open angle glaucoma and ocular hypertension
Conditions
Interventions
experimental group:Selective Laser Trabeculoplasty
Sponsors
Zhongshan Ophthalmic Center,Sun Yat-sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We have used the NICE recommended thresholds for initiating treatment1, with stringent diagnostic definitions of disease (OAG or OHT) for entry into the study. Uniocular patients are eligible. Participants are required to have either OAG or OHT newly requiring treatment and: 1. A decision to treat has been made by a Consultant Glaucoma Specialist; 2. Age over 18 years and able to provide informed consent; 3. Able to complete uality of life, disease-specific symptom and cost questionnaires in English (physical help with completion and assistance with reading will be permitted as long as an interpreter is not required); 4. An ability to perform a visual field test in the study eye(s) with less than 15% false positives.
Exclusion criteria
Exclusion criteria: 1. Advanced glaucoma in the potentially eligible eye as determined by EMGT criteria 77: visual field loss mean deviation worse than -12dB in the better or -15dB in the worse 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 lasermounted slit-lamp; past history of or active uveitis, neovascular glaucoma, inadequate visualisation of TM etc); 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. Congenital or early childhood glaucoma; 7. Visually significant cataract in symptomatic patients who want cataract surgery. Patients with lens opacity who are happy with their current acuity may be enrolled; 8. Under current,active treatment for another ophthalmic condition in the Hospital Eye Service. (This applies to both eyes, even if one is not in the trial, as the fellow eye might determine the patient's visit frequency); 9. Any history of retinal ischaemia, macular oedema or diabetic retinopathy; 10. Age-related macular degeneration with neovascularisation in either eye or geographic atrophy and VA worse than 6/36 in a study eye; 11. Visual acuity worse than 6/36 in a study eye. Non-progressive visual loss better than 6/36 due to any comorbidity is permitted provided that it does not affect response to treatment or later surgical choices and is not under active follow-up (e.g. an old, isolated retinal scar no longer under review, amblyopia); 12. Any previous intra-ocular surgery, except uncomplicated phaco -emulsification at least one year before. (This applies to both eyes, even if one is not in the trial, as it may affect the required treatment intensity for any glaucoma in the fellow eye); 13. Current pregnancy or intention to become pregnant within the duration of the trial. [Unanticipated pregnancy will lead to the normal limitation of the choice of medication available but not cause the participant to leave the trial until such as a time as a choice between surgery or SLT arises (when it would be unethical to withhold SLT and progress to surgery without anti-metabolites)]; 14. 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; 15. Recent involvement in another interventional research study (within 3 months).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health-Related Quality of Life; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment Pathway Cost and Cost-Effectiveness;Glaucoma-specific treatment-related quality of life: Glaucoma Utility Index (GUI);Patient Reported Disease and Treatment Related Symptoms: Glaucoma Symptom Scale (GSS);Patient Reported Visual Function: Glaucoma Quality of Life - 15 (GQL-15);Objective measures of pathway effectiveness and visual function;Objective measures of the safety profiles of each pathway;Concordance / Compliance; | — |
Countries
China
Contacts
Public ContactMinbin Yu, Gus Gazzard
Outcome results
None listed