Open Angle Glaucoma (OAG)NCT06933836
DSLT Performance in Treatment-naïve Patients With Newly Diagnosed Open Angle Glaucoma
An observational study of Open Angle Glaucoma (OAG), run by Barnet Dulaney Perkins Eye Centers at 1 site in United States.
Trial summary
DSLT demonstrates a ≥ 20% reduction of IOP from pre-treatment baseline in POAG patients naïve of previous glaucoma treatment at 12 months. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Open Angle Glaucoma (OAG)
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 55 Treatment naïve (including medication in either eye, previous laser or surgery) mild to moderate POAG subjects
Who may be able to join
- Primary open angle glaucoma
- Patients age 30 or greater with an IOP of 18-26 mmHg
- Mild to moderate POAG patients (mild or moderate according to the AAO PPP Guidelines)
- DSLT procedure
Who cannot join
- History of prior glaucoma treatment - this includes past medication use (in either eye), previous lasers or incisional surgery
- Angle closure patients
- Ocular Hypertension
- Baseline VF MD of worse than -12dB
- Uncontrolled systemic microvascular disease (eg. HTN, DM)
- Subjects with peri-limbal findings (e.g. melanosis, tumors, extensive pterygium, significant senile arcus and pterygium)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Barnet Dulaney Perkins Eye Centers
Mesa, Arizona, 85206
Derek J Arnson, Master of Education, 4804201005, derek.arnson@researchavp.com
Christine Funke, Medical Doctor, 4804201005, christine.funke@BDPEC.com
About this study
Official title: How Does First Line Treatment With DSLT Perform in Treatment-naïve Patients With Newly Diagnosed Primary Open Angle Glaucoma
DSLT demonstrates a ≥ 20% reduction of IOP from pre-treatment baseline in POAG patients naïve of previous glaucoma treatment at 12 months.
Read the detailed description
DSLT enables newly diagnosed patients to remain well controlled and off medications
- Conditions
- Open Angle Glaucoma (OAG)
- Being tested
- DSLT enables newly diagnosed patients to remain well controlled and off medications
- Keywords
- Glaucoma, DSLT, Interocular Pressure
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSLT enables newly diagnosed patients to remain well controlled and off medicationsDevice
DSLT enables newly diagnosed patients to remain well controlled and off medications
| Study group | Role | What they receive |
|---|---|---|
| Treatment naïve (including medication in either eye, previous laser or surgery) mild to moderate POA | (including medication in either eye, previous laser or surgery) mild to moderate POA Receives: Device: DSLT enables newly diagnosed patients to remain well controlled and off medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of IOP Reduction Through DSLT Utilization
Proportion of patients (%) with DSLT success as defined as IOP lowering of >20% and no additional medications or procedures at 12 months.
Measured: 12 months
Secondary outcomes (5)
Other Improvements to Disease State through DSLT Treatment
- Change in mean deviation.. (dB)
Measured: 12 months
Other Improvements to Disease State through DSLT Treatment
- Change in RNFL /GCA (µm)
Measured: 12 months
Other Improvements to Disease State through DSLT Treatment
- Overall IOP reduction (mmHG)
Measured: 12 months
Other Improvements to Disease State through DSLT Treatment
- Medication reduction (#0-5)
Measured: 12 months
Other Improvements to Disease State through DSLT Treatment
- SSIs (% on trabeculectomy, glaucoma drainage implant (GDI), other)
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 posted18 Apr 2025
- Study start31 Mar 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Open Angle Glaucoma (OAG)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barnet Dulaney Perkins Eye Centers
- Sponsor type
- Research network
- Collaborators
- Alcon, a Novartis Company
- Responsible party
- Sponsor
- Investigators
- Christine Funke, Medical Doctor, Principal investigator, Barnet Dulaney Perkins Eye Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933836
- Sponsor's protocol ID
- Alcon - IIT Proposal 95645649
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of the study collection, the investigators will share the findings of the DSLT treatment with other researchers to then be published
Publications
Radcliffe N. Direct Selective Laser Trabeculoplasty. Expanding Access to and Delivery of SLT Poses a Great Challenge. Glaucoma Today. 2022.
Takusagawa HL, Hoguet A, Sit AJ, Rosdahl JA, Chopra V, Ou Y, Richter G, Kim SJ, WuDunn D. Selective Laser Trabeculoplasty for the Treatment of Glaucoma: A Report by the American Academy of Ophthalmology. Ophthalmology. 2024 Jan;131(1):37-47. doi: 10.1016/j.ophtha.2023.07.029. Epub 2023 Sep 14.
PubMed 37702635Narayanaswamy A, Leung CK, Istiantoro DV, Perera SA, Ho CL, Nongpiur ME, Baskaran M, Htoon HM, Wong TT, Goh D, Su DH, Belkin M, Aung T. Efficacy of selective laser trabeculoplasty in primary angle-closure glaucoma: a randomized clinical trial. JAMA Ophthalmol. 2015 Feb;133(2):206-12. doi: 10.1001/jamaophthalmol.2014.4893.
PubMed 25429421Gazzard G, Konstantakopoulou E, Garway-Heath D, Garg A, Vickerstaff V, Hunter R, Ambler G, Bunce C, Wormald R, Nathwani N, Barton K, Rubin G, Buszewicz M; LiGHT Trial Study Group. Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial. Lancet. 2019 Apr 13;393(10180):1505-1516. doi: 10.1016/S0140-6736(18)32213-X. Epub 2019 Mar 9.
