Health TrialsbyHealthPanel

IOP Reduction in Pigmentary Glaucoma Using DSLT

ConditionsPigmentary Dispersion SyndromePigmentary Dispersion Glaucoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMann Eye Institute

About this trial

This study is a single-site, single-arm, prospective, observational study of IOP reduction after DSLT. Subjects will be assessed up to 12 months post-operatively. Clinical evaluations will include IOP and number of glaucoma medications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients with pigmentary dispersion syndrome with elevated IOP or mild to moderate (based on AAO Preferred Practice Program criteria) pigmentary glaucoma with glaucomatous optic neuropathy and corresponding visual field/RNFL loss.

Treatment naive, or washed out IOP ranging from ≥18-34 mmHg

Central corneal thickness (CCT) 480-600 µm

Able to complete medication washout and follow-up

Disqualifiers

Prior incisional glaucoma surgery or glaucoma-related procedures in the study eye

Prior laser trabeculoplasty <3 years

Prior intraocular surgery and refractive surgery, except for cataract surgery unless greater than 2 years

Patients anticipating cataract surgery within the follow-up period

Trial population

Eligible test subjects will be adult patients with pigmentary dispersion syndrome with elevated IOP or mild to moderate (based on AAO Preferred Practice Program criteria) pigmentary glaucoma with glaucomatous optic neuropathy and corresponding visual field/RNFL loss.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Voyager DSLT

    Device

    DSLT is an innovative adaptation of traditional SLT. Rather than using a gonioscopic lens, DSLT applies laser energy directly through the limbus to the trabecular meshwork in a few seconds.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Mean washed-out IOP change post-DSLT compared to washed-out baseline IOP

Time frame
6 months post-DSLT

Secondary outcomes

1

Complete success: proportion of eyes with ≥ 20% washed out IOP reduction post-DSLT without secondary interventions (additional medications or procedures) compared with washed out baseline IOP

Time frame
6 months post-DSLT
2

Complete success: proportion of eyes with ≥ 20% washed out IOP reduction post-DSLT without secondary interventions (additional medications or procedures) compared with washed out baseline IOP

Time frame
12 months post-DSLT
3

Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications

Time frame
6 months post-DSLT
4

Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications

Time frame
12 months post-DSLT

Other outcomes

Sponsors and contacts

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

Mann Eye Institute

Lead sponsor

Sengi

Collaborator

Source ClinicalTrials.gov
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