Enrollment complete in pivotal trial of ViaLase femtosecond laser for glaucoma
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Key takeaways:
- A pivotal trial will investigate the ViaLase femtosecond laser for primary open-angle glaucoma.
- Femtosecond laser image-guided high-precision trabeculotomy will be compared with selective laser trabeculoplasty.
ViaLase completed enrollment in the VIA-002 pivotal trial investigating femtosecond laser image-guided high-precision trabeculotomy for the treatment of primary open-angle glaucoma, according to a press release.
“Just as the femtosecond laser forever changed the landscape of refractive surgery, the prospect of the ViaLase platform doing the same as a glaucoma intervention is truly exciting,” William F. Wiley, MD, medical director at the Cleveland Eye Clinic, told Healio.
In the prospective, controlled, multicenter trial, 152 adult patients with primary open-angle glaucoma were randomly assigned to treatment with either the ViaLase laser or selective laser trabeculoplasty.
The primary effectiveness endpoint is the reduction in mean unmedicated IOP from baseline to 6 months and 12 months, and secondary effectiveness endpoints include the percentage of eyes with a 20% or greater reduction in unmedicated IOP without secondary surgical intervention and the reduction in the mean number of hypotensive medications.
“We are hopeful the results of this trial will be consistent with our first-in-human study, which published data of patients followed out to 24 months,” Richard Lewis, MD, chief medical officer of ViaLase, said in the release. “ViaLase believes our technology will give doctors the opportunity to intervene earlier in the treatment paradigm with a potentially safe and effective noninvasive procedure.”
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