Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-31 @ 7:25 PM
Study NCT ID:
NCT05159960
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-30
First Post:
2021-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial
Sponsor:
Vastra Gotaland Region
Organization:
Study Overview
Official Title:
Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OSLT-R
Brief 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.
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.
Detailed Description:
Subjects already included in the OSLT trial (NCT03798223) will be invited to the extended trial (OSLT-R) at the time of SLT re-treatment or 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.
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 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.
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 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 277612 | OTHER | FoU i VGR ID number | View |