Prospective, multi-center, single arm, interventional study evaluating DSLT in patients with pseudoexfoliative glaucoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
A non-invasive laser procedure for treating glaucoma and ocular hypertension by improving the eye's natural fluid drainage
Vance Thompson Vision
Alexandria, Minnesota, United States
Vance Thompson Vision
Omaha, Nebraska, United States
Vance Thompson Vision
Fargo, North Dakota, United States
Primary Effective Endpoint
Proportion of eyes achieving ≥20% reduction in washed-out IOP at month 6 compared to washed-out baseline IOP
Time frame: 6 months
Secondary Effective Endpoint
Proportion of eyes achieving ≥ 20% reduction in washed out IOP at month 12 compared to washed-out baseline IOP
Time frame: 12 months
Secondary Effective Endpoint
Mean washed out IOP reduction at 6 and 12 months as compared to washed-out baseline IOP
Time frame: 6 and 12 months
Secondary Effective Endpoint
Change in # of glaucoma medication(s) at 6 and 12 months
Time frame: 6 and 12 months
Secondary Effective Endpoint
Proportion of medication free eyes post-DSLT at 6 and 12 months
Time frame: 6 and 12 months
Secondary Effective Endpoint
Rate of secondary surgical interventions (SSIs) at 12 months
Time frame: 12 months
Secondary Effective Endpoint
Kaplan-Meier survival analysis at 12 months: time to failure (failure defined as an increase in glaucoma medications from baseline or additional IOP lowering procedure)
Time frame: 12 months
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