A study to assess an automated laser device to treat glaucoma
| ISRCTN | ISRCTN14033075 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14033075 |
| ClinicalTrials.gov number | NCT03750201 |
| Secondary identifying numbers | GLAUrious-2017-01 |
- Submission date
- 22/03/2017
- Registration date
- 27/03/2017
- Last edited
- 13/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Glaucoma is an eye condition where the optic nerve, which connects the eye to the brain, becomes damaged over time. Many cases are caused by increased pressure in the eye (
intraocular pressure) due to a build-up of fluid. Glaucoma can result in blindness if left untreated and as such it is extremely important to diagnose and treat the condition. Usually, doctors treat the first symptoms of glaucoma by prescribing eye drops. Unfortunately, there can be side effects associated with the use of these eye drops and there are reports of non-compliance due to difficulties in inserting these drops, all of which can impact on how effective this treatment is. Selective Laser Trabeculoplasty (SLT) is a laser treatment that opens up the drainage tubes inside the eye, allowing more fluid to drain out of the eye, reducing the intraocular pressure and helping to control the progression of the disease. SLT is a technique routinely carried out by glaucoma specialists. It is conducted using a special type of lens (goniolens) that gently sits on the front surface of the eye. The procedure takes about 5 minutes. A new treatment called Direct Selective Laser Trabeculoplasty (DSLT) is performed directly, without there being any need to use a goniolens which sits on the eye. It is a shorter and simpler technique to perform compared to the standard SLT technique. In early studies, it has been shown to have similar pressure reducing abilities to the standard SLT technique. The aim of this study is to assess how well the new automated DSLT device developed by BELKIN Laser Ltd, Israel works in comparison with standard SLT, and determine whether it is as effective at reducing intraocular pressure.
Who can participate?
Patients aged over 40 with mild to moderate open angle glaucoma and ocular hypertension
What does the study involve?
The treating ophthalmologist performs a complete eye examination of each participant. This includes vision assessment, intraocular pressure and visual field measurements, examination of the back of the eyes and a check of the overall health of the eyes. On the eligibility visit, the intraocular pressure is checked and participants are randomly allocated to receive either SLT (the standard treatment) or DSLT (the new treatment). Intraocular pressure is measured after 1 day, 1 week, 1, 3, 6, and 12 months.
What are the possible benefits and risks of participating?
Benefits to taking part in this study include a 50% chance of receiving the new DSLT technique which could result in a speedier treatment, less inflammation and less discomfort during and following treatment. The risks of taking part in the study are the same as those associated with the standard laser procedure, including eye inflammation, discomfort and pressure spikes. Inflammatory reactions can affect either the front (more common) and/or back of the eye (retina – less common). The inflammation is usually mild to moderate and short-lived, usually reducing within 24 hours following treatment and gone within 5 days. Another risk associated with laser trabeculoplasty treatment is pressure spikes after the operation. These usually occur quite soon after the procedure (1-2 hours) and careful patient selection and preventative medication can be given to avoid their occurrence.
Where is the study run from?
1. Queen's University Belfast (UK)
2. The University of Genova (Italy)
3. Moorfields Eye Hospital NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
July 2017 to January 2023
Who is funding the study?
BELKIN Laser Ltd
Who is the main contact?
