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Recruiting NCT06933836

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

— Observational Open Angle Glaucoma (OAG)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DSLT enables newly diagnosed patients to remain well controlled and off medications.
Who it may be relevant to
Registry conditions: Open Angle Glaucoma (OAG). Basic parameters: from 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

How Does First Line Treatment With DSLT Perform in Treatment-naïve Patients With Newly Diagnosed Primary Open Angle Glaucoma

Overview

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

Interventions

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

Primary outcome measures

  • Success of IOP Reduction Through DSLT Utilization [Time frame: 12 months]
Secondary outcome measures (5)
  • 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]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Barnet Dulaney Perkins Eye Centers — Mesa

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. PMID 37702635
  • 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
  • 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/S01 PMID 30862377
  • 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

Identifiers

NCT: NCT06933836 · Alcon - IIT Proposal 95645649

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