aser-1st vs Drops-1st for Glaucoma and Ocular Hypertensio

Not Applicable

Completed

• Conditions: Glaucoma; Eye Diseases

• Registration Number: ISRCTN32038223
• Lead Sponsor: Moorfields Eye Hospital (UK)

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28903966 protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28982956 pre-results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30862377 results 2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/31264958 NIHR report 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32005561 results (added 03/02/2020) 2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/31028768 clinical efficacy, predictors of success, and safety report (added 10/03/2020) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35534178/ Validation of the RCOphth and UKEGS glaucoma risk stratification tool 'GLAUC-STRAT-fast' (added 10/05/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36122660/ (added 20/09/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-23
• Study Completion: 2020-10-01
• Last Update Posted: 3 October 2022

Recruitment & Eligibility

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

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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