Clinical trial NCT05159960: Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial
Official title: Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Glaucoma, Open-Angle
Pseudoexfoliation Glaucoma
Ocular Hypertension
Keywords: Selective Laser Trabeculoplasty
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Göteborg University
First posted: 2021-12-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Relative IOP reduction for each SLT iteration
timeFrame: 1-6 months after each SLT, as described above
Secondary outcomes:
measure: Survival (for each SLT iteration)
timeFrame: 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.
measure: Survival (repeat SLT allowed)
timeFrame: 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.
measure: Achievement of 20% reduction in IOP
timeFrame: 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.
measure: Absolute IOP reduction for each SLT iteration
timeFrame: 1-6 months after each SLT, as described above
measure: Pain perioperatively: on a scale
timeFrame: Immediately after treatment
measure: Pain postoperatively: on a scale
timeFrame: During the first month
measure: Light sensitivity postoperatively: on a scale
timeFrame: During the first month
measure: Impairment of vision postoperatively: on a scale
timeFrame: During the first month
measure: Redness postoperatively: on a scale
timeFrame: During the first month
measure: Adverse events
timeFrame: 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.
Other outcomes:
Locations:
city: Skövde
country: Sweden
facility: Department of Ophthalmology, Skaraborg Hospital
state: Vastra Gotaland
city: Uddevalla
country: Sweden
facility: Department of Ophthalmology, NU Hospital Group
state: Vastra Gotaland
Study officials:
affiliation: Vastra Gotaland Region
name: Tobias Dahlgren, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vastra Gotaland Region
name: Marcelo Ayala, MD, PhD
role: STUDY_CHAIR
References: