One-Year Results of a Multicenter Study: Intraocular Pressure–Lowering Effect of Combined Phacoemulsification, Goniosynechialysis, and Goniotomy for Cases of Advanced Primary Angle-Closure Glaucoma With Cataract : The Asia-Pacific Journal of Ophthalmology

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One-Year Results of a Multicenter Study: Intraocular Pressure–Lowering Effect of Combined Phacoemulsification, Goniosynechialysis, and Goniotomy for Cases of Advanced Primary Angle-Closure Glaucoma With Cataract

Song, Yunhe MD*; Zhang, Yi MD; Li, Fei MD, PhD*; Zhang, Yingzhe MD*; Lin, Fengbin MD, PhD*; Lv, Aiguo MD; Li, Xiaoyan BM; Lu, Ping BM; Xiao, Meichun MD, PhD§; Zhang, Hengli MD, PhD; Yan, Xiaowei MS; Zhu, Xiaomin MS; Song, Wulian MD, PhD#; Zhao, Xiaohuan MD**; Gao, Xinbo MD, PhD*; Hu, Kun MD*; Liang, Xiaohong BM*; Zhang, Xi MS††; Wang, Zhenyu MD*; Shi, Jiguang BM‡‡; Zhu, Yunyun MS§§; Zhang, Yu MD*; Fan, Sujie MD; Tang, Guangxian MD, PhD; Lu, Lan MD§; Xie, Lin MD, PhD; Yuan, Huiping MD, PhD#; Zhou, Minwen MD, PhD**; Chen, Weirong MD, PhD*; Tang, Li MD, PhD; Lam, Dennis S.C. MD, FRCOphth (UK)∥∥,¶¶; Weinreb, Robert N. MD##; Zhang, Xiulan MD, PhD*;  on behalf of the PVP Study Group

Author Information
Asia-Pacific Journal of Ophthalmology 11(6):p 529-535, November/December 2022. | DOI: 10.1097/APO.0000000000000579

Abstract

Glaucoma is the leading cause of irreversible blindness worldwide.1 Primary angle-closure glaucoma (PACG) is a major subtype that causes nearly half of all cases of glaucoma-related blindness.2 Its prevalence is expected to increase by 50% in 2040; over 5 million of 32 million patients projected to have PACG could become blind. Surgery is the primary therapeutic modality for various types of glaucoma including PACG. and the conventional treatment for advanced PACG is trabeculectomy or phacotrabeculectomy.3–7

However, multiple serious complications may occur after surgery, including persistent hypotony and bleb-related complications.8,9 Moreover, these procedures have a long-learning curve and require cumbersome postoperative care.

Although it has been regarded as an alternative to filtration surgeries, phacoemulsification with intraocular lens implantation (PEI) alone or in combination with goniosynechialysis (GSL) is not the prior treatment of choice in clinical practice owing to several disadvantages.10 First, PEI alone cannot ensure a high success rate. Jacobi et al11 performed PEI for eyes with angle-closure glaucoma with a success rate of merely 72%. El Sayed et al12 reported a complete success rate of 62% in eyes with PACG that received PEI alone. Second, GSL could not confer an additional intraocular pressure (IOP)-lowering effect to that of PEI. One meta-analysis that included 8 randomized controlled trials (RCTs) suggested that GSL combined with PEI did not result in a greater reduction in IOP or need for hypotensive medication in eyes with PACG.13 Another RCT also found no difference in IOP reduction between PACG eyes that underwent PEI alone and PEI+GSL.14

In advanced PACG, PEI achieved a cumulative success rate of 66%,15 which is substantially lower than that in eyes with early or moderate PACG.14 Hence, in addition to PEI or PEI+GSL, adjunctive surgical interventions may be needed in advanced PACG.

Goniotomy (GT), a commonly performed minimally invasive glaucoma surgery (MIGS) in PACG that entails removing the diseased trabecular meshwork and the inner wall of the Schlemm canal to enhance aqueous humor outflow, has been reported to be effective and safe.16–19 It is a more straightforward procedure with a shorter learning curve. Therefore, we performed this multicenter clinical study to investigate the efficacy and safety of PEI+GSL+GT in eyes with advanced PACG with cataract.

METHODS

Study Design and Participants

This multicenter observational study was conducted at 8 domestic ophthalmic centers in China (Supplementary Digital Content 1, https://links.lww.com/APJO/A203). The study was approved by the ethical committee of Zhongshan Ophthalmic Center (ID: 2021KYPJ177) and adhered to the tenets of the Declaration of Helsinki. Written informed consent was obtained from all participants.

