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CLINICAL TRIAL REPORT

Combined Phacoemulsification and STREAMLINE Surgical System Canal of Schlemm Transluminal Dilation in Eyes of Hispanic Patients with Mild to Moderate Glaucoma

ORCID Icon, &
Pages 1911-1918 | Received 01 Mar 2023, Accepted 08 Jun 2023, Published online: 04 Jul 2023
 

Abstract

Purpose

To characterize clinical outcomes of transluminal dilation of the canal of Schlemm using the STREAMLINE Surgical System combined with phacoemulsification in eyes of Hispanic patients diagnosed with mild to moderate primary open-angle glaucoma.

Methods

This was a prospective analysis of all cases performed and followed up to 12 months. All eyes underwent medication washout preoperatively. Reduction in intraocular pressure (IOP) from unmedicated baseline, as well as medications from pre-washout baseline, were analyzed at postoperative Day 1, Week 1, and Months 1, 3, 6, 9, and 12.

Results

All 37 patients were Hispanic, 83.8% were female, and mean (standard deviation) age was 66.0 (10.5) years. Mean medicated preoperative IOP was 16.9 (3.2) mmHg using a mean of 2.1 (0.9) medications, unmedicated baseline IOP (after washout) was 23.2 (2.3) mmHg, and mean IOP at every postoperative study visit was significantly lower (p<0.0002). Mean IOP from month 1 through the first postoperative year ranged from 14.7–16.2 mmHg, representing a reduction of 7.0–8.5 mmHg (30.7–36.5%). At month 12, 80% of all eyes (28/35) and 77.8% of medication-free eyes (14/18) had IOP reduction ≥20% from unmedicated baseline, and 51.4% of eyes (18/35) were medication-free. Mean medication use was significantly reduced (by 59.9–74.6%, p<0.0001) at every postoperative study visit. The only adverse event occurring in >1 eye was high IOP (n=4) which was responsive to topical medical therapy; no adverse events were attributed to the transluminal dilation procedure.

Conclusion

Transluminal dilation of the canal of Schlemm using the STREAMLINE Surgical System combined with phacoemulsification safely and effectively reduced both IOP and dependence on IOP-lowering medications in a Hispanic population diagnosed with POAG and should be considered at the time of phacoemulsification in Hispanic patients who have a need for IOP reduction, medication reduction, or both.

Disclosure

Dr Malik Y Kahook is a consultant to New World Medical and his university receives fees on his behalf for this consultancy. In addition, Dr Kahook has a patent (No. 10,729,584) issued related to STREAMLINE Surgical System technology and a patent US 2021/0322218 A1 owned by New World Medical. Funding for the conduct of this study was provided by New World Medical. The authors report no other conflicts of interest in this work.