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

Phase 4

Completed

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Interventions: Procedure: Primary Selective Laser Trabeculoplasty Treatment Pathway; Drug: Primary Medical Treatment Pathway

• Registration Number: NCT03395535
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

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.

Study Timeline

• Study Start: 2012-10-01
• Study First Submitted: 2013-05-24
• Primary Completion: 2017-12-25
• Study Completion: 2017-12-25
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-09
• Last Update Submitted: 2018-01-09
• Study First Posted: 2018-01-10
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 718

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
'Laser-1st'	Primary Selective Laser Trabeculoplasty Treatment Pathway	Initial Selective Laser Trabeculoplasty (SLT) \[PROCEDURE\] followed by conventional medical therapy (eye-drops) as required. All participants in this arm start their treatment pathway with SLT. If this does not reach the predefined, patient-specific target IOP then repeat laser (once only) is given. If the IOP target is then not reached additional treatment with all standard medications may be used and ultimately surgery (trabeculectomy with mitomycin C) as needed.
Medicine-1st	Primary Medical Treatment Pathway	Conventional medical therapy \[DRUG\] without laser. All participants in this arm start their treatment pathway medical treatment. If the IOP target is then not reached, additional treatment with all standard medications may be used and ultimately surgery (trabeculectomy with mitomycin C) as needed. During this pathway of treatment all commercially available medical treatments (eye-drops) are permitted according to a pre-specified step-wise 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.

Primary Outcome Measures

Name	Time	Method
Health Related Quality of Life using EQ-5D	3 years	Quality Adjusted Life Years by EQ-5D health states

Secondary Outcome Measures

Name	Time	Method
Humphrey Visual Field Assessments	3 years	Visual Function measured using Mean Deviation
Health Related Quality of Life using GUI	3 years	Glaucoma-specific treatment-related quality of life: Glaucoma Utility Index (GUI)
Cost-effectiveness ratio	3 years	Incremental Cost Effectiveness Ratio
Cost-effectiveness	3 years	Cost per Quality Adjusted Life Year (QALY)
Glaucoma Symptom Score (GSS)	3 years	Disease and treatment-related symptom score (patient reported outcome, PROM)
Glaucoma Utility Index (GUI)	3 years	Disease-Specific Utility Score (patient reported outcome, PROM)
Visual Acuity	3 years	Visual Function measured using LogMAR acuity.
Heidelberg Retinal Tomographie optic nerve analysis	3 years	Optic nerve structure, measured in mean near-retinal rim width.
Goldmann Applanation Tonometry measured intra-ocular pressure	3 years	Clinical outcome of intra-ocular pressure lowering, mmHg.
Hospital visit frequency	3 years	Objective measures of treatment pathway efficacy, measured by number of hospital visits in two treatment arms over trial period.
Treatment intensity	3 years	Objective measures of treatment pathway efficacy, measured by number of medications used in two treatment arms over trial period.
Glaucoma Quality of Life-15 (GQL-15)	3 years	Patient Reported Visual Function Score (patient reported outcome, PROM)

Trial Locations

Locations (1)

Moorfields Eye Hospital; 🇬🇧 London, United Kingdom