Patients with advanced PACG and cataract who underwent PEI+GSL+GT were enrolled between August 2020 and March 2021. The inclusion criteria were as follows: (1) age 40 years and above; (2) IOP >21 mm Hg with or without the use of ocular hypotensive medications; (3) diagnosis of PACG2,20: presence of at least 180-degree peripheral anterior synechiae (PAS) covering the nasal or inferior quadrant for surgical purposes as observed under gonioscopy, with obvious glaucomatous optic neuropathy [cup-to-disc (C/D) ratio ≥0.7, C/D ratio asymmetry >0.2, or rim width at the superotemporal and inferotemporal <0.1 vertical diameter of the optic disc], and glaucomatous visual field defects, such as nasal step, arcuate scotoma, and paracentral scotoma; (4) advanced glaucoma [according to the Hodapp-Parrish-Anderson criteria, early, moderate, and advanced stages were defined as mean deviation (MD) >−6 dB, –12 dB<MD<–6 dB, and MD≤–12 dB, respectively]21,22; (5) obvious cataract with visual acuity worse than 0.63 using Early Treatment Diabetic Retinopathy Study (ETDRS) chart, or need for lens extraction, as assessed by a clinician.

The exclusion criteria were as follows: (1) history of intraocular surgery (other than laser iridotomy or laser iridoplasty) or ocular trauma; and (2) other types of glaucoma including open-angle glaucoma, secondary angle-closure glaucoma, steroidal glaucoma, and angle regression glaucoma.

Ocular Examinations

The medical history and ocular hypotensive medications in use were documented. All participants underwent comprehensive ophthalmic examinations preoperatively and postoperatively, including anterior and posterior segment examination using slit-lamp biomicroscopy (BQ-900; Haag-Streit) with a slit-lamp lens (Ocular 90 D Slit-Lamp Lenses; Ocular), and IOP measurement using Goldmann applanation tonometry (AT900; Haag-Streit). The technicians at the subcenters were trained before enrollment and all examinations were conducted according to a standard operating procedure to achieve a high level of consistency. Visual acuity and best-corrected visual acuity examinations were performed using ETDRS charts (Precision Vision) at a distance of 4 meters. The axial length and anterior chamber depth measurements were performed using IOL Master 700 (Carl Zeiss Meditec). The visual field test was performed using the 24-2 Swedish Interactive Thresholding Algorithm standard by a Humphrey field analyzer (Mark III; Carl Zeiss Meditec).

Surgical Procedures and Postoperative Management

All surgeries were performed by experienced glaucoma surgeons under general or superficial anesthesia. Routine PEI was performed with a main incision of 2.2 to 3.2 mm in width at the superior or temporal quadrant. GT was performed in the nasal or inferior quadrant because the collector channels are mainly concentrated in the nasal quadrant, followed by the inferior quadrant of the eyeball.23–25

For the temporal approach, the patient’s head was rotated 35 to 40 degrees away from the surgeon, and the surgical microscope was tilted 30 to 40 degrees downward toward the surgeon to enable maximal visualization of the nasal angle.26 A surgical goniolens was placed on the cornea to observe the angle and the trabecular meshwork. GSL was performed by gently pressing the PAS with a chopper over a range of 120 degrees. Afterward, GT was performed by inserting the tip of a microblade (Tanito Microhook; Inami & Co, Ltd) into the Schlemm canal; the inner wall of the Schlemm canal and trabecular meshwork was incised over 120 degrees (Supplementary Digital Content Videos 1, https://links.lww.com/APJO/A204 and 2, https://links.lww.com/APJO/A205). The corneal incisions were sealed after aspiration of the viscoelastic and blood.

Postoperative care included a course of topical glucocorticoid eye drops (1% prednisone acetate) and ointment (tobramycin and dexamethasone) for 7 days, followed by topical nonsteroidal anti-inflammatory drug (NSAID) eye drops for another 21 days. If transient IOP elevation occurred after surgery and the eye was considered a steroid responder,27,28 topical steroid eye drops were immediately replaced with NSAIDs.

Complete success was defined as postoperative IOP within the range of 6 to 18 mm Hg, and a reduction of 20% from baseline without loss of light perception, additional ocular hypotensive medication, and reoperation. The definition of qualified success was similar to that of complete success, except for the need for ocular hypotensive medications.14,29 Postoperative ocular hypotensive medications were adjusted according to the IOP at each visit.

Statistical Analysis

The continuous variables were presented as the mean±SD and the categorical variables were presented as frequencies (%). Comparisons between baseline and postsurgical IOP were performed using paired t tests. Kaplan-Meier analysis was performed to estimate the complete success rate during the study. A logistic regression model was generated to evaluate the potential factors associated with surgical success. The factors associated with surgical success in the univariate model (P<0.10) were considered potential confounders in the multivariable models, and the results are presented as odds ratios (ORs). Statistical significance was defined as a 2-sided P value <0.05. Statistical analyses were performed using the Stata Statistical Software 16 (StataCorp.).

