GlaucomaNCT04949802
Glaucoma Surgery Using the ViaLase Laser System
A study testing ViaLase Laser in people with Glaucoma and Glaucoma, Open-Angle, run by Vialase, Inc. at 1 site in Hungary.
Trial summary
Prospective, single-center, multi-cohort clinical trial of ViaLase Laser for the reduction of IOP in patients with open angle glaucoma. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Glaucoma, Glaucoma, Open-Angle
- What is being tested?
- ViaLase Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2020to 16 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- 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.
- Age 45 years or older
- Available, willing, with sufficient cognitive awareness to comply with examination procedures and schedules.
- Signed written informed consent.
Who cannot join
- 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:
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- 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
- Choroiditis
- Neovascularization
- Any active choroidopathy.
- Retinal or optic nerve disorders, either degenerative or evolutive, that are not associated with the existing glaucoma condition including: proliferative diabetic retinopathy, central retinal artery occlusion, central retinal vein occlusion, wet age-related macular degeneration, dry age-related macular degeneration (e. g., presence of numerous large drusen associated with disturbance to or elevation of the retinal pigment epithelium), significant retinal pigment epithelial changes or optic atrophy, pathological myopia, red disease.
- Note: Minor diabetic retinopathy or hypertensive retinopathy are permitted.
- Elevated episcleral venous pressure associated with:
- Active thyroid orbitopathy.
- Cavernous sinus fistula.
- Sturge-Weber syndrome.
- Orbital tumors.
- Orbital congestive disease.
- Other ocular conditions as follows:
- Sequelae from trauma that would preclude safe participation in the study or reliable study assessments (e.g., chemical burns, blunt trauma, etc.)
- Chronic ocular inflammatory disease or presence of active ocular inflammation or infection (e.g., uveitis, iritis, iridocyclitis, retinitis)
- Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:
- Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow- up visits)
- Subjects with inadequate space in the anterior chamber and/or angle as determined by slit lamp examination and gonioscopy.
- Subject status as follows:
- Uncontrolled systemic disease (e.g. diabetes, hypertension) that could compromise their participation in the study.
- Use of systemic medications (either current, within 30 calendar days of screening exam, or anticipated) that may cause an increase in IOP, (e.g. systemic steroids including oral or IV formulation, topical steroids applied on the periorbital surface within ¼" of the external lid margins and oral inhaled steroids). Nasal inhaled steroids are allowed.
- Active concurrent enrollment in any investigational trial or previous participation in any investigational trial within 30 days of the screening exam.
- Women who are nursing, are pregnant or are of childbearing potential who refuse to use reliable contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Single Center Clinical Study for Femtosecond Laser Glaucoma Surgery Using the ViaLase Laser
Prospective, single-center, multi-cohort clinical trial of ViaLase Laser for the reduction of IOP in patients with open angle glaucoma.
Read the detailed description
The purpose of study is to obtain initial evidence of safety of femtosecond laser glaucoma surgery using the ViaLase Laser for the treatment of open angle glaucoma. The ViaLase Laser System is intended to create apertures through the trabecular meshwork to reduce intraocular pressure in patients with open angle glaucoma.
- Conditions
- Glaucoma, Glaucoma, Open-Angle
- Being tested
- ViaLase Laser
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViaLase LaserDevice
ViaLase Laser System to create an aperture through the trabecular meshwork for the reduction of IOP in subjects with primary open-angle glaucoma
| Study group | Role | What they receive |
|---|---|---|
| Laser | Experimental | Treated with ViaLase Laser Receives: Device: ViaLase Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean IOP
continuous, mean IOP
Measured: 12 months
Percent Change From Baseline in Intraocular Pressure
Mean Percent Change From Baseline in Intraocular Pressure
Measured: 12 months
Secondary outcomes (1)
Number of Eyes That Achieved >=20% IOP Reduction
binary, number of eyes that had an IOP reduction of at least 20% from baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Sep 2020
- Primary completion16 Dec 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vialase, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melvin Sarayba, MD, Study director, Vialase, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949802
- Sponsor's protocol ID
- VIA-001
- Status last verified
- Oct 2023
- First submitted
- 24 Jun 2021
- Last updated
- 17 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Center Clinical Study for Femtosecond Laser Glaucoma Surgery Using the ViaLase Laser
- ClinicalTrials.gov ID
- NCT04949802
- Acronym / sponsor ID
- VIA-001
- Conditions
- Glaucoma, Glaucoma, Open-Angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Vialase, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, single-center, multi-cohort clinical trial of ViaLase Laser for the reduction of IOP in patients with open angle glaucoma.
Detailed description
The purpose of study is to obtain initial evidence of safety of femtosecond laser glaucoma surgery using the ViaLase Laser for the treatment of open angle glaucoma. The ViaLase Laser System is intended to create apertures through the trabecular meshwork to reduce intraocular pressure in patients with open angle glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser | Experimental | Device: ViaLase LaserTreated with ViaLase Laser |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- Nerve abnormality characteristic of glaucoma as evaluated by clinical ophthalmoscopy defined as one or more of the following:
- Subject eye is phakic
- Mean IOP with medication at screening between 21 mmHg and 35 mmHg, inclusive.
Key exclusion criteria (37 listed)
- Previous glaucoma surgeries including stent implantation or other laser surgeries on study eye.
- Prior intraocular surgery.
- Glaucoma types as follows:
- Corneal status as follows:
- Choroid status as follows:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ViaLase LaserViaLase Laser System to create an aperture through the trabecular meshwork for the reduction of IOP in subjects with primary open-angle glaucoma | Device | Laser |
Primary outcome
Mean IOP
Time frame: 12 months
continuous, mean IOP
Percent Change From Baseline in Intraocular Pressure
Time frame: 12 months
Mean Percent Change From Baseline in Intraocular Pressure
1 secondary outcome
Number of Eyes That Achieved >=20% IOP Reduction
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melvin Sarayba, MD study director
Vialase, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ViaLase Laser in people with Glaucoma and Glaucoma, Open-Angle, run by Vialase, Inc. at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean IOP (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.