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Clinical Trials/ISRCTN32038223
ISRCTN32038223
Completed
未知

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.

Moorfields Eye Hospital (UK)0 sites718 target enrollmentJuly 23, 2012

Overview

Phase
未知
Intervention
Not specified
Conditions
Glaucoma
Sponsor
Moorfields Eye Hospital (UK)
Enrollment
718
Status
Completed
Last Updated
3 years ago

Overview

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)

Registry
who.int
Start Date
July 23, 2012
End Date
October 1, 2020
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Moorfields Eye Hospital (UK)

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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