RESULTS

Eighty-three eyes of 83 participants were included in the study (Table 1). The participants’ mean age was 64.1±9.3 years, and 61.5% were women. The mean best-corrected visual acuity was 0.88±1.25 logMAR (logarithm of the minimum angle of resolution) and the average MD of the visual field was –25.04±5.59 dB. The patients had a mean disease course of 2.9 (range=1.5–10.0) years, and 20 of the 83 eyes (24.1%) had a history of an acute attack.

TABLE 1 - Baseline Demographics and Glaucoma Status
Characteristics Study eyes
Participants (no. eyes) 83 (83)
Women 51 (61.5)
Age (y) 64.1±9.3
Baseline IOP (mm Hg) 27.4±7.3
Range of IOP (mm Hg) 21.0–55.0
BCVA (logMAR) 0.88±1.25
ACD (mm) 2.14±0.44
AL (mm) 22.6±0.9
Endothelial cell density (cells/mm2) 2582.5±444.3
MD of visual field (dB) −25.04±5.59
PSD of visual field (dB) 6.35±3.78
History of acute episodes 20 (24.1)
Mean duration of disease (range) (y) 2.9 (1.5–10.0)
ACD indicates anterior chamber depth; AL, axial length; BCVA, best-corrected visual acuity; IOP, intraocular pressure; logMAR, logarithm of the minimum angle of resolution; MD, mean deviation; PSD, pattern standard deviation.
Data are presented as n (%) or mean±SD.

As shown in Table 2, the mean baseline IOP was 27.4±7.3 mm Hg, which plummeted abruptly to 12.8±5.0 mm Hg 1 day after surgery. The surgical effect lasted for 12 months at the level of 14.2±2.6 mm Hg and achieved an absolute reduction of 13.0±7.8 mm Hg, with an average percentage reduction of 44.8±15.8%. A statistically significant decrease in IOP could be observed at each time point (Table 2, Fig. 1, all with P<0.001). A Kaplan-Meier curve summarized the complete and qualified success rates at different visits (Fig. 2). Complete success was achieved in 74 of 83 eyes (89.1%) and qualified success was observed in 79 of 83 (95.2%) eyes at the 1-year follow-up. Table 3 shows the number of eyes treated with ocular hypotensive medications at baseline and at each visit. The mean number of medications taken by the patients was 2.0 and reduced to a mean of 0.3 at the final visit. At baseline, the proportion of medication-free eyes was 18.1%, which significantly improved to 79.5% with successful control of IOP <18 mm Hg (P<0.0001; McNemar test). Sixty-five of 83 (78.3%) eyes benefited from a decrease in ocular hypotensive medications.

TABLE 2 - Mean IOP and Changes From Baseline, and Surgical Outcomes at Each Time Point
Baseline (n=83) Day 1 (n=83) Day 7 (n=83) Month 1 (n=83) Month 3 (n=83) Month 6 (n=83) Month 12 (n=83)
IOP (mm Hg) 27.4 (7.3) 12.8 (5.0) 13.1 (5.1) 13.3 (3.3) 13.2 (2.1) 13.8 (2.4) 14.2 (2.6)
Absolute change from baseline (mm Hg) 14.6 (8.3) 14.3 (8.7) 14.2 (7.2) 14.2 (6.9) 13.6 (7.4) 13.0 (7.8)
Percentage change from baseline 51.3 (20.7) 49.7 (21.7) 49.7 (14.2) 49.7 (11.4) 47.3 (13.4) 44.8 (15.8)
P <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
Surgical success [n (%)]
 Complete success 74 (89.1) 73 (87.9) 80 (96.4) 77 (92.7) 73 (87.9) 74 (89.1)
 Qualified success 83 (100) 79 (95.1) 80 (96.4) 83 (100) 81 (97.5) 79 (95.2)
IOP indicates intraocular pressure.
Data are expressed as the mean (SD).
Bold values indicate statistically significant differences between the IOP at baseline and at each time point.

F1
FIGURE 1:
Mean intraocular pressure at each time point for eyes undergoing combined phacoemulsification, goniosynechialysis, and goniotomy.
F2
FIGURE 2:
Kaplan-Meier analysis showing the estimated success rates of intraocular pressure control during the follow-up.
TABLE 3 - Number of Eyes Under Ocular Hypotensive Medication at Each Visit
No. hypotensive medications 0 1 2 3 4 5
Baseline 15 (18.07) 11 (13.25) 17 (20.48) 25 (30.12) 13 (15.66) 2 (2.41)
Month 12 70 (84.34) 2 (2.41) 8 (9.64) 3 (3.61) 0 (0) 0 (0)
Data are presented as n (%).

