Extended follow-up shows sustained effectiveness of canaloplasty + trabeculotomy in glaucoma
Extended safety and effectiveness data on circumferential canaloplasty and trabeculotomy (CP+TR) as a treatment for mild to moderate glaucoma was demonstrated in the 12-month ROMEO study.
The study included 72 patients with mild to moderate glaucoma that underwent CP+TR either in combination with cataract surgery or as a standalone intervention. The main outcome measures focused on mean intraocular pressure (IOP), the number of ocular hypotensive medications, changes in medication use, and the proportion of patients achieving specific IOP reduction targets or becoming medication-free. Safety outcomes were also evaluated, including adverse events and secondary surgical interventions (SSI).
The mean follow-up duration was 2.1. Among the patients in Group 1 (pre-operative IOP >18 mmHg) who underwent CP+TR with cataract surgery, the 2-year IOP reduction was significant, with a mean reduction of 28% to 15.6 mmHg. The number of medications decreased by 39%, resulting in a mean of 1.4 medications. Similarly, patients in Group 1 who received CP+TR as a standalone intervention experienced a 33% reduction in IOP to 14.7 mmHg, with a 15% decrease in medication usage.
For patients in Group 2 (pre-operative IOP ≤18 mmHg), the 2-year IOP reduction was 4.2% to 13.7 mmHg for those who had CP+TR with cataract surgery and 14.7% to 13.3 mmHg for those who had CP+TR as a standalone intervention. The mean number of medications decreased by 35% and 46%, respectively.
Overall, 75% of patients achieved either a ≥20% reduction in IOP or maintained IOP between 6 and 18 mmHg without an increase in medication use or the need for secondary surgical intervention.
The authors noted that 24 out of 72 patients became medication-free during the 2-year follow-up period, whereas 9 patients were already medication-free before surgery.
The study also reported no device-related adverse events during the extended follow-up period, although 8.3% of the eyes required additional surgical or laser interventions for IOP control after 12 months.
Reference
Williamson BK, Vold SD, Campbell A, et al. Canaloplasty and Trabeculotomy with the OMNI System in Patients with Open-Angle Glaucoma: Two-Year Results from the ROMEO Study. Clin Ophthalmol. 2023;17:1057-1066. doi: 10.2147/OPTH.S407918. PMID: 37056792; PMCID: PMC10086214.
