The Laser in Pseudoexfoliation (LIP) Study

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A number of large clinical trials have found pseudoexfoliation (PXF) to be a major risk factor for glaucoma progression and risk of blindness. It is estimated that PXF accounts for approximately a quarter of cases of open angle glaucoma in Nova Scotia, Canada, making this region an ideal setting for studying patients with this condition. Despite associated high morbidity, the treatment of pseudoexfoliative glaucoma remains suboptimal and a challenge for the clinician. Topical medical therapy is less effective than for primary open angle glaucoma and patients often require early surgical therapy, with associated risks. Selective laser trabeculoplasty (SLT) may be a safe and effective treatment for pseudoexfoliative glaucoma, although the evidence for this is presently lacking. The aim of the current study is to provide the first controlled-trial evidence for the effectiveness of SLT, compared to topical therapy, in the management of pseudoexfoliative glaucoma.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marcelo Nicolela
• Collaborator: Dalhousie University

Criteria

Inclusion Criteria:

• Evidence of PXF material on the anterior chamber structures by slit lamp biomicroscopy.

• An open drainage angle with no irido-trabecular contact on non-indentation gonioscopy in primary position trabecular meshwork visible over 360 degrees.

• Ocular hypertension or glaucoma deemed to require treatment by the attending clinician.

• A decision to treat has been made by a Consultant Glaucoma Specialist.

• Age over 18 years and able to provide informed consent.

Exclusion Criteria:

• Advanced glaucoma as determined by EMGT criteria 1: visual field loss mean deviation worse than -12 dB in the better or -15 dB in the worse eye.

• Co-existing other secondary glaucoma (e.g. pigment dispersion syndrome, rubeosis etc) or angle closure glaucoma.

• History of retinal ischaemia, macular oedema or diabetic retinopathy.

• Age-related macular degeneration with neovascularisation or geographic atrophy and VA worse than 6/36.

• Any previous intra-ocular surgery, except uncomplicated phacoemulsification at least one year before.* Medically unfit for completion of the trial.