Hyphema (n=9) and IOP spike (n=9) were the most common postoperative complications, followed by corneal edema (n=8). There were no vision-threatening complications or need for reoperation during the follow-up. IOP spikes in all eyes were controlled with the withdrawal of steroids and replacement with NSAIDs, indicating that the IOP spike was related to steroid use.

The association of age, sex, history of acute attack, baseline anterior chamber depth, axial length, MD, pattern standard deviation, and baseline IOP with surgical success was evaluated using univariate and multivariate models (Table 4). Older age was significantly associated with a higher probability of complete success (OR=1.13; 95% CI: 1.02–1.25; P=0.020) but not with qualified success (P=0.239).

TABLE 4 - Multivariate Logistic Regression Analysis for the Factors Associated With Surgical Success
Complete success Qualified success
Characteristics OR (95% CI) P OR (95% CI) P
Age, per year increase 1.13 (1.02–1.25) 0.020 1.12 (0.89–1.44) 0.239
Male sex 0.67 (0.15–2.91) 0.590 13.78 (0.92–6299.17) 0.401
History of acute attack 2.06 (0.32–13.35) 0.450 1.79 (0.07–47.97) 0.727
ACD, per mm increase 3.01 (0.42–21.64) 0.273 * *
AL, per mm increase 1.27 (0.46–3.46) 0.495 1.71 (0.12–25.13) 0.695
MD, per dB exacerbation 1.02 (0.96–1.10) 0.487 1.26 (0.93–1.69) 0.131
Baseline IOP, per mm Hg increase 1.09 (0.97–1.23) 0.159 1.06 (0.85–1.31) 0.417
ACD indicates anterior chamber depth; AL, axial length; IOP, intraocular pressure; MD, mean deviation; OR, odds ratio.
*The OR of ACD was omitted because of significant collinearity with qualified success.

DISCUSSION

This study investigated the 1-year IOP-lowering effect of the combination of PEI+GSL+GT for the treatment of advanced PACG. The IOP declined from 27.4±7.3 mm Hg at baseline to 14.2±2.6 mm Hg with a percentage reduction of 44.8±15.8%. The mean number of ocular hypotensive medications used decreased from 2.0 to 0.3 at the final visit. The complete surgical success rate was 89.1%, and the qualified success rate was 95.2%. A few surgical complications were observed. This study found that compared with PEI alone or PEI+GSL in PACG with cataract,11,12,15 additional GT with PEI+GSL contributed to a higher success rate. This finding was consistent with a small-scale RCT, which found that PEI+GSL+GT yielded better IOP control than PEI+GSL.17

Various kinds of microblades or microhooks were used for GT in PACG eyes. A retrospective study by Dorairaj et al19 investigated the efficacy of PEI+GSL+GT assisted with a Kahook dual blade in 42 eyes with early (7.1%), moderate (31.0%), and advanced (61.9%) PACG. At the 12-month follow-up, the average IOP decreased from 25.5±0.7 to 13.3±0.7 mm Hg, with a reduction of 12.3 mm Hg (47.2%); the decline in IOP 24 months after surgery was 12.0 mm Hg (47.1%). Tanito et al30 assessed the surgical results of 71 patients with PACG and mixed glaucoma, who underwent GT assisted with Tanito microhook (with or without PEI), out of 560 eyes. The average IOP of all enrolled patients decreased from 20.2 to 13.9 mm Hg, with a percentage reduction of 31%; the number of average ocular hypotensive medications decreased from 2.8 to 2.5 (11%). Furthermore, IOP ≤15 mm Hg and a ≥20% of IOP reduction were achieved only in 64% of the patients. Gupta et al26 evaluated the surgical outcomes of PEI+GSL+GT assisted with a microvitreoretinal blade in treating PACG. Among 38 patients (46 eyes), 69.6% were advanced glaucoma. For all patients, the baseline IOP was 21.4±6.6 mm Hg and decreased to 14.2±3.7 mm Hg, with a mean reduction of 7.3±1.0 mm Hg during 11.7±5.5 months of follow-up. The cumulative qualified success rate (IOP <18 mm Hg with or without medications) at month 22 was 87.8±0.07%. Wang et al31 evaluated the efficacy and safety of PEI+GSL combined with trabectome in 22 eyes with PACG. A 12-month cumulative surgical success (IOP <21 mm Hg with or without topical antiglaucoma medications) rate was 88.9%. The IOP decreased from 22.07±6.62 mm Hg at baseline to 15.06±3.39 mm Hg (P=0.001), and the number of topical hypotensive medication fell from 2.68±1.17 to 0.78±0.73 (P<0.01). Compared with previous studies, our study had a larger sample size of 83 PACG eyes that were followed up for 1 year. All the eyes were in the advanced stage with a mean MD of –25.04±5.59 dB, a mean C/D ratio of 0.95, and a prolonged history of PACG from 1.5 to 10 years. Our study achieved a complete success rate of 92.7%, 87.9%, and 89.1% and a qualified success rate of 100%, 97.5%, and 95.2% at months 3, 6, and 12, respectively. The mean IOP reduction at months 3, 6, and 12 were 49.7±11.4%, 47.3±13.4%, and 44.8±15.8%, respectively (Table 2). The findings were similar to that of the studies mentioned above.32

PEI+GSL+GT resolves the anatomical factors contributing to IOP elevation in PACG. PEI removes the pupillary block, deepens the anterior chamber, enhances the outflow of aqueous humor, and reduces the risk of PAS. GSL mechanically separates the PAS and reopens the angle structures. Previous histological studies showed that the pathological changes in the trabecular meshwork in PACG eyes were similar to that in primary open-angle glaucoma,33 and tissue damage causes high resistance to aqueous humor outflow. GT removes the diseased trabecular meshwork, reduces the resistance of aqueous outflow to the Schlemm canal, and ultimately reduces IOP.33,34

PEI+GSL+GT surgery causes fewer complications than those with other procedures, as reported by earlier studies.16,18,30 Previous studies reported that the prevalence of hyphema was 12.5% to 31% after PEI+GSL+GT.26,35 In our study, hyphema occurred in 10.84% of eyes. Furthermore, only 9 cases (10.84%) of postoperative IOP spike were observed in our study, which was considerably lower than that of other ab interno trabeculotomy approaches (>30%).36 This may be attributed to the timely withdrawal of steroid eye drops within 7 days. The IOP spike was probably caused by postoperative topical instillation of glucocorticoid eye drops. After GSL+GT, the PAS and part of the inner wall of the Schlemm canal were opened. The contact area of the glucocorticoid molecules with the trabecular meshwork also increased, and the resistance to aqueous humor outflow became stronger.37,38 Therefore, early withdrawal of topical steroids may be an important step in preventing IOP spikes. The mechanisms underlying IOP spikes in MIGS require further investigation.

The current study suggested that only older age was associated with a higher complete success rate, as revealed by the multivariate logistic regression model (OR=1.13; 95% CI: 1.02–1.25). The probable mechanism was that the aging might lead to a malfunction of the trabecular meshwork, therefore raise the resistance of aqueous outflow.39–41 Thus, a GT may be more effective in older patients by removing the diseased trabecular meshwork. A few previous studies investigated the factors associated with surgical success. Cubuk and Unsal42 demonstrated that the presence of intraoperative blood in Schlemm canal is a prognostic factor for successful gonioscopy-assisted transluminal trabeculotomy (GATT; OR=1.47; 95% CI: 1.25–1.68). Shi et al43 reported that older age and longer duration of postoperative IOP spike were risk factors for the failure of GATT in the treatment of juvenile open-angle glaucoma. Our study found that the IOP spike and hyphema did not influence surgical success in PACG. These differences may be related to the 120-degree incision used in our study compared with the 360-degree approach in GATT, in which hyphema and IOP spikes are more common.

This study has some limitations. First, this single-arm study lacked comparative data to support the application of this surgical method over traditional glaucoma filtering surgery or PEI alone. Notably, our group is currently conducting an RCT comparing the surgical outcomes of phacotrabeculectomy and phacogoniotomy (ie, PEI+GSL+GT) (Clinicaltrials.gov; identifier: NCT04878458).44 Second, the 1-year follow-up duration was relatively short. A longer follow-up duration is needed to determine the long-term effect of PEI+GSL+GT on PACG with cataract.

In summary, this study demonstrated the remarkable IOP-lowering effect of PEI+GSL+GT for advanced PACG with cataract, with a few mild self-healing complications during the 1-year follow-up, providing basic evidence for the safe application and easy access of MIGS for PACG with cataract.

ACKNOWLEDGMENTS

The authors thank all staff at the Clinical Research Center of Zhongshan Ophthalmic Center for their efforts in this study.

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Keywords:

angle-closure glaucoma; cataract; goniosynechialysis; goniotomy; minimally invasive glaucoma surgery; phacoemulsification

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