Not yet recruiting NCT07401290
The Safety and Efficacy of Direct SLT in Pseudoexfoliation Glaucoma
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: Direct selective laser trabeculoplasty.
- Who it may be relevant to
- Registry conditions: Pseudoexfoliation Glaucoma. Basic parameters: No limits · 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 →
Overview
Prospective, multi-center, single arm, interventional study evaluating DSLT in patients with pseudoexfoliative glaucoma.
Interventions
- Device Direct selective laser trabeculoplasty
A non-invasive laser procedure for treating glaucoma and ocular hypertension by improving the eye's natural fluid drainage
Primary outcome measures
- Primary Effective Endpoint [Time frame: 6 months]
Secondary outcome measures (6)
- Secondary Effective Endpoint [Time frame: 12 months]
- Secondary Effective Endpoint [Time frame: 6 and 12 months]
- Secondary Effective Endpoint [Time frame: 6 and 12 months]
- Secondary Effective Endpoint [Time frame: 6 and 12 months]
- Secondary Effective Endpoint [Time frame: 12 months]
- Secondary Effective Endpoint [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Adult patients diagnosed with pseudoexfoliation glaucoma (PXFG), with optic neuropathy consistent with glaucomatous damage of any severity
- Open iridocorneal angle by gonioscopy, defined as a Shafer Grade II or greater
- Treatment naive, or washed out IOP ranging from ≥18-35 mmHg
- Able to complete medication washout safely and all follow-up visits
- Participants must have a best correct visual acuity of 20/40 or better in the study eye(s), be able to undertake a reliable Humphrey visual field (HVF) (defined as fixation losses, false positives and false negatives less than 33%), and must have field loss no worse than -20 dB in treatment eye
Exclusion criteria
- Any contraindication to SLT or unable to have DSLT
- Angle closure glaucoma or any other types of glaucoma other than PXFG
- Prior incisional glaucoma surgery or glaucoma-related procedures in the study eye
- Any prior refractive surgery
- H/o LPI within last 6 months
- A history of any significant cataract required during study duration or cataract surgery in the last 6 months
- Prior laser trabeculoplasty (ALT/SLT)
- History of ocular inflammation and infection
- Patients who are pregnant or have any clinically relevant systemic disease that may prevent them from reliably completing follow-up visits
- Vulnerable populations that cannot provide proper informed consent will not be enrolled, such as children, prisoners, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Vance Thompson Vision — Alexandria
- Vance Thompson Vision — Omaha
- Vance Thompson Vision — Fargo
Identifiers
NCT: NCT07401290 · DSLT_PXFG IIT