Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial

Ocular Hypertension Clinical Trial

— OSLT-R  

Official title:

Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05159960
• Other study ID #: OSLT-R
• Secondary ID: 277612
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: November 30, 2025

Study information

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

Clinical Trial 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.

Description:

Subjects already included in the OSLT trial (NCT03798223) will be invited to the extended trial (OSLT-R) 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. Each patient is followed until the last of: - 3 years after OSLT inclusion - 31 December 2024 or - Six months after the last SLT was performed, during the above time period. 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 the frequency and severity of 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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	Department of Ophthalmology, Skaraborg Hospital	Skövde	Vastra Gotaland
Sweden	Department of Ophthalmology, NU Hospital Group	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	Relative IOP reduction for each SLT iteration	Relative IOP reduction for each SLT iteration is calculated as the percentage IOP reduction from baseline (the mean of 3 pre-SLT measurements) to result IOP (the mean of the IOP at follow-up 1, 3 and 6 months after SLT).	1-6 months after each SLT, as described above
Secondary	Survival (for each SLT iteration)	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, including repeat SLT.	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.
Secondary	Survival (repeat SLT allowed)	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, except repeat SLT.	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.
Secondary	Achievement of 20% reduction in IOP	The proportion of eyes achieving and maintaining an IOP reduction of at least 20% compared to baseline.	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.
Secondary	Absolute IOP reduction for each SLT iteration	Absolute IOP reduction for each SLT iteration is calculated as the IOP reduction, in mmHg, from baseline (the mean of 3 pre-SLT measurements) to result IOP (the mean of the IOP at follow-up 1, 3 and 6 months after SLT).	1-6 months after each SLT, as described above
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: on a scale	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: on a scale	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: on a scale	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	Adverse events	The type and frequency of adverse events will be recorded and analyzed in each of the study arms.	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.