Clinical trial NCT06933836: DSLT Performance in Treatment-naïve Patients With Newly Diagnosed Open Angle Glaucoma
Official title: How Does First Line Treatment With DSLT Perform in Treatment-naïve Patients With Newly Diagnosed Primary Open Angle Glaucoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Open Angle Glaucoma (OAG)
Keywords: Glaucoma
DSLT
Interocular Pressure
Lead sponsor: Barnet Dulaney Perkins Eye Centers
Sponsor class: NETWORK
Collaborators: name: Alcon, a Novartis Company
First posted: 2025-04-18
Enrollment: 55
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 55 Treatment naïve (including medication in either eye, previous laser or surgery) mild to moderate POAG subjects

Brief summary: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Success of IOP Reduction Through DSLT Utilization
timeFrame: 12 months
Secondary outcomes:
measure: Other Improvements to Disease State through DSLT Treatment
timeFrame: 12 months
measure: Other Improvements to Disease State through DSLT Treatment
timeFrame: 12 months
measure: Other Improvements to Disease State through DSLT Treatment
timeFrame: 12 months
measure: Other Improvements to Disease State through DSLT Treatment
timeFrame: 12 months
measure: Other Improvements to Disease State through DSLT Treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Barnet Dulaney Perkins Eye Centers
state: Arizona
Study officials:
affiliation: Barnet Dulaney Perkins Eye Centers
name: Christine Funke, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Radcliffe N. Direct Selective Laser Trabeculoplasty. Expanding Access to and Delivery of SLT Poses a Great Challenge. Glaucoma Today. 2022.
citation: 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.
citation: 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.
citation: 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.
citation: 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.