Dr Dorit Raz-Prag, dorit.razprag@alcon.com
Contact information
Public
BELKIN-Vision
13 Gan Raveh St.
Yavne
8122214
Israel
| Phone | +972 (54) 2560197 |
|---|---|
| dorit.razprag@alcon.com |
Scientific
4 Alonim St.
Givat Shmuel
5404402
Israel
 ORCID ID |
0000-0002-6174-1182 |
|---|
Scientific
Queen's University Belfast
Belfast
BT7 1NN
United Kingdom
| ORCID ID |
0000-0001-9866-3416 |
|---|
Study information
| Study design | Randomized controlled masked (investigator(s)) study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Direct selective laser trabeculoplasty (DSLT) in open angle glaucoma (OAG): a randomized controlled trial |
| Study acronym | GLAUrious |
| Study objectives | Direct Selective Laser Trabeculoplasty (DSLT) is not inferior to Selective Laser Trabeculoplasty (SLT) in reducing intraocular pressure (IOP). |
| Ethics approval(s) | 1. North West - Greater Manchester West Research Ethics Committee, ref: 17/NW/0358. 2. Regional Ethics Committee- Comitato Etico Regionale della Liguria, IRCCS San Martino, 27/07/2017, ref: 287REG2017 |
| Health condition(s) or problem(s) studied | Glaucoma |
| Intervention | Interventions as of 16/11/2018: Eligible patients who sign the informed consent will be enrolled at each of the study sites, and undergo a washout (in the case of being medicated). After washout there will be a baseline visit, where continued eligibility is confirmed. Following confirmation of continued eligibility, 50% of patients are randomized to each treatment group (DSLT or SLT). Randomization will be to a pre-determined randomization list. The un-masked investigator(s) will open the envelope corresponding to the subject ID and administer the treatment as indicated by the randomization envelope. Only one eye per participant will be included in the study and they will be treated using either DSLT or SLT as per the randomized treatment allocation. The ophthalmologist(s) who perform the follow up (1 day, 1 week, 1, 3, 6, and 12 months) will be masked as to the nature of the treatment the patient underwent. Previous interventions: Eligible patients who sign the informed consent will be enrolled at each of the study sites, and undergo a washout (in the case of being medicated). After washout there will be a baseline visit, where continued eligibility is confirmed. Following confirmation of continued eligibility, 50% of patients are randomized to each treatment group (DSLT or SLT). Randomization will be to a pre-determined randomization list. The un-masked investigator(s) will open the envelope corresponding to the subject ID and administer the treatment as indicated by the randomization envelope. Only one eye per participant will be included in the study and they will be treated using either DSLT or SLT as per the randomized treatment allocation. The ophthalmologist(s) who perform the follow up (3, 6, and 12 months) will be masked as to the nature of the treatment the patient underwent. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Primary effectiveness endpoint: The primary effectiveness endpoint is the difference between the two treatment groups between the mean (washed out for medicated patients) baseline IOP and the mean (washed out for medicated patients) IOP measured at 6 months. Eligible patients on medications will be washed out at both treatment groups. The mean intraocular pressure (IOP) at baseline before the treatment and washed out IOP at 6 months will be measured by Goldmann Applanation Tonometry. The difference between the two treatment groups in change between mean washout baseline and 6-month IOP will be estimated. Safety endpoints: Adverse events |
| Secondary outcome measures | 1. Mean percentage reduction in IOP, measured by Goldmann Applanation Tonometry at 3, 6, and 12 months 2. Number of medications being taken for each eye at baseline (before treatment) and 12 months |
| Overall study start date | 01/07/2017 |
| Completion date | 30/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Sex | Both |
| Target number of participants | 124 |
| Total final enrolment | 276 |
| Key inclusion criteria | 1. Age 40 years or older, with visual acuity > 6/60 in both eyes 2. Primary open-angle glaucoma including exfoliative or pigmentary glaucoma; added 03/06/2020: or ocular hypertension 3. IOP ≥ 22mmHg to ≤35mmHg (in the case of a medicated patient at the baseline visit following washout and in the case of a naïve (newly diagnosed) patient at the time of screening) 4. Gonioscopically visible scleral spur for 360 degrees without indentation 5. Ability to visualize the peri-limbal sclera for 360 degrees (using a speculum) 6. Willing and able to participate in the 12-month study, to comply with the study procedures and to adhere to the follow-up schedule 7. Participant capable of giving informed consent |
| Key exclusion criteria | Individuals with the following characteristics will be excluded from the study (unless specified otherwise, all ocular criteria refer to the study eye only): 1. Contraindications to conventional laser trabeculoplasty (e.g. corneal abnormalities, etc) 2. Angle Closure Glaucoma 3. Congenital or developmental glaucoma 4. Secondary glaucoma except exfoliative or pigmentary glaucoma 5. Presence of any Peripheral Anterior Synechiae (PAS) in the study eye 6. Inability to conduct a reliable visual field (defined as fixation losses, false positives or false negatives greater than 33%) 7. Any of the following visual field findings using the Humphrey visual field analyzer the SITA-standard 24-2 program: 7.1. A visual field MD of less than -12dB 7.2. Greater than or equal to 75% of points depressed below the 5% level and greater than or equal to 50% of points depressed below the 1% level on the PD plot 7.3. At least 50% of points (i.e., 