None listed
Conditions
Brief summary
The primary aims of this study are to determine the effectiveness of selective laser trabeculoplasty (SLT) with topical medication therapy in the treatment of early Glaucoma with regards to Quality of Life and Cost-effectiveness. The study also aims to determine factors associated with the outcomes of these two therapies, such as pre-treatment IOP and compare the safety and efficacy of the two therapies. Two groups of patients will be recruited for the study: 1) patients with a diagnosis of Primary Open Angle Glaucoma who have not previously received treatment for this and; 2) patients with a diagnosis of Pseudo-exfoliative Glaucoma who have not previously received treatment. Patients will be asked to undergo a Quality of Life Questionnaire Interview over the telephone and will be asked to provide information on the costs related to their health care, treatment of their glaucoma and attendance at appointments. They will also be clinically examined where information including their intraocular pressures, visual fields, optic discs and visual acuity will be recorded. They will also be asked to provide information relating to their ethnicity, level of education, date of birth, employment status and medical history. Participants will be randomized to either receive Selective laser Trabeculoplasty or Topical eye drops at the Baseline visit. They will then be seen every 6 months for 2 years. If in the first 6 months, however, they do not achieve a 25% reduction in Intraocular Pressure from baseline levels, they will be seen 6 weekly until this is achieved. Analysis of the data will be on an intention to treat basis where participant outcomes will be analysed according to the group they were randomised rather than the actual treatment they received. The types of analysis to be performed includes Rasch analysis of the Quality of Life questionnaire responses, Cost Effectiveness analysis, multivariable regression models and generalised estimating equations. This study addresses novel outcomes that have previously not been addressed before, including taking into account the patients perspective by examining the impact of the two types of treatment on patients quality of life and also the cost of the two treatments, both to the patient and to society.
Interventions
Selective Laser Trabeculoplasty(SLT): this procedure will use frequency doubled, 1-switched Nd:Yag lasers emitting at 532nm with a pulse duration of 3ns, spot size of 400um and pulse energies ranging from 0.2-1.7mJ, coupled to a slit delivery system with a helium-neon laser (HeNe) aiming system and any mirrored gonio lens that doesn't magnify for all patients randomised to SLT treatment. The laser will be focused on the trabecular meshwork using the HeNe aiming beams and a single laser pulse
Selective Laser Trabeculoplasty(SLT): this procedure will use frequency doubled, 1-switched Nd:Yag lasers emitting at 532nm with a pulse duration of 3ns, spot size of 400um and pulse energies ranging from 0.2-1.7mJ, coupled to a slit delivery system with a helium-neon laser (HeNe) aiming system and any mirrored gonio lens that doesn't magnify for all patients randomised to SLT treatment. The laser will be focused on the trabecular meshwork using the HeNe aiming beams and a single laser pulse will be delivered at the 3 o'clockposition. The laser energy will be increased or reduced by 0.1mJ increments until fine 'champagne' bubbles are generated. Initial 180 degrees treatments of approximately 50 applicaiton will be applied. There can be up to 3 SLT treatments administered during the trial depending on the IOP response to treatment. Each procedure will take approximately 30-40 minutes.
Sponsors
Centre for Eye Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age - minimum 35 years; Newly diagnosed, previously untreated patients with either primary open angle glaucoma or pseudo-exfoliation glaucoma that, in the investigators opinion, warrants treatment; IOP greater or equal to 18mmHg but less than 40mmHg in at least one eye on 2 consecutive visits; Visual Field – mean deviation (MD) values less than -12 dB at baseline; Written informed consent has been obtained.
Exclusion criteria
History or evidence of glaucoma other than primary open angle glaucoma, or pseudo-exfoliation glaucoma; Advanced glaucomatous field loss with MD > -12dB; History of topical or systemic ocular antihypertensive medication usage; Previous intraocular surgery (including glaucoma laser or glaucoma surgery), with the exception of uncomplicated phacoemulsification; Iridotrabecular drainage angle anomalies; Evidence of moderate non-proliferative diabetic retinopathy or worse, neovascularization or rubeosis iridis; Current use of a systemic corticosteroid, epinephrine or clonidine; Patients, who in the opinion of the investigator, will not respond adequately to treatment or who may require glaucoma surgery within the two years of study follow up; Patients who are pregnant or currently breastfeeding; Patient, who has a condition or is in a situation that in the investigator’s opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient’s participation in the study.
Outcome results
None listed