Ocular Hypertension Clinical Trial
— LIGHTOfficial 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
Verified date | January 2018 |
Source | Moorfields Eye Hospital NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 718 |
Est. completion date | December 25, 2017 |
Est. primary completion date | December 25, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Moorfields Eye Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Moorfields Eye Hospital NHS Foundation Trust |
United Kingdom,
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. 2017 Sep 13. pii: bjophthalmol-2017-310877. doi: 10.1136/bjophthalmol-2017-310877. [Epub ahead of print] — View 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. 2017 Oct 5. pii: bjophthalmol-2017-310870. doi: 10.1136/bjophthalmol-2017-310870. [Epub ahead of print] — View 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. Erratum in: Trials. 2017 Jul 11;18(1):318. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Health Related Quality of Life using EQ-5D | Quality Adjusted Life Years by EQ-5D health states | 3 years | |
Secondary | Health Related Quality of Life using GUI | Glaucoma-specific treatment-related quality of life: Glaucoma Utility Index (GUI) | 3 years | |
Secondary | Cost-effectiveness ratio | Incremental Cost Effectiveness Ratio | 3 years | |
Secondary | Cost-effectiveness | Cost per Quality Adjusted Life Year (QALY) | 3 years | |
Secondary | Glaucoma Symptom Score (GSS) | Disease and treatment-related symptom score (patient reported outcome, PROM) | 3 years | |
Secondary | Glaucoma Quality of Life-15 (GQL-15) | Patient Reported Visual Function Score (patient reported outcome, PROM) | 3 years | |
Secondary | Glaucoma Utility Index (GUI) | Disease-Specific Utility Score (patient reported outcome, PROM) | 3 years | |
Secondary | Visual Acuity | Visual Function measured using LogMAR acuity. | 3 years | |
Secondary | Humphrey Visual Field Assessments | Visual Function measured using Mean Deviation | 3 years | |
Secondary | Heidelberg Retinal Tomographie optic nerve analysis | Optic nerve structure, measured in mean near-retinal rim width. | 3 years | |
Secondary | Goldmann Applanation Tonometry measured intra-ocular pressure | Clinical outcome of intra-ocular pressure lowering, mmHg. | 3 years | |
Secondary | Hospital visit frequency | Objective measures of treatment pathway efficacy, measured by number of hospital visits in two treatment arms over trial period. | 3 years | |
Secondary | Treatment intensity | Objective measures of treatment pathway efficacy, measured by number of medications used in two treatment arms over trial period. | 3 years |
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