Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SLT.
- Who it may be relevant to
- Registry conditions: Glaucoma, Open-Angle, Pseudoexfoliation Glaucoma, Ocular Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Glaucoma is a common eye disease that can lead to blindness. The only known way to reduce the rate of disease progression is by reducing the pressure in the eye (the intraocular pressure, IOP). Selective laser trabeculoplasty (SLT) is an ophthalmic laser intervention with the purpose of reducing the IOP. SLT can be performed in different ways, with four of the treatment protocols being evaluated in the Optimal SLT (OSLT) trial. SLT is a repeatable procedure, but scientific evidence is scarce regarding more than one repetition. In this trial, patients included in the OSLT trial will be invited to the extended trial (OSLT-R), for further follow-up and re-treatment with SLT, if needed.
Detailed description
Subjects already included in the OSLT trial (NCT03798223) will be invited to the extended trial (OSLT-R) at the time of SLT re-treatment or when OSLT follow up is scheduled to terminate. Patients are re-treated as needed, according to the randomized group assignment performed in the OSLT inclusion process.
The OSLT-R trial is aiming to elucidate:
* If the SLT efficacy, in terms of relative IOP reduction (percent of baseline IOP), changes with additional SLT iterations. * If the longevity of IOP reduction after SLT changes with additional SLT iterations. * If repeated SLT is associated with a change in postoperative discomfort or adverse events.
All of the above will be analyzed within each of the four treatment groups (SLT protocols) in the trial. Further, analysis will also be conducted regarding differences between the treatment groups regarding the above.
Further, analysis will be performed regarding SLT efficacy depending of the total number of SLT:s an eye has received, including those performed before entering the OSLT and OSLT-R trials.
Interventions
- Procedure SLT
A drop of Pilocarpine 4% is administered to the eye 20 minutes before SLT. Immediately before SLT a drop of Tetracaine hydrochloride 1% is administered. Selective laser trabeculoplasty is conducted through a Latina lens, in a fashion determined by randomization to a study arm (see description).
Primary outcome measures
- Relative IOP reduction for each SLT iteration [Time frame: 1-6 months after each SLT, as described above]
Secondary outcome measures (10)
- Survival (for each SLT iteration) [Time frame: From randomization to failure (IOP lowering intervention, except repeat SLT) or censoring (death, patients choice), assessed until the last of: 1. 3 years after randomization; 2. 31 Dec 2024 or; 3. Six months after the last SLT during that timespan.]
- Survival (repeat SLT allowed) [Time frame: From each SLT iteration to failure (IOP lowering intervention incl. repeat SLT) or censoring (death, patients choice), assessed until the last of: 1. 3 years after randomization; 2. 31 Dec 2024 or; 3. Six months after the last SLT during that timespan.]
- Achievement of 20% reduction in IOP [Time frame: From randomization until the last of: 1. 3 years after randomization; 2. 31 Dec 2024 or; 3. Six months after the last SLT during that timespan.]
- Absolute IOP reduction for each SLT iteration [Time frame: 1-6 months after each SLT, as described above]
- Pain perioperatively: on a scale [Time frame: Immediately after treatment]
- Pain postoperatively: on a scale [Time frame: During the first month]
- Light sensitivity postoperatively: on a scale [Time frame: During the first month]
- Impairment of vision postoperatively: on a scale [Time frame: During the first month]
- Redness postoperatively: on a scale [Time frame: During the first month]
- Adverse events [Time frame: From randomization until the last of: 1. 3 years after randomization; 2. 31 Dec 2024 or; 3. Six months after the last SLT during that timespan. However, generally adverse events are anticipated to emerge in the first post-operative days or weeks.]
Eligibility criteria
Inclusion criteria
- Included in the OSLT trial
- Followed up without the need for other treatment escalation than repeat SLT
Exclusion criteria
- Unable to participate in follow up due to health conditions, strength or physical location.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Sweden · 2 centers
- Department of Ophthalmology, Skaraborg Hospital — Skövde
- Department of Ophthalmology, NU Hospital Group — Uddevalla
Identifiers
NCT: NCT05159960 · OSLT-R · 277612