Clinical trial NCT03798223: Optimal Treatment Protocol for Selective Laser Trabeculoplasty
Official title: Optimal Treatment Protocol for Selective Laser Trabeculoplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
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: 2019-01-09
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: A randomized controlled trial to evaluate which treatment protocol in selective laser trabeculoplasty that is most optimal in terms of efficacy and safety.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in intraocular pressure (IOP)
timeFrame: Before SLT and thereafter regularly for 3 years
measure: Achievement of 20% reduction in IOP
timeFrame: For 3 years
measure: Survival (no additional intervention)
timeFrame: For 3 years
Secondary outcomes:
measure: Survival (SLT allowed)
timeFrame: For 3 years
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
timeFrame: During the first month
measure: Impairment of vision postoperatively
timeFrame: During the first month
measure: Redness postoperatively
timeFrame: During the first month
measure: Flare (inflammation measurement of the anterior chamber)
timeFrame: Pre-operatively and then one day, one week and one month post-operatively.
measure: Adverse events
timeFrame: 3 years (although adverse events, if any, are anticipated to emerge in the first post-operative days or weeks).
Other outcomes:
Locations:
city: Boras
country: Sweden
facility: Ogonkliniken, Sodra Alvsborgs Sjukhus
state: Vastra Gotaland
city: Molndal
country: Sweden
facility: Ogonkliniken, Sahlgrenska Universitetssjukhuset
state: Vastra Gotaland
city: Skovde
country: Sweden
facility: Ogonkliniken, Skaraborgs Sjukhus
state: Vastra Gotaland
city: Uddevalla
country: Sweden
facility: Ogonkliniken NU-sjukvarden
state: Vastra Gotaland
Study officials:
affiliation: Vastra Gotaland Region
name: Marcelo Ayala, MD, PhD
role: STUDY_CHAIR
affiliation: Vastra Gotaland Region
name: Tobias Dahlgren, MD
role: PRINCIPAL_INVESTIGATOR
References: