DSLT Performance in Treatment-naïve Patients With Newly Diagnosed Open Angle Glaucoma

NCT06933836 | Recruiting

• 1 other identifier: Alcon - IIT Proposal 95645649
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

DSLT demonstrates a ≥ 20% reduction of IOP from pre-treatment baseline in POAG patients naïve of previous glaucoma treatment at 12 months.

Conditions

Open Angle Glaucoma (OAG)

Keywords

Glaucoma; DSLT; Interocular Pressure

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (5)

• Other Improvements to Disease State through DSLT Treatment

  12 months

• Other Improvements to Disease State through DSLT Treatment

  12 months

• Other Improvements to Disease State through DSLT Treatment

  12 months

• Other Improvements to Disease State through DSLT Treatment

  12 months

• Other Improvements to Disease State through DSLT Treatment

  12 months

Study Arms (1)

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

Device: DSLT enables newly diagnosed patients to remain well controlled and off medications

Interventions

DSLT enables newly diagnosed patients to remain well controlled and off medications DEVICE

DSLT enables newly diagnosed patients to remain well controlled and off medications

Treatment naïve (including medication in either eye, previous laser or surgery) mild to moderate POA

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

55 Treatment naïve (including medication in either eye, previous laser or surgery) mild to moderate POAG subjects

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Barnet Dulaney Perkins Eye Centers: lead
• Alcon, a Novartis Company: collaborator

Study Sites (1)

Barnet Dulaney Perkins Eye Centers

Mesa, Arizona, 85206, United States

RECRUITING

Related Publications (5)

• Radcliffe N. Direct Selective Laser Trabeculoplasty. Expanding Access to and Delivery of SLT Poses a Great Challenge. Glaucoma Today. 2022.

  BACKGROUND

• 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.

  PMID: 37702635 BACKGROUND

• Narayanaswamy 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.

  PMID: 25429421 BACKGROUND

• Gazzard 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.

  PMID: 30862377 BACKGROUND

• Latina 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.

  PMID: 7789416 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Christine Funke, Medical Doctor

  Barnet Dulaney Perkins Eye Centers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Derek J Arnson, Master of Education

CONTACT

4804201005; derek.arnson@researchavp.com

Christine Funke, Medical Doctor

CONTACT

4804201005; christine.funke@BDPEC.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: April 18, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data will be available after the study is completed tentatively 12/2026 and available for 12 months until 12/2027.
• Access Criteria: The investigators will allow other researchers to contact us for information and the study results, the final results is the only thing that others will have access to upon request.

Locations

US (1)