Optimal Treatment Protocol for Selective Laser Trabeculoplasty

Ocular Hypertension Clinical Trial

— OSLT  

Official title:

Optimal Treatment Protocol for Selective Laser Trabeculoplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03798223
• Other study ID #: Optimal SLT
• Secondary ID: 254861
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: May 31, 2025

Study information

• Verified date: January 2023
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Exfoliation Syndrome
• Glaucoma
• Glaucoma, Open-Angle
• Ocular Hypertension
• Pseudoexfoliation Glaucoma

Intervention

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).

Locations

Country	Name	City	State
Sweden	Ogonkliniken, Sodra Alvsborgs Sjukhus	Boras	Vastra Gotaland
Sweden	Ogonkliniken, Sahlgrenska Universitetssjukhuset	Molndal	Vastra Gotaland
Sweden	Ogonkliniken, Skaraborgs Sjukhus	Skovde	Vastra Gotaland
Sweden	Ogonkliniken NU-sjukvarden	Uddevalla	Vastra Gotaland

Sponsors (2)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intraocular pressure (IOP)	The IOP is measured with a Goldmann Applanation Tonometer (GAT) three times before SLT and then at regular intervals after the procedure. The reduction is registered and analyzed in absolute (mmHg) and relative (percent of the IOP before SLT) measures.; Measurement of IOP is planned 1, 3, 6 and 12 months post SLT, and thereafter every six months for 3 years after SLT. The study is conducted in a regular clinical setting and the above mentioned times might be delayed. If target pressure is not achieved, measurements will be planned at shorter intervals, according to a specified algorithm, due to safety reasons.	Before SLT and thereafter regularly for 3 years
Primary	Achievement of 20% reduction in IOP	See Outcome 1. Analysis of differences between the study arms will also be conducted measuring the proportion of eyes achieving 20% reduction in IOP or more at different time points in each group.	For 3 years
Primary	Survival (no additional intervention)	Kaplan-Meier survival analysis will be conducted, measuring the proportion of eyes that stay in the study groups but do not receive any further IOP-lowering intervention (medical, surgical or laser).	For 3 years
Secondary	Survival (SLT allowed)	See Outcome 3. Kaplan-Meier survival analysis is performed the same way, but additional SLT-treatment will not be judged as failure.	For 3 years
Secondary	Pain perioperatively: on a scale	The patient will grade perioperative pain on an arbitrary scale between 0 (no pain) and 4 (maximum pain) on a written protocol.	Immediately after treatment
Secondary	Pain postoperatively: on a scale	The patient will grade post-operative pain on an arbitrary scale between 0 (no pain) and 4 (maximum pain) on a written protocol, also stating the duration of pain.	During the first month
Secondary	Light sensitivity postoperatively	The patient will grade post-operative sensitivity to light on an arbitrary scale between 0 (no difference) and 4 (very intense sensitivity to light) on a written protocol, also stating the duration of light sensitivity.	During the first month
Secondary	Impairment of vision postoperatively	The patient will grade post-operative impairment of vision on an arbitrary scale between 0 (no difference) and 4 (cannot see ones own hand) on a written protocol, also stating the duration of vision impairment.	During the first month
Secondary	Redness postoperatively	The patient will grade post-operative redness of the eye on an arbitrary scale between 0 (no difference) and 4 (very intense redness) on a written protocol, also stating the duration of redness.	During the first month
Secondary	Flare (inflammation measurement of the anterior chamber)	15 participants from each treatment arm (60 in total, randomized in a separate block after informed consent) will undergo measurement with a Laser Flare Meter.	Pre-operatively and then one day, one week and one month post-operatively.
Secondary	Adverse events	The type and frequency of adverse events will be recorded and analyzed in each of the study arms.	3 years (although adverse events, if any, are anticipated to emerge in the first post-operative days or weeks).