Health TrialsbyHealthPanel

The Safety and Efficacy of Direct SLT in Pseudoexfoliation Glaucoma

ConditionPseudoexfoliation Glaucoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorVance Thompson Vision

About this trial

Prospective, multi-center, single arm, interventional study evaluating DSLT in patients with pseudoexfoliative glaucoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Direct selective laser trabeculoplasty

    Device

    A non-invasive laser procedure for treating glaucoma and ocular hypertension by improving the eye's natural fluid drainage

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Treated GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

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
2

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
3

Secondary Effective Endpoint

Change in # of glaucoma medication(s) at 6 and 12 months

Time frame
6 and 12 months
4

Secondary Effective Endpoint

Proportion of medication free eyes post-DSLT at 6 and 12 months

Time frame
6 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vance Thompson Vision

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: