Ocular Hypertension Clinical Trial
— OSLT-ROfficial title:
Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial
Verified date | August 2023 |
Source | Vastra Gotaland Region |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Ophthalmology, Skaraborg Hospital | Skövde | Vastra Gotaland |
Sweden | Department of Ophthalmology, NU Hospital Group | Uddevalla | Vastra Gotaland |
Lead Sponsor | Collaborator |
---|---|
Vastra Gotaland Region | Göteborg University |
Sweden,
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. |
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