medwireNews: There are effective and less invasive alternatives to trabeculectomy for the management of people with advanced primary angle-closure glaucoma (PACG) with or without cataract, according to the results of two noninferiority trials reported in JAMA Ophthalmology.
In the first trial, phacogoniotomy was found to be noninferior to phacotrabeculectomy for reducing intraocular pressure (IOP) at 2 years in advanced PACG with cataract. Compared with a mean baseline level of 40 mmHg, the mean reduction in IOP was a respective 25.6 mmHg and 24.7 mmHg in each group in a per-protocol (PP) analysis. Similar reductions were also reported in an intention-to-treat (ITT) analysis, at 25.8 mmHg and 25.4 mmHg.
And in the second trial, surgical peripheral iridectomy (SPI) with goniosynechialysis and goniotomy was noninferior to trabeculectomy for lowering IOP at 1 year in advanced PACG without cataract. From baseline values of 35.9 mmHg and 38.0 mmHg, mean IOP was decreased by 20.2 mmHg and 23.1 mmHg, respectively, in an ITT analysis.
The prespecified margin for noninferiority was a difference of 4 mmHg in IOP in both trials.
“Surgery is the pivotal therapeutic strategy for PACG,” observe Xiulan Zhang (Sun Yat-sen University, Guangzhou, China) and fellow investigators for the phacogoniotomy versus phacotrabeculectomy (PVP) study.
Recently, they add, there has been a “paradigm shift” away from using trabeculectomy to more minimally invasive methods, such as phacoemulsification with intraocular lens implantation, goniosynechialysis, and goniotomy.
“Phacogoniotomy, a combination of [phacoemulsification with intraocular lens implantation], 120o goniosynechialysis, and 120o goniotomy, demonstrated robust therapeutic effects and safety profile for advanced cases of PACG with cataract,” say the researchers.
They previously reported that phacogoniotomy was noninferior to phacotrabeculectomy for reducing IOP at 1 year. Now, they report the 2-year findings of the study, including some additional endpoints such as the success of treatment and need for antiglaucomatous medications.
Complete success was defined as a postoperative IOP of 5–18 mmHg with a 20% or higher reduction from baseline without the need for antiglaucomatous medications. In the PP analysis, this was achieved in 78.0% of the 59 people who had phacogoniotomy and 84.6% of the 52 people who underwent phacotrabeculectomy (70.8% of 65 and 84.7% of 59 in the ITT analysis).
Qualified success – which was defined as for complete success but with the use of antiglaucomatous medications – was achieved in a respective 89.8% and 88.5% of patients in the PP analysis and 81.5% and 88.1% in the ITT analysis.
As for safety, the team noted no differences in postoperative complications or safety outcomes.
The applicability of the study’s findings to the wider glaucoma population are somewhat limited, however, David Friedman (Harvard University, Boston, Massachusetts, USA) and associates point out in a related editorial.
“This study took place in South China at a tertiary referral center for ophthalmology and enrolled a unique cohort of study participants with at least 180° of peripheral anterior synechiae,” they observe.
“Furthermore, the average treated baseline IOP in the study population was over 40 mm Hg, a relatively high IOP uncommon in patients with glaucoma,” they add, suggesting that “[g]eneralizing these results to those with lower IOP should be done cautiously.”
Moreover, Friedman et al note that the description of how the surgeries were performed indicate “incredible surgical skill, which may limit generalizability in less expert hands.”
The second trial of SPI with goniosynechialysis and goniotomy versus trabeculectomy, dubbed the TVG study, was also conducted solely in Southern China, again by Zhang and collaborators.
Like the PVP study, the participants in the TVG study were all Chinese, and had advanced PACG, but this time without cataracts. The respective mean age of people in the PVP and TVG studies were 66.4 and 60.3 years, and 54.0% and 59.1% were women.
Zhang et al report that qualified success rates did not significantly differ when comparing people who had SPI with goniosynechialysis and goniotomy (n=43) and those who had trabeculectomy (n=45), at 88.4% versus 93.3%. However, complete success rates were significantly lower among those who had SPI with goniosynechialysis and goniotomy (60.5 vs 82.2%).
There was no significant difference in postoperative complications between the two groups (18.6 vs 20.0%, respectively), although the need for postoperative interventions was significantly lower in those who had SPI with goniosynechialysis and goniotomy (7.0 vs 55.6%).
While further validation is required in a larger sample size, the researchers conclude that the data from the TVG study show the potential of SPI with goniosynechialysis and goniotomy as a “viable alternative to trabeculectomy,” for people with advanced PACG without cataract.
And, for those with cataract, the PVP study data “support phacogoniotomy as an alternative to phacotrabeculectomy.”
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