PubMed 30862377Latina MA, Park C. Selective targeting of trabecular meshwork cells: in vitro studies of pulsed and CW laser interactions. Exp Eye Res. 1995 Apr;60(4):359-71. doi: 10.1016/s0014-4835(05)80093-4.
PubMed 7789416
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does First Line Treatment With DSLT Perform in Treatment-naïve Patients With Newly Diagnosed Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT06933836
- Acronym / sponsor ID
- Alcon - IIT Proposal 95645649
- Conditions
- Open Angle Glaucoma (OAG)
- Keywords
- Glaucoma, DSLT, Interocular Pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Barnet Dulaney Perkins Eye CentersResearch network
- Collaborators
- Alcon, a Novartis Company
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DSLT demonstrates a ≥ 20% reduction of IOP from pre-treatment baseline in POAG patients naïve of previous glaucoma treatment at 12 months.
Detailed description
DSLT enables newly diagnosed patients to remain well controlled and off medications
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment naïve (including medication in either eye, previous laser or surgery) mild to moderate POA | – | Device: DSLT enables newly diagnosed patients to remain well controlled and off medications(including medication in either eye, previous laser or surgery) mild to moderate POA |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 55 Treatment naïve (including medication in either eye, previous laser or surgery) mild to moderate POAG subjects
Key inclusion criteria (4 listed)
- Primary open angle glaucoma
- Patients age 30 or greater with an IOP of 18-26 mmHg
- Mild to moderate POAG patients (mild or moderate according to the AAO PPP Guidelines)
- DSLT procedure
Key exclusion criteria (6 listed)
- History of prior glaucoma treatment - this includes past medication use (in either eye), previous lasers or incisional surgery
- Angle closure patients
- Ocular Hypertension
- Baseline VF MD of worse than -12dB
- Uncontrolled systemic microvascular disease (eg. HTN, DM)
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 |
|---|---|---|
| DSLT enables newly diagnosed patients to remain well controlled and off medicationsDSLT enables newly diagnosed patients to remain well controlled and off medications | Device | Treatment naïve (including medication in either eye, previous laser or surgery) mild to moderate POA |
Primary outcome
Success of IOP Reduction Through DSLT Utilization
Time frame: 12 months
Proportion of patients (%) with DSLT success as defined as IOP lowering of >20% and no additional medications or procedures at 12 months.
5 secondary outcomes
Other Improvements to Disease State through DSLT Treatment
Time frame: 12 months
Other Improvements to Disease State through DSLT Treatment
Time frame: 12 months
Other Improvements to Disease State through DSLT Treatment
Time frame: 12 months
Other Improvements to Disease State through DSLT Treatment
Time frame: 12 months
Other Improvements to Disease State through DSLT Treatment
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- BackgroundRadcliffe N. Direct Selective Laser Trabeculoplasty. Expanding Access to and Delivery of SLT Poses a Great Challenge. Glaucoma Today. 2022.
- Background: PubMed 37702635Takusagawa HL, Hoguet A, Sit AJ, Rosdahl JA, Chopra V, Ou Y, Richter G, Kim SJ, WuDunn D. Selective Laser Trabeculoplasty for the Treatment of Glaucoma: A Report by the American Academy of Ophthalmology. Ophthalmology. 2024 Jan;131(1):37-47. doi: 10.1016/j.ophtha.2023.07.029. Epub 2023 Sep 14.
- Background: PubMed 25429421Narayanaswamy A, Leung CK, Istiantoro DV, Perera SA, Ho CL, Nongpiur ME, Baskaran M, Htoon HM, Wong TT, Goh D, Su DH, Belkin M, Aung T. Efficacy of selective laser trabeculoplasty in primary angle-closure glaucoma: a randomized clinical trial. JAMA Ophthalmol. 2015 Feb;133(2):206-12. doi: 10.1001/jamaophthalmol.2014.4893.
- Background: PubMed 30862377Gazzard G, Konstantakopoulou E, Garway-Heath D, Garg A, Vickerstaff V, Hunter R, Ambler G, Bunce C, Wormald R, Nathwani N, Barton K, Rubin G, Buszewicz M; LiGHT Trial Study Group. Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial. Lancet. 2019 Apr 13;393(10180):1505-1516. doi: 10.1016/S0140-6736(18)32213-X. Epub 2019 Mar 9.
- Background: PubMed 7789416Latina MA, Park C. Selective targeting of trabecular meshwork cells: in vitro studies of pulsed and CW laser interactions. Exp Eye Res. 1995 Apr;60(4):359-71. doi: 10.1016/s0014-4835(05)80093-4.
- Individual participant dataSharing planned: Yes. Upon completion of the study collection, the investigators will share the findings of the DSLT treatment with other researchers to then be published
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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.
Christine Funke, Medical Doctor principal investigator
Barnet Dulaney Perkins Eye Centers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Angle Glaucoma (OAG), run by Barnet Dulaney Perkins Eye Centers at 1 site 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: looking for participants now, as of the sponsor's last update on 18 Apr 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Derek J Arnson, Master of Education (4804201005, derek.arnson@researchavp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of IOP Reduction Through DSLT Utilization (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 NCT06933836, which also lists 5 linked publications.
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 18 Apr 2025.