None listed
Conditions
Brief summary
Glaucoma is the leading cause of irreversible blindness worldwide. The SINERGGI study will determine if early laser treatment in high-risk individuals can prevent glaucoma blindness.
Interventions
Selective laser trabeculoplasty (SLT) will be delivered using a Tango SLT device (Ellex). Topical anaesthetic drops will be administered prior to treatment, with SLT administered in a single sitting by an experienced consultant ophthalmologist using a laser gonioscopy lens to 360° of the trabecular meshwork through 100 non-overlapping laser shots (25 per quadrant), with laser energy varying from 0·3 to 1·4 mJ, using a clinical endpoint of fine bubble formation at the trabecular meshwork at leas
Selective laser trabeculoplasty (SLT) will be delivered using a Tango SLT device (Ellex). Topical anaesthetic drops will be administered prior to treatment, with SLT administered in a single sitting by an experienced consultant ophthalmologist using a laser gonioscopy lens to 360° of the trabecular meshwork through 100 non-overlapping laser shots (25 per quadrant), with laser energy varying from 0·3 to 1·4 mJ, using a clinical endpoint of fine bubble formation at the trabecular meshwork at least 50% of the time. The duration of the procedure is approximately 5 minutes per eye.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Ability to understand and sign a written informed consent form prior to initiation of study. 2. Males and females aged > 18 years. 3. Treatment naive glaucoma suspects or ocular hypertension (IOP>21, but =28 mmHg) - Participants who had previously received topical glaucoma medication can undergo a washout period of 6 weeks or more before reviewing their eligibility 4. Top tertile (high risk) of the PROGRESSA Risk Predictor Algorithm 5. Open drainage angles on gonioscopy. 6. May include pseudoexfoliation syndrome.
Exclusion criteria
1. BCVA < 6/18 (enrolled eye). 2. Glaucoma (reproducible field loss), current IOP lowering medication, earlier SLT in study eye. 3. Active treatment for another ophthalmic condition, or participation in another interventional trial 4. Retinal, optic nerve, or neurological disease causing a visual field defect. 5. Pigment dispersion syndrome or anterior segment dysgenesis. 6. Significant cognitive impairment or inability to perform a reliable automated perimetry. 7. Contraindications to SLT (active uveitis, insufficient view of trabecular meshwork due to narrow drainage angles or PAS). 8. Symptomatic cataract.
Outcome results
None listed