2 or more) within the central 5 degrees with a sensitivity ≤0dB on the decibel plot 7.4. Points within the central 5 degrees of fixation with a sensitivity <15 dB in both hemifields on the decibel plot 8. A visual field MD of less than -12dB in the fellow eye 9. Cup:Disc Ratio of more than 0.8 10. More than two hypotensive mediations required 11. Prior incisional or laser glaucoma surgery 12. Prior corneal refractive surgery 13. Complicated cataract surgery ≤ 6 months prior to enrollment 14. Presence of visually significant cataract in the opinion of the investigator 15. Clinically significant disease in either eye as determined by the Investigator 16. Clinically significant amblyopia in either eye 17. Women who are pregnant or may become pregnant during the course of the study 18. Added 16/03/2018: Dense pigmentation or haemorrhage in the peri-limbal conjunctiva or anterior sclera 19. In the opinion of the investigator the participant might require other ocular surgery within the 12-month follow-up period, unless for further reduction of their IOP 20. Concurrent treatment with topical, nasal, inhaled or systemic steroids 21. Uncontrolled systemic disease that could impact the ability of the participant to attend follow up visits as per the discretion of the investigator |
| Date of first enrolment | 24/10/2018 |
| Date of final enrolment | 24/09/2021 |
Locations
Countries of recruitment
- England
- Israel
- Italy
- Northern Ireland
- United Kingdom
Study participating centres
BT7 1NN
United Kingdom
16132
Italy
London
EC1V 2PD
United Kingdom
Petah Tikva
49100
Israel
Haifa
3109601
Israel
Sponsor information
Industry
Gan Raveh 13
Yavne
8122214
Israel
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- EU Framework Programme for Research and Innovation H2020, Horizon 2020, Rahmenprogramm Horizont 2020, Programa Marco Horizonte 2020, Programme-cadre Horizon 2020, Programma quadro Orizzonte 2020, Program ramowy Horyzont 2020, Horizont 2020, Horizonte 2020, Orizzonte 2020, Horyzont 2020, Horizon 2020 Framework Programme (H2020), H2020
Results and Publications
| Intention to publish date | 15/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | Current Individual participant data (IPD) sharing plan as of 20/02/2024: There are not current plans to share the datasets. The device is CE marked Previous Individual participant data (IPD) sharing plan: The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Nathan Congdon |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 25/08/2021 | 27/08/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/01/2025: Contact details updated.
10/01/2025: The intention to publish date was changed from 31/12/2024 to 15/02/2025.
20/02/2024: The participant level data sharing statement was changed.
28/09/2023: The intention to publish date was changed from 30/09/2023 to 31/12/2024.
22/09/2023: Internal review.
20/09/2023: The public contact was replaced and the plain English summary was updated to reflect that change.
12/04/2023: Total final enrolment added, the intention to publish date was changed from 30/04/2023 to 30/09/2023.
17/01/2023: The contact confirmed the record is up to date.
13/12/2022: The following changes were made to the trial record:
1. The overall end date was changed from 15/12/2022 to 30/01/2023.
2. The intention to publish date was changed from 30/03/2023 to 30/04/2023.
3. The plain English summary was updated to reflect these changes.
17/10/2022: The following changes were made to the trial record:
1. The overall end date was changed from 28/09/2022 to 15/12/2022.
2. The intention to publish date was changed from 01/12/2022 to 30/03/2023.
3. The plain English summary was updated to reflect these changes.
27/08/2021: Publication reference added.
06/08/2020: The public contact was changed.
10/07/2020: The following changes were made to the trial record:
1. The recruitment resumed.
2. The trial participating centres Rabin Medical Center and Rambam Medical Center, Israel was added.
12/06/2020: The public contact details have been made visible.
04/06/2020: The intention to publish date was changed from 01/12/2021 to 01/12/2022.
03/06/2020: The following changes were made to the trial record:
1. The overall trial end date was changed from 28/05/2021 to 28/09/2022.
2. The inclusion criteria and plain English summary were updated.
3. The recruitment end date was changed from 24/05/2020 to 24/09/2021.
23/04/2020: Due to current public health guidance, recruitment for this study has been paused at all UK sites.
29/08/2019: The following changes were made:
1. The recruitment end date was updated from 24/08/2019 to 24/05/2020.
2. The overall trial end date was updated from 02/02/2020 to 28/05/2021.
3. The plain English summary was updated.
4. The ClinicalTrials'gov number was added.
5. The trial participating centre was added.
6. The sponsor details were updated.
7. The intention to publish date was updated from 01/06/2020 to 01/12/2021.
16/11/2018: The following changes were made:
1. The recruitment start date was changed from 01/04/2018 to 24/10/2018.
2. The recruitment end date was changed from 01/01/2019 to 24/8/2019.
3. The plain English summary was updated.
4. The interventions were updated.
5. The target number of participants was updated from 96 to 124.
6. The total target enrolment was updated from 96 to 124.
16/03/2018: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/08/2017 to 01/04/2018.
2. The recruitment end date was changed from 01/02/2018 to 01/01/2019.
3. The overall trial end date was changed from 02/02/2019 to 02/02/2020.
4. The intention to publish date was changed from 01/03/2019 to 01/06/2020.
5. The exclusion criteria were updated.
06/11/2017: Ethics approval has been updated.
31/08/2017: Ethics information added.
