Clinical trial NCT03395535: Laser-1st vs Drops-1st for Glaucoma and Ocular Hypertension
Official title: Health-Related Quality of Life in Two Pathways for Newly Diagnosed Open Angle Glaucoma and Ocular Hypertension: an Unmasked, Multi-centre, Randomised Controlled Trial of Initial Selective Laser Trabeculoplasty Versus Medical Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Keywords: Primary Open Angle Glaucoma
Glaucoma
Ocular Hypertension
POAG
SLT
Laser
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 718
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 laser ('Medicine-1st'). It compares quality of life in the two arms at three years, while also examining the incremental cost and cost-effectiveness of Laser-1st versus Medicine-1st.

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 conventional medical therapy as required' ('Laser-1st') and 'medical therapy without laser ('Medicine-1st'). We compare quality of life in the two pathways (arms) over three years, while also examining the incremental cost and cost-effectiveness of Laser-1st versus Medicine-1st.

A 'Treat in Pursuit of Control' design (TPC) compares two different routes to a pre-defined target Intraocular pressure (IOP) (pathways). It is a pragmatic study that uses published guidelines to make the complex clinical treatment choices faced in managing glaucoma, standardised between treatment arms by use of computer treatment algorithms. A UK National Institute for Health and care Excellence (NICE)-compliant evidence-based IOP Treatment Target 1 is set for each patient, according to the study treatment algorithms. They then proceed through stepped increments of treatment intensity (up to and including surgery) until a predetermined Target IOP is reached. Target IOP is reassessed in the light of objective clinical evidence of stability of glaucomatous optic neuropathy (GON) and visual function using visual field tests and automated optic nerve evaluation. Health Related Quality of Life (HRQL) and secondary outcomes are compared for patients in each pathway.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Health Related Quality of Life using EQ-5D
timeFrame: 3 years
Secondary outcomes:
measure: Health Related Quality of Life using GUI
timeFrame: 3 years
measure: Cost-effectiveness ratio
timeFrame: 3 years
measure: Cost-effectiveness
timeFrame: 3 years
measure: Glaucoma Symptom Score (GSS)
timeFrame: 3 years
measure: Glaucoma Quality of Life-15 (GQL-15)
timeFrame: 3 years
measure: Glaucoma Utility Index (GUI)
timeFrame: 3 years
measure: Visual Acuity
timeFrame: 3 years
measure: Humphrey Visual Field Assessments
timeFrame: 3 years
measure: Heidelberg Retinal Tomographie optic nerve analysis
timeFrame: 3 years
measure: Goldmann Applanation Tonometry measured intra-ocular pressure
timeFrame: 3 years
measure: Hospital visit frequency
timeFrame: 3 years
measure: Treatment intensity
timeFrame: 3 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
Study officials:
affiliation: Moorfields Eye Hospital / UCL BRC
name: Gus Gazzard, MA FRCOphth
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vickerstaff V, Ambler G, Bunce C, Xing W, Gazzard G; LiGHT Trial Study Group. Statistical analysis plan for the Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial (LiGHT): a multi-centre randomised controlled trial. Trials. 2015 Nov 11;16:517. doi: 10.1186/s13063-015-1047-9.
citation: Gazzard G, Konstantakopoulou E, Garway-Heath D, Barton K, Wormald R, Morris S, Hunter R, Rubin G, Buszewicz M, Ambler G, Bunce C; LiGHT Trial Study Group. Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology. Br J Ophthalmol. 2018 May;102(5):593-598. doi: 10.1136/bjophthalmol-2017-310877. Epub 2017 Sep 13.
citation: Konstantakopoulou E, Gazzard G, Vickerstaff V, Jiang Y, Nathwani N, Hunter R, Ambler G, Bunce C; LiGHT Trial Study Group. The Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre randomised controlled trial: baseline patient characteristics. Br J Ophthalmol. 2018 May;102(5):599-603. doi: 10.1136/bjophthalmol-2017-310870. Epub 2017 Oct 5.