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

NCT03395535 | Completed Phase 4 DMC

• 3 other identifiers: GAZG1001HTA 09/104/40 - LiGHTISRCTN 32038223
• Study Type: interventional
• Target: 718
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open Angle Glaucoma; Ocular Hypertension

Keywords

Primary Open Angle Glaucoma; Glaucoma; Ocular Hypertension; POAG; SLT; Laser

Outcome Measures

Primary Outcomes (1)

• Health Related Quality of Life using EQ-5D

  Quality Adjusted Life Years by EQ-5D health states

  3 years

Secondary Outcomes (12)

• Health Related Quality of Life using GUI

  3 years

• Cost-effectiveness ratio

  3 years

• Cost-effectiveness

  3 years

• Glaucoma Symptom Score (GSS)

  3 years

• Glaucoma Quality of Life-15 (GQL-15)

  3 years

Study Arms (2)

'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.

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.

Drug: Primary Medical Treatment Pathway

Interventions

Primary Selective Laser Trabeculoplasty Treatment Pathway PROCEDURE

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.

Also known as: SLT; "Laser First"

'Laser-1st'

Primary Medical Treatment Pathway DRUG

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.

Also known as: Conventional medical therapy; "Medicine First"

Medicine-1st

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead

Study Sites (1)

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 26559142 BACKGROUND

• 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. 2018 May;102(5):593-598. doi: 10.1136/bjophthalmol-2017-310877. Epub 2017 Sep 13.

  PMID: 28903966 BACKGROUND

• 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. 2018 May;102(5):599-603. doi: 10.1136/bjophthalmol-2017-310870. Epub 2017 Oct 5.

  PMID: 28982956 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Gus Gazzard, MA FRCOphth

  Moorfields Eye Hospital / UCL BRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All clinical tests and outcomes are by masked observers.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CONSULTANT OPHTHALMOLOGIST

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: January 10, 2018
• Study Start: October 1, 2012
• Primary Completion: December 25, 2017
• Study Completion: December 25, 2017
• Last Updated: January 10, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: For as long as is permissible under local regulations and national law.
• Access Criteria: To Be Confirmed

Locations

GB (1)