Open-Angle GlaucomaNCT02928289
Safety and Effectiveness of the Sight Sciences VISCO™360 Versus SLT in Primary Open Angle Glaucoma
A study testing VISCO360 ab interno canaloplasty surgery and Selective Laser Trabeculoplasty (SLT) in people with Open-Angle Glaucoma, run by Sight Sciences, Inc. at 6 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in reducing intraocular pressure (IOP) in adult, pseudophakic subjects with open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Open-Angle Glaucoma
- What is being tested?
- VISCO360 ab interno canaloplasty surgery and Selective Laser Trabeculoplasty (SLT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 6 sitesUnited States
- Study dates
- 23 Jan 2017to 17 Jan 2019
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with primary open-angle glaucoma (POAG) in the study eye.
- Pseudophakic with Posterior Chamber IOL (PCIOL)
- Able and willing to attend follow up visits for two years post-operative
- Able and willing to sign informed consent
Who cannot join
- Phakia or aphakia
- Previous glaucoma procedure with or without an implantable glaucoma device (including incisional surgery, ALT, iridectomy/iridotomy, etc.) [Subjects with one prior SLT application (>3 months prior to screening) or prior ECP (performed > 12 months prior to screening) can be enrolled].
- Use of more than 3 ocular hypotensive medications (combination medications count as 2 medications)
- Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma
- Abnormal angle anatomy as determined by gonioscopy (e.g. peripheral anterior synechiae, rubeosis or other angle abnormalities)
- Participation in any clinical trial ≤ 30 days prior to screening
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
El Paso Eye Surgeons
El Paso, Texas, 79902
Vold Vision
Fayetteville, Arkansas, 72704
Ophthalmology Associates
Fort Worth, Texas, 76102
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104
Coastal Vision Medical Group
Orange, California, 92868
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Multi-Center Prospective Randomized Controlled Study of the Safety and Effectiveness of the Sight Sciences VISCO™360 System in Canaloplasty vs Selective Laser Trabeculoplasty in the Reduction of IOP in Primary Open Angle Glaucoma
The purpose of this study is to evaluate the safety and effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in reducing intraocular pressure (IOP) in adult, pseudophakic subjects with open-angle glaucoma.
Read the detailed description
This is a randomized study comparing viscodilation with the VISCO360 device to selective laser trabeculoplasty. Subjects with mild to moderate primary open-angle glaucoma undergo IOP-lowering medication washout at baseline and at Month 12. Subjects will be followed through Month 24.
- Conditions
- Open-Angle Glaucoma
- Being tested
- VISCO360 ab interno canaloplasty surgery, Selective Laser Trabeculoplasty (SLT)
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VISCO360 ab interno canaloplasty surgeryDevice
360 degrees of viscodilation of Schlemm's canal
Selective Laser Trabeculoplasty (SLT)Device
360 degrees of selective laser trabeculoplasty
| Study group | Role | What they receive |
|---|---|---|
| VISCO360 ab interno canaloplasty surgery | Active comparator | Subjects randomized to this arm will undergo a surgical procedure in which the VISCO360 Viscosurgical System will be used to microcatheterize and viscodilate Schlemm's canal (i.e., canaloplasty). Receives: Device: VISCO360 ab interno canaloplasty surgery |
| Selective Laser Trabeculoplasty (SLT) | Active comparator | Subjects randomized to this arm will undergo the SLT procedure. Receives: Device: Selective Laser Trabeculoplasty (SLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Diurnal IOP at 12 Months (Measured in mm Hg)
The mean of the difference between the baseline DIOP and the 12 month DIOP for each subject. Measurements at baseline and 12 months are following wash-out of glaucoma medication.
Measured: 12 months
Secondary outcomes (1)
Proportion of Subjects Achieving a ≥ 20% Change in Mean Diurnal IOP at 12 Months
Measurement is performed at 12 months following wash-out of glaucoma medication and is the number of subjects with 12 month DIOP that is at least 20% lower than the baseline DIOP divided by the number of subjects and multiplied by 100.
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 posted10 Oct 2016 (estimated)
- Study start23 Jan 2017
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Why it stopped: Poor enrollment
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open-Angle 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sight Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne-Marie Ripley, Study director, Sight Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928289
- Sponsor's protocol ID
- SIGHTVISCO-001
- Status last verified
- Oct 2025
- First submitted
- 6 Oct 2016
- Last updated
- 14 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
PubMed 35943114
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Prospective Randomized Controlled Study of the Safety and Effectiveness of the Sight Sciences VISCO™360 System in Canaloplasty vs Selective Laser Trabeculoplasty in the Reduction of IOP in Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT02928289
- Acronym / sponsor ID
- SIGHTVISCO-001
- Conditions
- Open-Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Sight Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Posted 24 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in reducing intraocular pressure (IOP) in adult, pseudophakic subjects with open-angle glaucoma.
Detailed description
This is a randomized study comparing viscodilation with the VISCO360 device to selective laser trabeculoplasty. Subjects with mild to moderate primary open-angle glaucoma undergo IOP-lowering medication washout at baseline and at Month 12. Subjects will be followed through Month 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VISCO360 ab interno canaloplasty surgery | Active comparator | Device: VISCO360 ab interno canaloplasty surgerySubjects randomized to this arm will undergo a surgical procedure in which the VISCO360 Viscosurgical System will be used to microcatheterize and viscodilate Schlemm's canal (i.e., canaloplasty). |
| Selective Laser Trabeculoplasty (SLT) | Active comparator | Device: Selective Laser Trabeculoplasty (SLT)Subjects randomized to this arm will undergo the SLT procedure. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with primary open-angle glaucoma (POAG) in the study eye.
- Pseudophakic with Posterior Chamber IOL (PCIOL)
- Able and willing to attend follow up visits for two years post-operative
- Able and willing to sign informed consent
Key exclusion criteria (6 listed)
- Phakia or aphakia
- Previous glaucoma procedure with or without an implantable glaucoma device (including incisional surgery, ALT, iridectomy/iridotomy, etc.) [Subjects with one prior SLT application (>3 months prior to screening) or prior ECP (performed > 12 months prior to screening) can be enrolled].
- Use of more than 3 ocular hypotensive medications (combination medications count as 2 medications)
- Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma
- Abnormal angle anatomy as determined by gonioscopy (e.g. peripheral anterior synechiae, rubeosis or other angle abnormalities)
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 |
|---|---|---|
| VISCO360 ab interno canaloplasty surgery360 degrees of viscodilation of Schlemm's canal | Device | VISCO360 ab interno canaloplasty surgery |
| Selective Laser Trabeculoplasty (SLT)360 degrees of selective laser trabeculoplasty | Device | Selective Laser Trabeculoplasty (SLT) |
Primary outcome
Mean Change From Baseline in Diurnal IOP at 12 Months (Measured in mm Hg)
Time frame: 12 months
The mean of the difference between the baseline DIOP and the 12 month DIOP for each subject. Measurements at baseline and 12 months are following wash-out of glaucoma medication.
1 secondary outcome
Proportion of Subjects Achieving a ≥ 20% Change in Mean Diurnal IOP at 12 Months
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 14 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35943114Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
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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.
Anne-Marie Ripley study director
Sight Sciences, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VISCO360 ab interno canaloplasty surgery and Selective Laser Trabeculoplasty (SLT) in people with Open-Angle Glaucoma, run by Sight Sciences, Inc. at 6 sites in United States.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 24 Sep 2025). 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 Change From Baseline in Diurnal IOP at 12 Months (Measured in mm Hg) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02928289, which also lists 1 linked publication.
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 14 Nov 2025.