Primary Open Angle GlaucomaPhase 4LIGHTNCT03395535
Laser-1st vs Drops-1st for Glaucoma and Ocular Hypertension
A Phase 4 study testing Primary Selective Laser Trabeculoplasty Treatment Pathway and Primary Medical Treatment Pathway in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
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'). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Primary Selective Laser Trabeculoplasty Treatment Pathway and Primary Medical Treatment Pathway
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 718 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2012to 25 Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Primary Selective Laser Trabeculoplasty Treatment Pathway, Primary Medical Treatment Pathway
- Keywords
- Primary Open Angle Glaucoma, Glaucoma, Ocular Hypertension, POAG, SLT, Laser
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Selective Laser Trabeculoplasty Treatment PathwayProcedure or surgery
Also called SLT; "Laser First"
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.
Primary Medical Treatment PathwayDrug
Also called Conventional medical therapy; "Medicine First"
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.
| Study group | Role | What they receive |
|---|---|---|
| 'Laser-1st' | Experimental | 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. Receives: Procedure: Primary Selective Laser Trabeculoplasty Treatment Pathway |
| Medicine-1st | Active comparator | 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. Receives: Drug: Primary Medical Treatment Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life using EQ-5D
Quality Adjusted Life Years by EQ-5D health states
Measured: 3 years
Secondary outcomes (12)
Health Related Quality of Life using GUI
Glaucoma-specific treatment-related quality of life: Glaucoma Utility Index (GUI)
Measured: 3 years
Cost-effectiveness ratio
Incremental Cost Effectiveness Ratio
Measured: 3 years
Cost-effectiveness
Cost per Quality Adjusted Life Year (QALY)
Measured: 3 years
Glaucoma Symptom Score (GSS)
Disease and treatment-related symptom score (patient reported outcome, PROM)
Measured: 3 years
Glaucoma Quality of Life-15 (GQL-15)
Patient Reported Visual Function Score (patient reported outcome, PROM)
Measured: 3 years
Glaucoma Utility Index (GUI)
Disease-Specific Utility Score (patient reported outcome, PROM)
Measured: 3 years
Visual Acuity
Visual Function measured using LogMAR acuity.
Measured: 3 years
Humphrey Visual Field Assessments
Visual Function measured using Mean Deviation
Measured: 3 years
Heidelberg Retinal Tomographie optic nerve analysis
Optic nerve structure, measured in mean near-retinal rim width.
Measured: 3 years
Goldmann Applanation Tonometry measured intra-ocular pressure
Clinical outcome of intra-ocular pressure lowering, mmHg.
Measured: 3 years
Hospital visit frequency
Objective measures of treatment pathway efficacy, measured by number of hospital visits in two treatment arms over trial period.
Measured: 3 years
Treatment intensity
Objective measures of treatment pathway efficacy, measured by number of medications used in two treatment arms over trial period.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start1 Oct 2012
- Primary completion25 Dec 2017
- Study completion25 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr Gus Gazzard, Moorfields Eye Hospital NHS Foundation Trust
- Investigators
- Gus Gazzard, MA FRCOphth, Principal investigator, Moorfields Eye Hospital / UCL BRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395535
- Sponsor's protocol ID
- GAZG1001
- Other IDs
- HTA 09/104/40 - LiGHT, ISRCTN 32038223
- Acronym
- LIGHT
- Status last verified
- Jan 2018
- First submitted
- 24 May 2013
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: To supply, upon request and mutually agreed terms, IPD level anonymised data where permitted by local regulations and national law.
Publications
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.
PubMed 26559142Gazzard 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.
PubMed 28903966Konstantakopoulou 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.
PubMed 28982956
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03395535
- Acronym / sponsor ID
- LIGHT / GAZG1001
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Primary Open Angle Glaucoma, Glaucoma, Ocular Hypertension, POAG, SLT, Laser
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 718 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Oct 2012
- Primary completion
- 25 Dec 2017 (actual)
- Study completion
- 25 Dec 2017 (actual)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'Laser-1st' | Experimental | Procedure: Primary Selective Laser Trabeculoplasty Treatment PathwayInitial 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 | Active comparator | Drug: Primary Medical Treatment PathwayConventional 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Selective Laser Trabeculoplasty Treatment PathwayAlso: SLT; "Laser First"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. | Procedure or surgery | 'Laser-1st' |
| Primary Medical Treatment PathwayAlso: Conventional medical therapy; "Medicine First"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. | Drug | Medicine-1st |
Primary outcome
Health Related Quality of Life using EQ-5D
Time frame: 3 years
Quality Adjusted Life Years by EQ-5D health states
12 secondary outcomes
Health Related Quality of Life using GUI
Time frame: 3 years
Cost-effectiveness ratio
Time frame: 3 years
Cost-effectiveness
Time frame: 3 years
Glaucoma Symptom Score (GSS)
Time frame: 3 years
Glaucoma Quality of Life-15 (GQL-15)
Time frame: 3 years
Glaucoma Utility Index (GUI)
Time frame: 3 years
Visual Acuity
Time frame: 3 years
Humphrey Visual Field Assessments
Time frame: 3 years
Heidelberg Retinal Tomographie optic nerve analysis
Time frame: 3 years
Goldmann Applanation Tonometry measured intra-ocular pressure
Time frame: 3 years
Hospital visit frequency
Time frame: 3 years
Treatment intensity
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Background: PubMed 26559142Vickerstaff 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.
- Background: PubMed 28903966Gazzard 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.
- Background: PubMed 28982956Konstantakopoulou 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.
- Individual participant dataSharing planned: Yes. To supply, upon request and mutually agreed terms, IPD level anonymised data where permitted by local regulations and national law.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gus Gazzard, MA FRCOphth principal investigator
Moorfields Eye Hospital / UCL BRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Primary Selective Laser Trabeculoplasty Treatment Pathway and Primary Medical Treatment Pathway in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life using EQ-5D (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03395535, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.