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The Laser in Pseudoexfoliation (LIP) Study

Phase 4
Withdrawn
Conditions
Glaucoma
Registration Number
NCT01704989
Lead Sponsor
Nova Scotia Health Authority
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Inclusion Criteria:<br><br> - Evidence of PXF material on the anterior chamber structures by slit lamp<br> biomicroscopy.<br><br> - An open drainage angle with no irido-trabecular contact on non-indentation<br> gonioscopy in primary position trabecular meshwork visible over 360 degrees.<br><br> - Ocular hypertension or glaucoma deemed to require treatment by the attending<br> clinician.<br><br> - A decision to treat has been made by a Consultant Glaucoma Specialist.<br><br> - Age over 18 years and able to provide informed consent.<br><br>Exclusion Criteria:<br><br> - Advanced glaucoma as determined by EMGT criteria 1: visual field loss mean deviation<br> worse than -12 dB in the better or -15 dB in the worse eye.<br><br> - Co-existing other secondary glaucoma (e.g. pigment dispersion syndrome, rubeosis<br> etc) or angle closure glaucoma.<br><br> - History of retinal ischaemia, macular oedema or diabetic retinopathy.<br><br> - Age-related macular degeneration with neovascularisation or geographic atrophy and<br> VA worse than 6/36.<br><br> - Any previous intra-ocular surgery, except uncomplicated phacoemulsification at least<br> one year before.* Medically unfit for completion of the trial.

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of drops (and surgical interventions) needed to reach target IOP.;Percentage success
Secondary Outcome Measures
NameTimeMethod
Correlation of angle pigment grade with IOP reduction from SLT;Comparison of percentage success and number of drops in current study with the equivalent results of patients with POAG in the LiGHT study;Number of progressing patients in each study arm (SLT or medical therapy) in terms of visual field loss and HRT.
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