Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial (OSLT-R)

Vastra Gotaland Region

Status: Invitation-only

Conditions: Ocular Hypertension; Glaucoma, Open-Angle; Pseudoexfoliation Glaucoma

Treatments: Procedure: SLT

Study type: Interventional

Funder types: Other

Identifiers

NCT05159960

OSLT-R

277612 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 4 patient groups

180/low

Experimental group

Description:

SLT treatment in either half of the trabecular meshwork (180 degrees) consisting of 50+/-5 adjacent laser effects. The energy is adjusted 0,1 mJ below the threshold of formation of micro bubbles.

Treatment:

Procedure: SLT

180/high

Experimental group

Description:

SLT treatment in either half of the trabecular meshwork (180 degrees) consisting of 50+/-5 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects.

Treatment:

Procedure: SLT

360/low

Experimental group

Description:

SLT treatment in the full circumference of the trabecular meshwork (360 degrees) consisting of 100+/-10 adjacent laser effects. The energy is adjusted 0,1 mJ below the threshold of formation of micro bubbles.

Treatment:

Procedure: SLT

360/high

Experimental group

Description:

SLT treatment in the full circumference of the trabecular meshwork (360 degrees) consisting of 100+/-10 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects.

Treatment:

Procedure: SLT