Laser-1st vs Drops-1st for Glaucoma and Ocular Hypertension

Ocular Hypertension Clinical Trial

— LIGHT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395535
• Other study ID #: GAZG1001
• Secondary ID: HTA 09/104/40 -
• Status: Completed
• Phase: Phase 4
• First received: May 24, 2013
• Last updated: January 9, 2018
• Start date: October 1, 2012
• Est. completion date: December 25, 2017

Study information

• Verified date: January 2018
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open Angle Glaucoma

Intervention

Procedure:
• Primary Selective Laser Trabeculoplasty Treatment Pathway
Primary Selective Laser Trabeculoplasty Treatment (followed by medications as required) Pathway. First treatment is SLT, 100 shots of laser over 360 degrees. If this does not reach the target IOP then repeat laser (once only) is given. If IOP not at target additional treatment with all standard medications may be used and ultimately surgery (trabeculectomy ). All available medical treatments (eye-drops) are permitted according to a pre-specified intervention protocol described in detail in the publicly available trial protocol. This begins with prostaglandin analogues, then beta-blockers followed by alpha agonists or carbonic anhydrase inhibitors. The full range of available doses, treatments and drugs is beyond this short summary.

Drug:
• Primary Medical Treatment Pathway
Primary Medical Treatment Pathway (multiple medications, as required). If IOP not at target additional treatment with all standard medications may be used and ultimately surgery (trabeculectomy ). All available medical treatments (eye-drops) are permitted according to a pre-specified intervention protocol described in detail in the publicly available trial protocol. This begins with prostaglandin analogues, then beta-blockers followed by alpha agonists or carbonic anhydrase inhibitors. The full range of available doses, treatments and drugs is beyond this short summary.

Locations

Country	Name	City	State
United Kingdom	Moorfields Eye Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Moorfields Eye Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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

Outcome

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

External Links

•   Sponsor website