Pseudoexfoliation Glaucoma
Conditions
Brief summary
Prospective, multi-center, single arm, interventional study evaluating DSLT in patients with pseudoexfoliative glaucoma.
Interventions
A non-invasive laser procedure for treating glaucoma and ocular hypertension by improving the eye's natural fluid drainage
Sponsors
Vance Thompson Vision
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effective Endpoint | 6 months | Proportion of eyes achieving ≥20% reduction in washed-out IOP at month 6 compared to washed-out baseline IOP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Effective Endpoint | 12 months | Proportion of eyes achieving ≥ 20% reduction in washed out IOP at month 12 compared to washed-out baseline IOP |
Countries
United States
Contacts
CONTACTLorraine Provencher, MD
CONTACTDana Dubas
Outcome results
None listed