drainage device implantation during the postoperative period for uncontrolled IOP. The mean postoperative time to surgery was 4.5 months, while the median time to surgery was 2 months. Three eyes underwent subsequent micropulse transcleral cyclophotocoagulation at months 1, 3, and 7 postoperatively. Three eyes with IOP above goal were being monitored with medical therapy only at the most recent follow-up visit.

Twelve out of the 20 eyes (60.0%) with uveitis-associated glaucoma had IOPs above goal, and 8 out of 25 eyes (32.0%) with OHTN had IOPs above goal during the postoperative period. However, when univariate Cox proportional hazards for potential predictors of failure of KDB goniotomy were calculated (Table 3), a diagnosis of uveitic glaucoma did not reach a statistical significance (HR 2.1 (95%CI: 0.8–5.7), P-value=0.16. Figure 1 shows the percent survival of all eyes over time compared with the percent survival of eyes with uveitis-associated OHTN and uveitic glaucoma. Ten out of 13 eyes (77.0%) with preoperative anterior chamber or anterior vitreous inflammation had IOPs above goal during the postoperative period, and this was found to be statistically significant compared with eyes without (HR 4.6 (95%CI: 1.8–11.7, P-value=0.001). Combination cases with phacoemulsification and KDB goniotomy had a lower likelihood of failure (P-value=0.07), older age at the time of surgery had a higher likelihood of failure of KDB goniotomy (P-value=0.04), while gender was not significantly associated with the outcome. In multivariate analysis, the presence of preoperative inflammation (P-value 0.02) and older age (P-value 0.04) were found to be statistically significant predictors of surgical failure.

TABLE 3 - Cox proportional Hazards for Potential Predictors of not Achieving IOP Goal
Hazards Ratio (95% CI) Univariate Hazards Ratio (95% CI) Multivariate
HR (95%CI) P HR (95%CI) P
Uveitis-associated glaucoma vs. OHTN 2.1 (0.8–5.7) 0.16
Preoperative AC or AV cell 4.6 (1.8–11.7) 0.001 3.5 (1.3–9.8) 0.02
Combo case w/phacoemulsification 0.3 (0.1–1.1) 0.07 0.3 (0.1–1.1) 0.07
Male gender 1.8 (0.7–5.0) 0.25
Age 1.0 (1.0–1.1) 0.04 1.0 (1.0–1.0) 0.04
Note: Cox proportional hazards modeling with sandwich variance estimates to account for the correlation of some patients having 2 eyes included in the study.

F1
FIGURE 1:
Kaplan-Meier survival curve showing the percent of all eyes with a successful KDB goniotomy over time compared with the percent survival of eyes with uveitis-associated OHTN and glaucoma. The data labels shown correspond to the number of eyes with a successful KDB goniotomy at each time point on the curve for all eyes.

The mean number of preoperative medications, including oral carbonic anhydrase inhibitors was 3.7±1.2 medications. The mean number of postoperative medications through the last clinic visit was 2.5±1.9 medications for a mean reduction of 1.2±1.6 medications (P-value <0.0001*). Ten eyes have not required any medications postoperatively to maintain goal IOP.

During the follow-up time, 6 eyes (13.3%) demonstrated visual field changes consistent with progressive glaucoma. Four of these eyes were at goal IOP in the postoperative period. One of these eyes was not at goal but was being monitored on drop therapy. One of these eyes failed KDB goniotomy within 5 weeks and had a secondary procedure, so it is unclear when the visual field progression occurred. Four eyes (8.9%) were not able to complete visual fields because of patient-specific factors, while 7 eyes (15.6%) did not have enough data from visual fields to comment on progression. The remaining 28 eyes (62.2%) did not show any progression on follow-up Humphrey visual fields during the follow-up time; however, some eyes did undergo a secondary procedure during this time if they failed KDB goniotomy.

The eye that had a previous Molteno glaucoma drainage device implant had an IOP at goal at the most recent follow-up 20 months postoperatively. The eye with a previous history of trabeculectomy had an IOP that was not at goal on the most recent follow-up, but the IOP was being monitored with medical treatment only.

The most common complication was a postoperative hyphema, which occurred in 4 out of 45 eyes (8.9%). One eye with postoperative hyphema had an IOP elevated to 52 mm Hg on postoperative day 3, but the IOP improved to 9 mm Hg after restarting an oral carbonic anhydrase inhibitor. No hyphema required surgical management. Three of the 4 eyes with a hyphema had an IOP at goal at the most recent clinic visit. One eye developed cystoid macular edema 2 weeks postoperatively that was managed with local steroid therapy. This same eye then developed central retinal vein occlusion 14 months postoperatively complicated by neovascular glaucoma with an elevated IOP of 34 mm Hg.

DISCUSSION

Uveitis-associated OHTN or glaucoma remains a challenging and potentially blinding complication of uveitis. Many patients ultimately require surgical intervention, but traditional incisional glaucoma surgeries like trabeculectomy with antiproliferative agents have high rates of complications in these patients. Complete or qualified success in a study of 44 eyes of patients with uveitic glaucoma, who underwent trabeculectomy with antiproliferative agents, was 62% at 2 years. The complications’ rates were high in this study, with cataract being the most common.18 Glaucoma drainage devices have been effective in patients with uveitis, but they are prone to complications such as hypotony and corneal decompensation.19–24 The surgical success rates of Baerveldt glaucoma drainage devices have been noted to be as high as 91.7% at 2 years,19 with another study reporting a success rate of 86.9% at 1 year.20 In a retrospective comparison study of patients with uveitic glaucoma who underwent Ahmed or Baerveldt glaucoma drainage devices, surgical success was 63% in the Ahmed group and 70% in the Baerveldt group. However, rates of hypotony with failure were high in the Baerveldt group. Sixteen percent of patients in the Ahmed group required a second drainage device.24

Goniotomy has previously been used successfully in children with uveitis-associated ocular hypertension and glaucoma.25 Our previous smaller case series was the first study evaluating the use of KDB goniotomy in patients with uveitis-associated OHTN or glaucoma. In our series of 16 eyes, we reported a 62.5% success rate in achieving goal IOP at 9.6 months. While a small number of eyes were included, KDB goniotomy was a less invasive and safe option for some patients with uveitis-associated OHTN and glaucoma.8 On the basis of these initial promising results, our institution continued to perform KDB goniotomy on more patients with uveitis-associated OHTN and glaucoma, and we present our further data here in this case series with extended follow-up time.

In this case series of 45 eyes, we found a 55.6% success rate of attaining goal IOP with KDB goniotomy at a mean follow-up time of 15.2 months. This percentage is slightly lower than our previous case series but continues to demonstrate the efficacy of this procedure in a challenging patient population. While many of the eyes that failed KDB goniotomy went on to require a glaucoma drainage device implantation, the 25 eyes that attained success with this minimally invasive procedure have thus far been spared the need for device implantation. In addition, many patients were able to reduce their glaucoma medications postoperative with a mean medication reduction of 1.2 medications. Furthermore, the number of complications of KDB goniotomy in this case series was again minimal. Hyphema remained the most common complication, but affected only 4 of 45 eyes, all of which were successfully managed medically. Notably, hypotony was not a complication in any of these patients, which sets this procedure apart from traditional incisional glaucoma procedures. The failure rate of KDB goniotomy is slightly higher when compared with glaucoma drainage devices and even trabeculectomies, but the safety profile is an important consideration when deciding on surgical intervention in these complex patients.

We hypothesized that patients with underlying uveitic glaucoma might be more likely to fail goniotomy compared with those with only OHTN. On initial analysis, 60% of patients with uveitic glaucoma did not achieve the IOP goal compared with 32% of those with OHTN. The mean goal IOP for uveitic glaucoma patients was 18.4 mm Hg compared with 21 mm Hg in patients with OHTN, which could explain the difference between the 2 groups. However, the data did not reach statistical significance. Larger numbers of eyes would be needed to draw further conclusions about whether the underlying diagnosis of uveitic glaucoma is a predictor of failure for KDB goniotomy.

We also hypothesized that eyes with active inflammation would be more likely to fail with KDB goniotomy, and our results support this hypothesis. Most clinicians recommend quiescence of uveitis for several months before cataract surgery, though clinical trials supporting this paradigm are lacking.26–29 Active uveitis at the time of cataract surgery is associated with worse visual outcomes.30 While cataract surgery is not urgent or emergent in most cases, surgical intervention for elevated IOP may be required regardless of disease activity. Inflammation is well-known to affect the outcome of glaucoma surgeries, and glaucoma drainage devices have more success in eyes with uveitis than trabeculectomies for this reason.31 As with cataract surgery, the success of KDB goniotomy is likely also improved with better control of preoperative inflammation before surgery, if possible.

Interestingly, the age of the patient at the time of surgery was found to be a potential predictor of surgical failure. Older patients had a higher likelihood of failure with KDB goniotomy. The duration of uveitis and the potential time for damage to intraocular structures may explain the higher likelihood of surgical failure in older eyes. The average age of eyes with uveitic glaucoma was much higher compared with those with OHTN, which may contribute to the difference.

This study has several limitations. It is not a randomized-controlled clinical trial and is instead a small retrospective case series, albeit the largest case series of patients with uveitis-associated OHTN or glaucoma who have undergone a KDB goniotomy. As in our previous case series, the surgeons in this study likely selected for patients with a higher likelihood of surgical success, and thus this study may be limited by selection bias. Our study is also limited by short follow-up time. The mean follow-up time was 15.2 months in this case series, but this number contains the follow-up time of those eyes that were censored because of failure. It is important to note, however, that 15 eyes have remained at goal IOP for greater than 1 year postoperatively, and 7 eyes have remained at goal IOP for greater than 2 years postoperatively. Our institution will continue to follow these patients to assess longer-term outcomes for this procedure. Another limitation is that the patients in this case series had a wide range of underlying uveitis diagnoses that could affect the success of the surgery. Further studies could evaluate whether or not the predominant location of the uveitis (anterior, intermediate, posterior, or panuveitis) affected surgical success with KDB goniotomy.

While further research is still needed to draw conclusions about the efficacy of KDB goniotomy in patients with uveitis-associated OHTN and glaucoma with an open angle, this case series reinforces the safety profile of KDB goniotomy and shows that some patients may have success with this procedure. Importantly, longer-term success at IOP control allows more time for uveitis specialists to obtain quiescence with steroid-sparing therapies in patients with complicated chronic uveitis. In the presence of an open angle, uveitis-associated ocular hypertension or glaucoma was successfully managed in some cases with Kahook Dual Blade goniotomy and may be considered an option among surgical approaches to lower IOP in these patients.

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Keywords:

uveitis; ocular hypertension; glaucoma; uveitic glaucoma

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