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

Health-Related Quality of Life in two treatment pathways for newly diagnosed open angle glaucoma (OAG) and ocular hypertension (OHT): an unmasked, multi-centre, randomised controlled trial of initial selective laser trabeculoplasty (SLT) versus conventional medical therapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN32038223
Enrollment
718
Registered
2012-07-23
Start date
2012-10-01
Completion date
Unknown
Last updated
2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma Eye Diseases Glaucoma

Interventions

Selective laser trabeculoplasty versus conventional medical therapy.

Sponsors

Moorfields Eye Hospital (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of open angle glaucoma (defined as an open drainage angle and reproducible glaucomatous visual field defects as tested by the SITA algorithm on the Humphrey Visual Field or glaucomatous optic neuropathy) 2. Or ocular hypertension (intra-ocular pressure above 21mmHg and requiring treatment as per NICE Guidelines) with a decision to treat made by a Consultant Glaucoma. Specialist. 3. Age over 18 years 4. Able to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Advanced glaucoma in the potentially eligible eye 2. Secondary glaucoma (e.g. pigment dispersion syndrome, rubeosis, trauma etc) or any angle closure 3. Any contra-indication to selective laser trabeculoplasty (e.g. unable to sit at the laser-mounted slit-lamp; past history of uveitis) 4. Unable to use topical medical therapy due to e.g. physical infirmity and a lack of carers able to administer daily eye-drops 5. Previous treatment for OAG or OHT 6. History of retinal ischaemia, macular oedema or diabetic retinopathy 7. Age-related macular degeneration with neovascularisation or geographic atrophy 8. Any previous intra-ocular surgery, except uncomplicated phaco-emulsification at least one year before. 9. Current pregnancy or intention to become pregnant within the duration of the trial 10. Medically unfit for completion of the trial ? e.g. suffering from a terminal illness or too unwell to be able to attend hospital clinic visits 11. Recent involvement in another research study (within 3 months)

Design outcomes

Primary

MeasureTime frame
To determine whether, in a pragmatic study that mirrors the realities of clinical decision-making, Laser-1st delivers a better HRQL at 3 years than does Medicine-1st in the management of patients with OAG and OHT.

Secondary

MeasureTime frame
To determine whether a Laser-1st treatment pathway: 1. Costs less than the conventional treatment pathway of Medicine-1st 2. Achieves the desired level of IOP with less intensive treatment over the course of the study 3. Leads to equivalent levels of visual function after 3 years 4. Is better tolerated by patients

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 3, 2026