Status:
COMPLETED
Laser-1st vs Drops-1st for Glaucoma and Ocular Hypertension
Lead Sponsor:
Moorfields Eye Hospital NHS Foundation Trust
Conditions:
Primary Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a randomized study with two treatment arms: 'initial Selective Laser Trabeculoplasty (SLT) followed by conventional medical therapy as required' ('Laser-1st') and 'medical therapy without lase...
Detailed Description
Subjects are randomly allocated to one of two treatment arms that examine treatment pathways, rather than comparing single treatments alone: 'initial Selective Laser Trabeculoplasty (SLT) followed by ...
Eligibility Criteria
Inclusion
- Diagnosis of open angle glaucoma (defined as an open drainage angle and reproducible glaucomatous visual field defects as tested by the Swedish Interactive Threshold Algorithm (SITA) algorithm on the Humphrey Visual Field or glaucomatous optic neuropathy)
- OR
- Ocular hypertension (intra-ocular pressure above 21mmHg and requiring treatment as per National Institute of Health and Care Excellence (NICE) Guidelines).
- Able to provide informed consent.
Exclusion
- Advanced glaucoma in the potentially eligible eye as determined by Early Manifest Treatment Guidelines (EMGT) criteria 77: visual field loss mean deviation worse than -12dB in the better or -15dB in the worse eye.
- Secondary glaucoma (e.g. pigment dispersion syndrome, rubeosis, trauma etc) or any angle closure.
- Any contra-indication to selective laser trabeculoplasty (e.g. unable to sit at the laser-mounted slit-lamp; past history of uveitis).
- Unable to use topical medical therapy due to e.g. physical infirmity and a lack of carers able to administer daily eye-drops.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 25 2017
Estimated Enrollment :
718 Patients enrolled
Trial Details
Trial ID
NCT03395535
Start Date
October 1 2012
End Date
December 25 2017
Last Update
January 10 2018
Active Locations (1)
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1
Moorfields Eye Hospital
London, United Kingdom, EC1V 2PD