Selective laser trabeculoplasty in high-risk glaucoma suspects: a randomized controlled trial.

Not Applicable

Recruiting

• Conditions: Glaucoma; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12621000324819
• Lead Sponsor: Flinders University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-23
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite primary outcome of development of a reproducible glaucomatous visual field defect, or a reproducible IOP > 28 mmHg, or a reduction in circumpapillary RNFL thickness of 10% from baseline in either the superior or inferior quadrant (hemifield RNFL loss)[ HVF and bIOP testing will be performed at baseline (pre-intervention), and 6/12/18/24/30/36 months post-intervention.]

Secondary Outcome Measures

Name	Time	Method
Rate of the pointwise total deviation change on 24-2 SITA Standard Humphrey Visual Field (HVF) testing.<br>[ HVF testing will be performed at baseline (pre-intervention), and 6/12/18/24/30/36 months post-intervention.];Rate of the global mean deviation change on 24-2 SITA Standard Humphrey Visual Field (HVF) testing.[ HVF testing will be performed at baseline (pre-intervention), and 6/12/18/24/30/36 months post-intervention.];Retinal nerve fibre layer loss in microns/year as measured by ocular coherence tomography (OCT).[ OCT testing will be performed at baseline (pre-intervention), and 6/12/18/24/30/36 months post-intervention.];Patient-reported outcome measures (PROMs) using the GlauCAT questionnaire.[ ];Patient-reported outcome measures (PROMs) using the GlauCAT questionnaire.[ Patient reported outcome measures obtained at visit 0 and at 1 and 36 months post intervention]