Optimal Treatment Protocol for Selective Laser Trabeculoplasty (OSLT)

Vastra Gotaland Region

Status: Active, not recruiting

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

Treatments: Procedure: SLT

Study type: Interventional

Funder types: Other

Identifiers

NCT03798223

254861 (Other Identifier)

Optimal SLT

Details and patient eligibility

About

A randomized controlled trial to evaluate which treatment protocol in selective laser trabeculoplasty that is most optimal in terms of efficacy and safety.

Full description

A randomized controlled trial in which individuals scheduled for SLT are randomized to one of four treatment protocols, which represent the most common variants of the treatment in clinical use.

Treatment is performed either at 360 degrees or 180 degrees and with a laser energy level either 0,1 millijoules (mJ) below the microbubble formation limit ("low" energy) or at a level that gives microbubbles at 50-75% of laser effects ("high" energy). This gives four treatment arms: 180/low, 180/high, 360/low and 360/high. Group allocation is masked for the patient and is coded in the records.

The results for short and long term treatment effects are compared between the groups, as well as the complication rate and postoperative discomfort.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis primary open-angle glaucoma, pseudo-exfoliative glaucoma or ocular hypertension.
• intra-ocular pressure (IOP) at least 18 mmHg treatment day.
• treatment is performed by an experienced laser surgeon.
• SLT treatment and follow-up are expected to be possible to perform in an adequate way, considering anatomical factors, age and the general health of the patient.

Exclusion criteria

• change of IOP-lowering medication during the last three months.
• planned change of intra-ocular-pressure-lowering medication.
• previous glaucoma surgery (other than SLT and ALT)
• previous intra-ocular surgery during the last three months.
• previous intra-ocular inflammatory disease during the last year.
• planned intra-ocular surgery.
• hyper-pigmented anterior chamber angle.

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 the lower 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 the lower 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