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Laser-1st vs Drops-1st for Glaucoma and Ocular Hypertension (LIGHT)

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ClinicalTrials.gov Identifier: NCT03395535
Recruitment Status : Completed
First Posted : January 10, 2018
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Mr Gus Gazzard, 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.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Ocular Hypertension Procedure: Primary Selective Laser Trabeculoplasty Treatment Pathway Drug: Primary Medical Treatment Pathway Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 718 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Masking Description: All clinical tests and outcomes are by masked observers.
Primary Purpose: Treatment
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 Start Date : October 1, 2012
Primary Completion Date : December 25, 2017
Study Completion Date : December 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 'Laser-1st'

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.

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.

Other Name: SLT; "Laser First"
Active Comparator: Medicine-1st

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.

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.

Other Name: Conventional medical therapy; "Medicine First"



Primary Outcome Measures :
  1. Health Related Quality of Life using EQ-5D [ Time Frame: 3 years ]
    Quality Adjusted Life Years by EQ-5D health states


Secondary Outcome Measures :
  1. Health Related Quality of Life using GUI [ Time Frame: 3 years ]
    Glaucoma-specific treatment-related quality of life: Glaucoma Utility Index (GUI)

  2. Cost-effectiveness ratio [ Time Frame: 3 years ]
    Incremental Cost Effectiveness Ratio

  3. Cost-effectiveness [ Time Frame: 3 years ]
    Cost per Quality Adjusted Life Year (QALY)

  4. Glaucoma Symptom Score (GSS) [ Time Frame: 3 years ]
    Disease and treatment-related symptom score (patient reported outcome, PROM)

  5. Glaucoma Quality of Life-15 (GQL-15) [ Time Frame: 3 years ]
    Patient Reported Visual Function Score (patient reported outcome, PROM)

  6. Glaucoma Utility Index (GUI) [ Time Frame: 3 years ]
    Disease-Specific Utility Score (patient reported outcome, PROM)

  7. Visual Acuity [ Time Frame: 3 years ]
    Visual Function measured using LogMAR acuity.

  8. Humphrey Visual Field Assessments [ Time Frame: 3 years ]
    Visual Function measured using Mean Deviation

  9. Heidelberg Retinal Tomographie optic nerve analysis [ Time Frame: 3 years ]
    Optic nerve structure, measured in mean near-retinal rim width.

  10. Goldmann Applanation Tonometry measured intra-ocular pressure [ Time Frame: 3 years ]
    Clinical outcome of intra-ocular pressure lowering, mmHg.

  11. Hospital visit frequency [ Time Frame: 3 years ]
    Objective measures of treatment pathway efficacy, measured by number of hospital visits in two treatment arms over trial period.

  12. Treatment intensity [ Time Frame: 3 years ]
    Objective measures of treatment pathway efficacy, measured by number of medications used in two treatment arms over trial period.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395535


Locations
United Kingdom
Moorfields Eye Hospital
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust
Investigators
Principal Investigator: Gus Gazzard, MA FRCOphth Moorfields Eye Hospital / UCL BRC

Additional Information:
Publications:
Responsible Party: Mr Gus Gazzard, CONSULTANT OPHTHALMOLOGIST, Moorfields Eye Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03395535     History of Changes
Other Study ID Numbers: GAZG1001
HTA 09/104/40 - LiGHT ( Other Identifier: NIHR HTA )
ISRCTN 32038223 ( Other Identifier: ISRCTN )
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: To supply, upon request and mutually agreed terms, IPD level anonymised data where permitted by local regulations and national law.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: For as long as is permissible under local regulations and national law.
Access Criteria: To Be Confirmed

Keywords provided by Mr Gus Gazzard, Moorfields Eye Hospital NHS Foundation Trust:
Primary Open Angle Glaucoma
Glaucoma
Ocular Hypertension
POAG
SLT
Laser

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Tetrahydrozoline
Carbonic Anhydrase Inhibitors
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action