GLAUrious long-term follow-up study of glaucoma laser treatment
| ISRCTN | ISRCTN96782911 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96782911 |
| IRAS number | 329958 |
| Secondary identifying numbers | CA-PL-01-010, CPMS 57059, IRAS 329958 |
- Submission date
- 07/07/2023
- Registration date
- 23/07/2023
- Last edited
- 08/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English Summary
Background and study aims
This study will only enroll participants who took part in a study called GLAUrious, conducted between 2018 and 2021. The purpose of the original study was to assess the safety and effectiveness of a new automated direct selective laser trabeculoplasty device (DSLT).
Selective Laser Trabeculoplasty (SLT) is a laser-based procedure used to treat open-angle glaucoma. It involves using a low-energy laser to target and stimulate specific cells in the eye's drainage system, improving fluid outflow and reducing intraocular pressure. Unlike other laser treatments, SLT is "selective" and doesn't cause damage to surrounding tissue. By enhancing drainage, SLT helps manage glaucoma and prevent vision loss. It is a safe and effective alternative to medication or surgery, with minimal side effects.
Who can participate?
All participants who were part of the GLAUrious study
What does the study involve?
A one-off visit in which a few assessments, as part of your normal eye care will be conducted. This is so that we can look at the long-term safety with the treatment types looked at in the original study and let us see if there are any differences between them over the long term.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Belkin Vision (Israel)
When is the study starting and how long is it expected to run for?
July 2023 to August 2024
Who is funding the study?
Belkin Vision (Israel)
Who is the main contact?
glauriousltfu@belkin-vision.com
Contact information
Public
13 Gan Raveh St.
Yavne
8122214
Israel
| Phone | +972-8-8571619 |
|---|---|
| glauriousltfu@belkin-vision.com |
Study information
| Study design | Observational long-term follow-up |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Safety |
| Participant information sheet | Not available in web format; please use contact details to request a participant information sheet. Study is restricted to the former participants of the original GLAUrious clinical trial. |
| Scientific title | Long-term observational follow-up of participants treated in the GLAUrious trial |
| Study acronym | GLAUrious LTFU |
| Study hypothesis | Observational study to assess long term results |
| Ethics approval(s) |
Not yet submitted |
| Condition | Glaucoma |
| Intervention | Cross sectional, observational study examining participants enrolled to the GLAUrious study having received either SLT or DSLT treatment as part of the randomized controlled trial. Qualified participants will be contacted to ask if they would be willing to participate in an observational follow up study to collect data to assess the long-term safety of participants treated as part of this randomized controlled study. If they agree, they will be asked to attend the clinic for one visit. Participants are expected to be in the clinic for about 3-4 hours. The following clinical assessment will be performed for all study participants in both eyes in this order: • Medical History • Ocular history (including details of any secondary surgical intervention, previous contact lens wear and glaucoma medication administration) • Manifest refraction and BVCA • Visual field • Slit lamp examination • IOP • Fundus Examination (if BCVA warrants this assessment) |
| Intervention type | Other |
| Primary outcome measure | Safety parameters (slit lamp exam). This observational study includes only one single visit. |
| Secondary outcome measures | Additional safety parameters (IOP, visual field, and fundus exam). This observational study includes only one single visit. |
| Overall study start date | 07/07/2023 |
| Overall study end date | 01/08/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Sex | Both |
| Target number of participants | 192 |
| Participant inclusion criteria | Participants enrolled to the GLAUrious study and treated with either the SLT or DSLT between November 2018 and May 2021 |
| Participant exclusion criteria | Participants who were not enrolled to the GLAUrious study and treated with either the SLT or DSLT between November 2018 and May 2021 |
| Recruitment start date | 01/08/2023 |
| Recruitment end date | 30/09/2023 |
Locations
Countries of recruitment
- England
- Georgia
- Israel
- Italy
- Northern Ireland
- United Kingdom
Study participating centres
16132
Italy
BT9 7AB
United Kingdom
EC1V 2PD
United Kingdom
4941492
Israel
3109601
Israel
9103102
Israel
8457108
Israel
5822012
Israel
Georgia
Georgia
Georgia
91120
Israel
6789140
Israel
3436212
Israel
Sponsor information
Industry
13 Gan Raveh St.
Yavne
8122214
Israel
| Phone | +972-8-8571619 |
|---|---|
| glauriousltfu@belkin-vision.com | |
| Website | https://belkin-vision.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
08/08/2023: Internal review.
21/07/2023: Study's existence confirmed by the HRA.
