The Laser in Pseudoexfoliation (LIP) Study (NCT01704989) | Clinical Trial Compass
WithdrawnPhase 4
The Laser in Pseudoexfoliation (LIP) Study
Stopped: Did not submit to the REB
Canada0Started 2012-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of drops (and surgical interventions) needed to reach target IOP.
Timeframe: Change in IOP at 6 months, 12 months and 2 years (from baseline).