Combined cataract surgery with iStent inject reduces medication burden in glaucoma
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Key takeaways:
- Combined cataract surgery with iStent inject significantly reduced medication burden in patients with glaucoma.
- They experienced a substantial improvement in patient-reported outcomes.
The addition of iStent inject, an ab interno trabecular micro-bypass device, to cataract surgery reduced ocular hypotensive medication usage among patients with glaucoma, according to a study published in Ophthalmology Glaucoma.
The aim of the study was “to assess the efficacy for lowering IOP, reducing glaucoma medication and improving quality of life outcomes at 2 years following the implantation of the second-generation trabecular micro-bypass stent system in patients with mild to moderate open angle glaucoma and cataract in a tertiary Australian population,” Jennifer C. Fan Gaskin, MD, FRANZCO, a research fellow at the Centre for Eye Research Australia, and colleagues wrote.
In a prospective, randomized, assessor-masked controlled trial, researchers evaluated the efficacy and safety of combined cataract surgery with iStent inject (Glaukos) compared with cataract surgery alone in 101 eyes from 87 patients aged 53 to 85 years (men, n = 68; mean age, 73.3 years) with mild to moderate glaucoma.
Researchers randomly assigned patients’ eyes 1:1 to combined cataract surgery with iStent inject (treatment group, n = 56) or cataract surgery alone (control group, n = 48), and followed up with them for 2 years.
The number of ocular hypotensive medications and IOP at 24 months after surgery served as the study’s co-primary effectiveness endpoints.
Secondary effectiveness endpoints included ocular comfort, measured by the Ocular Surface Disease Index questionnaire, and vision-related quality of life, measured by the Glaucoma Activity Limitation questionnaire (GAL-9), at 24 months.
The researchers also assessed safety measures, including postoperative visual acuity, any unplanned return to the operating theater, adverse events and complications.
At baseline, patients in the treatment and control groups showed similar mean medicated IOP (17.7 mm Hg ± 4 vs. 17.1 mm Hg ± 3.1) and number of ocular hypotensive medications (1.69 ± 1.05 vs. 1.8 ± 1.22).
At 24 months, the number of ocular hypotensive medications reduced to 0.7 ± 0.9 in the treatment group compared with 1.5 ± 1.9 in the control group, with an adjusted difference of 0.6 (P = .008) fewer medications per eye in the treatment group.
Overall, 57% of eyes in the treatment group were on no glaucoma medications compared with 36% in the control group.
“There was a significant difference demonstrated at 24 months of the primary effectiveness endpoint measure, with fewer glaucoma medications required on average in the iStent group compared to the control group, and a greater proportion of eyes that were medication-free at 24 months in the iStent group compared to the control group,” the researchers wrote.
Additionally, there was no clinically significant difference in IOP between the two groups, nor was there a substantial difference in OSDI or the GAL-9, at the 24-month visit.
“This is consistent with the lack of differences in patient-reported outcomes between treatment groups reported in previous glaucoma clinical trials; also keeping in mind that this study was not specifically designed or powered to compare meaningful differences in patient-reported outcomes between treatment groups,” the researchers wrote. “However, it validates the impact cataract surgery can have on all aspects of vision-related QOL.”
Perspective
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Most glaucoma patients experience a huge medication burden after surgical intervention, underscoring the need for better treatment options. This prospective, randomized, controlled study evaluated the efficacy and safety of combined cataract surgery with iStent inject compared with cataract surgery alone in patients with mild to moderate glaucoma.
Patients who underwent combined cataract surgery with iStent inject demonstrated a significant reduction in the number of IOP-reduction medications needed compared with the control group 24 months after surgery, indicating a better surgical outcome and potential therapeutic benefit.
However, the iStent inject may not have a significant long-term or sustained effect on IOP control, as the study did not find a statistically significant difference in IOP between the two groups after the initial 24-month postoperative period.
A major limitation in this study was the inadequate sample size, making it underpowered. There was potential bias, as the surgeons were not masked to the treatment groups, and also from protocol deviations as a result of the COVID-19 pandemic.
Clinicians may recommend the iStent inject to patients, as it facilitates aqueous humor outflow to reduce IOP, promising a better quality of life and treatment efficacy.
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