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

Ocular Hypertension Clinical Trial

Official title:
Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05159960
Study type Interventional
Source Vastra Gotaland Region
Contact
Status Enrolling by invitation
Phase N/A
Start date January 10, 2022
Completion date November 30, 2025
View Details
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