Twelve-month outcomes of Kahook Dual Blade goniotomy combined with cataract surgery in Latino patients

doi:10.21203/rs.3.rs-2074115/v1

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Twelve-month outcomes of Kahook Dual Blade goniotomy combined with cataract surgery in Latino patients

https://doi.org/10.21203/rs.3.rs-2074115/v1

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published 09 Feb, 2024

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Purpose: To evaluate 12-month surgical outcome of Kahook Dual Blade (KDB) goniotomy in combination with cataract surgery in Latino patients with open angle glaucoma (OAG) and ocular hypertension (OHT).

Methods: This retrospective study included 45 eyes of 40 patients who underwent KDB goniotomy combined with cataract extraction from January 2016 to September 2020 at two centers in South America. Primary outcome was surgical success was defined as ≥20% intraocular pressure (IOP) reduction or ≥1 medication reduction from preoperative without additional IOP-lowering procedures and an IOP ≥5 mmHg or ≤21 mmHg. Additionally, we used 2 cutoffs values for success of IOP ≤18 and ≤15 mmHg. Secondary outcomes included: IOP, medication use, best corrected visual acuity, complications and failure-associated factors.

Results: Success rates at 12 months with cutoff limits of 21, 18 and 15 mmHg were 84.3%, 75.6% and 58.7%, respectively. At 12 months, mean preoperative IOP significantly decreased from 19.23 ± 0.65 mmHg on 2.33 ± 1.04 medications to 14.33 ± 0.66 mmHg on 0.59 ± 0.94 medications, with 62% of eyes free of hypotensive medication. Eyes that developed postoperative IOP spikes had higher risk for failure using the cutoff limit of IOP ≤18 mmHg with a hazard ratio of 3.6 (95% confidence interval [CI], 1.80-7.13; p<0.001). There were no serious ocular adverse events.

Conclusions: KDB combined with cataract extraction showed safety and efficacy for decreasing IOP and the number of hypotensive medications in Latino patients after one year follow-up. Intraocular pressure spikes were associated with a higher risk for failure.

cataract surgery

glaucoma

goniotomy

intraocular pressure

Kahook dual blade (KDB)

micro-invasive glaucoma surgery

Currently, glaucoma is the leading cause of irreversible blindness worldwide. In Latinos elder than 40 years old, the prevalence of open angle glaucoma (OAG) is estimated to be 4.74%, which is comparable to that in African Americans and is significantly higher than in non-Hispanic whites [1]. Lowering of intraocular pressure (IOP) is known to reduce the risk of developing glaucoma and delay disease progression for newly diagnosed patients [2, 3]. The treatment is focused on reducing IOP pharmacologically with hypotensive drugs or surgically using laser or incisional surgery. Dysregulated aqueous humor outflow causes elevated IOP. The aqueous exits the eye either through the trabecular meshwork (TM) into Schlemm’s canal and aqueous veins or through the ciliary muscle and other downstream tissues. The region of the TM implicated in establishing IOP is the juxtacanalicular tissue [4].

Topical medications constitute an effective initial therapy for many patients, but studies have shown that it is often necessary to use multiple topical medications to achieve target IOP. Furthermore, pharmacotherapy represents a challenge because it requires an adequate dose regimen, correct instillation, persistence, and typically in an adult population, concomitant use with multiple systemic drugs [5–10]. Medication can cause local tolerability problems and chronic application of eyedrops including preservatives can result in ocular surface diseases [11].

Within the last decade, the treatment approach for OAG has undergone notable innovation with the advent of minimally invasive glaucoma surgery (MIGS) [12, 13]. Despite not offering the robust IOP reduction observed with traditional filtering procedures, this growing type of procedures may offer a good safety profile and preserves the option for additional surgery.¹² The Kahook Dual Blade knife (KDB, New World Medical, Rancho Cucamonga, CA) is a recent MIGS device that creates complete or near-complete sector removal of the TM, minimizing damage to adjacent structures. It is designed to make parallel incisions in the TM and create a strip of free tissue for removal [14, 15]. Although it is intended to be used as a standalone surgery, the device can also be used to perform a goniotomy in combination with other intraocular surgical procedures such as cataract removal. Many past studies showed the safety and effectiveness of the KDB as a surgical procedure for IOP reduction in patients with primary and secondary OAG [16–19].

Currently, there are limited publications that describe IOP and ocular hypotensive medications reduction with the use of this device in Latino patients with OAG and ocular hypertension (OHT). Therefore, the aim of this study was to determine long-term outcomes in medically treated OAG and OHT Latino patients who underwent KDB combined with cataract surgery.

A retrospective chart review was performed for all patients with OAG and OHT who underwent ab interno goniotomy with the KDB combined with cataract surgery at “Fundacion Oftalmologica de Santander – FOSCAL” (Santander, Colombia) and “Clinica de ojos Norte” (Santa Cruz de la Sierra, Bolivia) from January 2016 to September 2020 with the goal of evaluating 12 months of follow-up. Informed consent was obtained from all patients before surgery and the study was in accordance with the Declaration of Helsinki. This study was approved by the Research Ethics Committee of FOSCAL (June 4, 2021).

Patients aged ≥ 18 years with primary or secondary OAG and OHT under topical treatment with at least one hypotensive drug were included. Exclusion criteria were history of glaucoma surgery, glaucoma laser procedure within the last 3 months, corneal disease that reduced visualization of the angle structures or difficulted IOP measurements and follow-up < 6 months.

Surgery

All surgeries were performed by two surgeons (GE and MJ). Kahook Dual blade surgery was performed following cataract extraction, in the same surgical procedure. After removing the cataract and the intraocular lens was placed, a 2.2 mm temporal paracentesis was created and ocular viscoelastic device (sodium hyaluronate) was injected in the anterior chamber. Patient’s heads were tilted and the microscope was rotated about 35° to allow a clear view of the nasal angle structures with a surgical gonioprism. The KDB was inserted into the anterior chamber and the tip used to make an initial incision into the TM. With its heel resting in Schlemm’s canal, the instrument was then advanced to remove 90–120° of the TM. The TM strip was removed using microforceps and the viscoelastic was aspirated with a one-handed irrigation-aspiration system to wash the anterior chamber of blood.

Postoperative treatment included: broad-spectrum antibiotics and topical steroid eyedrops five times daily (or more often in the case of significant postoperative intraocular reflux bleeding) during the first week after surgery. Steroids were tapered over four weeks after surgery. Intraocular pressure was treated during the post-operative period according to each individualized target IOP. Clinical information, obtained through chart review, was collected for the following post-operative visits: day 1, week 1, month 1, month 3, month 6 and month 12. At every follow-up visit, the following data were collected: Snellen best corrected visual acuity (BCVA) converted into logarithm of the minimum angle resolution (logMAR), IOP measurement with Goldmann applanation tonometer, gonioscopic findings, number of hypotensive medications, optic nerve evaluation and surgery related complications.

The primary outcome measure was surgical success defined as ≥ 20% IOP reduction or ≥ 1 medication reduction (compared to preoperative IOP) without additional IOP-lowering procedures (including laser trabeculoplasty) and an IOP ≥ 5 mmHg or ≤ 21 mmHg. Secondary outcomes were mean IOP and number of hypotensive medications. Safety evaluation included postoperative BCVA (a reduction of ≥ 2 lines was considered clinically significant), surgical procedures related to the KDB surgery, intraoperative and postoperative complications. We also analyzed success based on alternative lower IOP limits of 18 and 15 mmHg. Failure was established when the success criteria were not met in at least one visit after 3 months.

Statistical analysis

A descriptive analysis was carried out with measurements of central tendency for the quantitative variables as well as relative and absolute frequency for the qualitative ones. Among the quantitative variables, normality was evaluated using Shapiro-Wilk test, graphically and statistically. Preoperative and postoperative mean BCVA and number of medications were compared using a paired t test. Intraocular pressure values were compared between preoperative and follow-up visits using a linear mixed model, then a Bonferroni post-hoc analysis was used.

Kaplan-Meier survival analyses were applied to assess success rate of the procedure at 12 months follow-up with each IOP cutoffs. Cox´s proportional hazard regression analysis was used to explore predictive factors for failure. The following potential predictors were assessed using the bivariate analysis of Log Rank test: age, gender, glaucoma diagnosis, eye laterality, baseline IOP, baseline medication, hyphema presentation and IOP spike.

Data analysis was performed using the R version 4.1.1 and RStudio version 1.4.1717 programs and an alpha of 0.05 was used.

A total of 45 eyes of 40 patients were included in the study, with a mean age of 68.7 ± 9.0 years. The most common diagnosis was primary OAG (64.5%) followed by pseudoexfoliation glaucoma (20.0%). Table 1 shows the demographics and preoperative characteristics of the patients. The mean baseline IOP and number of medications were significantly decreased at all postoperative follow-up visits (Table 2). At 12-month, IOP was reduced by 22.4%, from a mean preoperative value of 19.23 ± 0.65 mmHg to 14.33 ± 0.66 mmHg. Medications decreased from 2.33 ± 1.04 preoperatively to 0.59 ± 0.94 at 12 months after surgery. Furthermore, 62% of eyes were free of hypotensive medication at the 12-month follow-up visit. The number of eyes on ≥ 3 medications was 2 (4.4%), compared to 18 (40%) prior to surgery.

Table 1

Demographics and preoperative characteristics of the study patients (45 eyes of 40 patients).
Parameter		Number of Eyes (%)
Eye	Right	20 (44.4)
	Left	25 (55.6)
	Total	45 (100.0)
Gender	Male	23 (51.1)
	Female	17 (37.8)
	Total	40 (100.0)
Age (years)	Mean ± SD	68.7 \(\pm\) 9.0
Diagnosis	POAG	29 (64.5)
	PXG	9 (20.0)
	OHT	6 (13.3)
	PG	1 (2.2)
BCVA	Mean ± SD	0.46 ± 0.26
BCVA, best corrected visual acuity; OHT, ocular hypertension; PG, pigmentary glaucoma; POAG, primary-open angle glaucoma; PXG, pseudoexfoliative glaucoma; SD, standard deviation

Table 2

Intraocular pressure and medications change over time.
	Preop. (N = 45)	Day 1 postop. (N = 45)	Week 1 postop. (N = 45)	Month 1 postop. (N = 45)	Month 3 postop. (N = 44)	Month 6 postop. (N = 44)	Month 12 postop. (N = 44)
IOP, mmHg (mean ± SD)	19.2 ± 0.7	15.1 ± 0.7*	15.3 ± 0.7*	15.5 ± 0.7*	14.0 ± 0.7*	13.9 ± 0.7*	14.3 ± 0.7*
IOP change, %	N/A	-21.5	-20.4	-19.4	-27.2	-27.6	-22.4
Number of medications (mean ± SD)	2.3 ± 1.0	0.8 ± 0.8*	0.1 ± 0.4*	0.3 ± 0.8*	0.3 ± 0.6*	0.6 ± 0.9*	0.6 ± 0.9*
IOP, intraocular pressure; SD, standard deviation.
*p < 0.001 compared to preoperative value.

Kaplan-Meier survival analysis revealed a rate of success at 3, 6 and 12 months of 97.8%, 91.1% and 84.3%, respectively (Fig. 1A). Of those achieving success at 12 months, 37 eyes reduced ≥ 1 medications (82.2%), 28 eyes had an IOP reduction ≥ 20% (62.2%) and 27 eyes met both criteria (60%). The main reason for failure was the need for additional medications to control the IOP in 4 eyes (8.8%). None of the cases needed further glaucoma surgery to control IOP. Using the alternative IOP cutoff limits of 18 mmHg and 15 mmHg at 12 months of follow-up, patients achieved a success rate of 75.6% and 58.7%, respectively (Fig. 1B and 1C). After evaluating Cox regression analysis for each of the IOP threshold above mentioned, at 12 months, only IOP spikes were found to be a potential predictor of failure using the criterion of IOP ≤ 18 mmHg with a hazard ratio of 3.6 (95% confidence interval [CI], 1.80–7.13; p < 0.001).

Visual acuity was significantly improved from 0.46 ± 0.26 logMAR to 0.17 ± 0.17 logMAR at 12-month follow-up visit (p < 0.001). No patient showed a reduction of ≥ 2 Snellen lines of visual acuity compared with preoperative analysis. Complications were usually mild and resolved spontaneously. Intraoperatively, 1 eye (2.2%) presented an inadvertent iridodialysis and 1 case (2.2%) had a small cyclodialysis cleft, both of which were less than 2 clock hours. Postoperatively, hyphema was the most common adverse event (11.1%) but nearly all cases resolved at the first postoperative week. IOP spike occurred in 3 eyes (6.7%) during the first month.

This retrospective study presents 12 months data of goniotomy with the KDB combined with cataract surgery in a Latin population from 2 centers in south America. Our results demonstrated that this procedure provides substantial IOP and medication reduction with a favorable safety profile across different types of glaucoma. Global IOP proportional reduction at 12 months was 22.4%. The IOP reduction was accompanied by a significant decrease in antiglaucoma medications, including 62% of eyes without treatment after surgery.

The results of the present study are in line with previously reported 12-month data of non-hispanic population. A 2018 study by Sieck et al demonstrated IOP reduction from a mean of 16.7 ± 0.4 mmHg preoperatively to 13.8 ± 0.4 mmHg (p < 0.001) in 165 eyes that underwent KDB goniotomy combined with cataract extraction. Additionally, mean number of medications were significantly reduced from 1.9 ± 0.1 to 1.5 ± 0.1. Success rate at 1 year in that study was 71.8% [16]. In our cohort, 84.3% achieved success at the same timepoint analysis. This difference can be explained by the fact that most of our patients had mild to moderate glaucoma. In fact, only 1 patient of our study had severe glaucoma compared to them where 51 eyes (25.9%) were classified as severe glaucoma cases. Previous studies have demonstrated that trabecular MIGS have worse results in severe glaucoma cases compared to mild to moderate cases [20]. This might be explained by the fact that intra-scleral plexus and collector channels tend to be sclerotic in these eyes [21]. In a prospective study, Dorairaj et al reported similar outcomes after goniotomy with the KDB combined with cataract extraction. After 12-month follow-up, 57.7% of eyes achieved an IOP reduction of 20% or more and 63.5% reduced ≥ 1 antiglaucoma hypotensive medication. Our study showed a similar success rate of 62.2% with the criteria of IOP reduction of ≥ 20%. However, using the reduction of ≥ 1 medication criteria, we did find a higher success rate of 82.2%. We believe that this might be due to a higher preoperative mean number of medications in our study (2.3 ± 1.0) compared to theirs (1.6 ± 0.2) [19].

In Latino patients, short-term outcomes of KDB combined with cataract extraction has been previously described. In a recent retrospective study that evaluated the results of the KDB goniotomy combined with cataract extraction in 57 eyes of 47 patients from Brazil, over a period of 6 months, the number of eyes achieving 20% IOP reduction and/or reduction of at least one medication was 86%. Furthermore, the number of topical medications was reduced from 1.9 ± 1.0 at baseline to 0.6 ± 1.0 (p < 0.001) at the last visit [22]. Laroche et al also reported 6-months follow-up results after goniotomy with the KDB either combined with cataract extraction or as stand-alone procedure in Black and Afro-Latinx patients. In the group of combined procedure, IOP was reduced from 16.3 ± 5.4 at baseline to 13.6 mmHg postoperatively (p = 0.013) and number of medications was reduced from 2.5 ± 1.2 to 1.3 ± 1.4 (p < 0.001) [23]. The results of our study are very similar to the studies cited above. After 6 months, IOP and number of topical medications were reduced to 13.9 ± 0.6 mmHg and 0.5 ± 0.9, respectively. Moreover, success rate at 6-month follow-up visit was 91.1%, similar to the study from Ibrahim et al.

It is also worth addressing of our study that 62% of eyes were free of medication at 1 year following the procedure. Even though previous reports of KDB goniotomy combined with cataract extraction have demonstrated a significant medication reduction postoperatively, data regarding medication free patients following this surgery has not been previously published [18, 19, 24]. Lack of compliance to antiglaucoma medications is considered one of the main reasons for progression in glaucoma patients with rates that varies from 4.6–59%. Several factors might contribute for non-compliance to antiglaucoma medical treatment. Among these factors, number of used eyedrops has been identified as one of the most important [25]. Patients without a necessity of topical medication may increase their quality of life.

Our results show that patients having an IOP spike are 3.6 times more likely to fail using the IOP threshold of ≤ 18 mmHg. This result matches with findings from previous studies of gonioscopy-assisted transluminal trabeculotomy (GATT) where IOP spikes were related to failure [26–28]. In GATT, a 360-degrees trabeculotomy is created using a suture or a catheter bypassing aqueous humor directly into the collector channels and episcleral veins. Chen et al reviewed 102 eyes of 88 patients and defining failure as IOP > 21 mmHg, absence of at least 20% reduction from the preoperative IOP or performance of additional glaucoma surgery they found that one of the risk factors associated with the event was the presence of an IOP spike with a hazard ratio of 1.74 (95% confidence interval [CI], 0.95–3.17; p = 0.073) [26]. Shi et al also reported that the duration of an IOP spike in patients with juvenile open-angle glaucoma (JOAG) was associated with failure. In 70 patients they found an IOP reduction from 31.3 ± 9.5 mmHg preoperatively to 15.8 ± 2.7 at 12 months postoperatively. Of those, 52 eyes (74%) presented an IOP spike, with a median duration of 3.5 days. Patients with longer IOP spikes were more associated with failure at 12 months [27]. Qiao et al compared GATT and KDB goniotomy in patients with uncontrolled JOAG and found that patients having an IOP spike in the GATT group were 2.27 times more likely to fail than those that did not [28]. Even though the exact mechanism of IOP spikes remains unclear, in this procedure it might be related with the presence of postoperative hyphema, retained viscoelastic material or the use of topical steroids. Higher preoperative IOP has also been described as a potential risk factor for reoperation after KDB goniotomy [28]. This might be explained by a more diseased distal outflow pathway as previously described in patients with more advanced glaucoma. However, in this study we did not find any correlation between failure and high preoperative IOP, probably because most of the patients of our study were mild to moderate glaucoma cases.

To the best of our knowledge, this is the first study evaluating 12-months results of KDB goniotomy combined with cataract extraction in Latino patients with OHT and OAG. Limitations of this study included the small sample size, retrospective nature and the lack of a control group. Additionally, there was a limited follow-up period of 12 months.

In conclusion, the 12-month follow-up data presented show that KDB goniotomy combined with cataract extraction can be used effectively and safely to lower both IOP and the number of medications. In addition, one year after this procedure, patients might be likely to require no supplemental medical therapy. Lastly, patients having an IOP spike during the first postoperative month showed a higher risk for failure.

Acknowledgements

No Acknowledgements to declare for the present study.

Declaration of conflict of interest

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iDs

Gustavo Espinoza https://orcid.org/0000-0003-2519-2355

Manuel Jose Justiniano https://orcid.org/0000-0003-2258-7415

Ignacio Rodriguez-Una https://orcid.org/0000-0001-9557-6691

Fernando Godin https://orcid.org/0000-0001-8540-5784

Andres Arango https://orcid.org/0000-0003-1719-8175

Sylvia Villamizar https://orcid.org/0000-0002-7296-3522

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Twelve-month outcomes of Kahook Dual Blade goniotomy combined with cataract surgery in Latino patients

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