Glaucoma Surgery Using the ViaLase Laser System

NCT04949802 | Completed Results FDA Device

• 1 other identifier: VIA-001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, single-center, multi-cohort clinical trial of ViaLase Laser for the reduction of IOP in patients with open angle glaucoma.

Conditions

Glaucoma; Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (2)

• Mean IOP

  continuous, mean IOP

  12 months

• Percent Change From Baseline in Intraocular Pressure

  Mean Percent Change From Baseline in Intraocular Pressure

  12 months

Secondary Outcomes (1)

• Number of Eyes That Achieved >=20% IOP Reduction

  12 months

Study Arms (1)

Laser

EXPERIMENTAL

Treated with ViaLase Laser

Device: ViaLase Laser

Interventions

ViaLase Laser DEVICE

ViaLase Laser System to create an aperture through the trabecular meshwork for the reduction of IOP in subjects with primary open-angle glaucoma

Laser

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of primary open-angle glaucoma (including pigmentary and pseudoexfoliative glaucoma).
• Glaucomatous visual field defects consistent with optic nerve defects and defined as one or more of the following:
• A cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level on the pattern deviation (PD) plot; or
• Glaucoma hemi-field test "outside normal limits" Note: Visual field reliability indices (i.e., fixation losses, false positives, and false negatives) should all be less than 33%. For subjects with a screening visual acuity of 20/100 or worse, a visual field is not required, and the above criteria do not need to be met.
• Nerve abnormality characteristic of glaucoma as evaluated by clinical ophthalmoscopy defined as one or more of the following:
• Diffuse thinning, focal narrowing or notching of the optic disc rim especially at inferior or superior poles.
• Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at inferior or superior poles.
• Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.
• Subject eye is phakic
• a. If phakic, then the crystalline lens will not have visually significant cataract that is expected to require cataract surgery within next one year. Cataract will be evaluated by using the AREDS clinical lens grading system (ARLNS). Specifically, crystalline lens must have ARLNS grade of ≤ 1.5 for signs of nuclear opalescence, cortical or posterior subcapsular opacities. Lenticular opacities not characterized by the ARLNS grading system shall also be evaluated (e.g. anterior subcapsular cataracts).
• Mean IOP with medication at screening between 21 mmHg and 35 mmHg, inclusive.
• Iridocorneal angle anatomy defined as follows:
• Trabecular meshwork visible on gonioscopy defined by Shaffer grade ≥ 3.
• Normal anatomy as determined by gonioscopy.
• Light perception or better in the study eye at screening. Note: The non-study eye must not have a Snellen corrected visual acuity (CVA) of worse than 20/200 at screening.

You may not qualify if:

• Previous glaucoma surgeries including stent implantation or other laser surgeries on study eye.
• Prior intraocular surgery.
• Glaucoma types as follows:
• Traumatic, uveitic, neovascular, or angle-closure.
• Glaucoma associated with vascular disorders.
• Corneal status as follows:
• Any condition that would preclude safe participation in the study or reliable IOP assessments including active inflammation, edema, keratitis, keratoconjunctivitis, keratouveitis.
• Clinically significant dystrophy such as bullous keratopathy or Fuch's dystrophy.
• Guttata that would preclude safe participation in the study or reliable study assessments.
• Anticipated surgery of any type (including LASIK, LASEK, PRK, cataract, etc.) during the study that may alter IOP measurement.
• Corneal opacities or disorders that would inhibit visualization of the angle (such as severe arcus senilis).
• Central corneal thickness less than 440 microns or greater than 620 microns.
• Choroid status as follows:
• Choroidal detachment
• Effusion

Sponsors & Collaborators

• Vialase, Inc.: lead

Study Sites (1)

Semmeweis University Ophthalmology Clinic

Budapest, 1085, Hungary

Location

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Melvin Sarayba, MD
• Organization: ViaLase Inc.

melvin.sarayba@vialase.com

9494662856

Study Officials

• Melvin Sarayba, MD

  Vialase, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: observer-masked
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 2, 2021
• Study Start: September 1, 2020
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: October 17, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-10

Locations

HU (1)