A study aiming at showing the performance and safety of the Eagle device by collecting data from patients being treated for glaucoma or eye hypertension with the Eagle device
| ISRCTN | ISRCTN16769682 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16769682 |
| IRAS number | 337141 |
| Secondary identifying numbers | IRAS 337141, CPMS 60903 |
- Submission date
- 28/03/2024
- Registration date
- 02/07/2024
- Last edited
- 02/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
This study is designed to evaluate the performance and safety of the Eagle® device when used within the intended use covered by the CE marking and following the Standard of Care. The Eagle device is a laser device for direct selective laser trabeculoplasty (DSLT) for the treatment of glaucoma. The laser treatment with the Eagle device is performed without the need to use a lens that touches the eye as in the traditional laser treatment. An image processing algorithm automatically localises the target area, which the operator or eye care professional (ECP) readjusts if necessary. Once the operator has confirmed the target area, an eye-tracking system enables the eye movement to be tracked so that the laser pulses are delivered precisely to the target area.
Who can participate?
Patients aged 18 years old and over who underwent treatment with the eagle device for treatment of open-angle glaucoma including exfoliative or pigmentary glaucoma or ocular hypertension as per the approved indication with expected post-operative follow-up data of at least six months
What does the study involve?
This study is a registry designed to evaluate the performance and safety of the Eagle® device when used within the intended use covered by the CE marking and following the Standard of Care. The study will register the information usually collected by your doctor at the time points specified by them. The only requirement is that two doctor visits be recorded so the performance and safety of the treatment with the Eagle device can be evaluated.
What are the possible benefits and risks of participating?
Participants are unlikely to derive any personal health benefits from participating in this study because the collection of data for the registry is independent of the standard of care decisions made by their doctor. However, the results of the study may help to better assess the treatment of glaucoma in the future.
As only data are collected in the study, participation is not associated with any medical risks beyond the ones related to your medical care as decided and performed by the doctor.
Where is the study run from?
BELKIN Vision Ltd.
When is the study starting and how long is it expected to run for?
August 2023 to December 2025
Who is funding the study?
BELKIN Vision Ltd.
Who is the main contact?
BELKIN Vision: registry@belkin-vision.com
Medevise Consulting: clinicals@medevise-consulting.com
Contact information
Public, Scientific
BELKIN Vision
13 Gan Raveh Blvd.
Yavne
8122214
Israel
| Phone | +41 (0) 79 531 5257 |
|---|---|
| registry@belkin-vision.com |
Study information
| Study design | Observational |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital, Medical and other records, Other therapist office |
| Study type | Safety, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | An observational, registry-based study of performance and safety data from participants treated for open angle glaucoma or ocular hypertension with the Eagle device |
| Study acronym | BELKIN-PMCF |
| Study objectives | To assess the mean change from baseline in intraocular pressure (IOP) within the 4-8 months post-treatment interval following the direct selective laser trabeculoplasty treatment. |
| Ethics approval(s) |
1. Submitted 07/03/2023, West Midlands – Edgbaston (2 Redman Place, Stratford, E20 1JQ, United Kingdom; +44 (0)207 104 8155, (0)207 104 8357; edgbaston.rec@hra.nhs.uk), ref: None provided 2. Approved 27/02/2024, Ethik-Kommission Westfalen-Lippe (Gartenstraße 210–214, Münster, 48147, Germany; +49 (0)251 929-2460; ethik-kommission@aekwl.de), ref: 2024-040-f-S 3. Submitted 23/01/2024, Ethisch Comité UZA/UAntwerpen (Drie Eikenstraat 655, Edegem, 2650, Belgium; +32 (0)3 821 38 97; ethisch.comite@uza.be), ref: 6219 |
| Health condition(s) or problem(s) studied | Glaucoma and ocular hypertension |
| Intervention | The purpose of this registry is to evaluate the effectiveness and safety of the Eagle device when used within its designated use as outlined by the CE-marking and in adherence to standard care protocols. The information gathered will aid in the proactive monitoring of device performance and safety, aligning with the post-market surveillance requirements outlined in Regulation (EU) 2017/745. Initially, participants will undergo direct selective laser trabeculoplasty (DSLT) using the Eagle device to manage the elevated eye pressure associated with their glaucoma. This study seeks to analyze the average change in intraocular pressure (IOP) from baseline for 4-8 months post-treatment. The primary outcome assesses changes in IOP over time and the secondary outcomes will investigate the performance and safety of Eagle device in adult participants treated for open-angle glaucoma or ocular hypertension. This is an observational study and the data collection plan is not compulsory but offers a template for data collection depending on the standard of care in force at the site. The registry data will be collected at the three predefined post-treatment intervals of 0-4 months, 4-8 months and 8-12 months. When multiple visits occur within a single registry interval, then the latest available assessment taken within the interval is the one collected as part of the registry. Participants may not have data at all 3 post-treatment intervals. The following key data points are to be collected for both eyes, if performed by the investigators as part of the standard of care and where applicable the case report form will collect the information on right, left or both eyes, where applicable: Data collection before DSLT performed with the Eagle device: - Participant demographics (age and gender) - Ethnic group of the participant - Type of glaucoma - Angle pigmentation - Number and names of ocular medications at 1st treatment - Previous procedures Data collection on the day of standard of care DSLT performed with the Eagle device: - Date of procedure, baseline IOP, baseline BCDVA, baseline refraction - Treatment area (180° or 360◦) - Laser energy used for treatment on each participant’s eye - Physician’s assessment on the usability - Participant satisfaction after treatment Data collection after DSLT performed with the Eagle device: - IOP at each follow-up interval - Refraction at each follow-up interval (Optional) - Post-treatment surgical intervention - BCDVA at each follow-up interval - Name of ocular medications, if any, at follow-up intervals - Rates of Adverse Device Effects |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Eagle® |
| Primary outcome measure | Intraocular pressure (IOP) measured using data collected in medical records at the standard of care timepoint within the 4-8 months post-treatment interval following the direct selective laser trabeculoplasty treatment |
| Secondary outcome measures | 1. Performance of the device measured using data collected in patient medical records associated with the evaluation of IOP, potential post-treatment surgical intervention, retreatments with the Eagle device and ocular medication of the participant after treatment at the study end 2. Device safety measured using data collected in patient medical records associated with the rate of adverse device effects and device deficiencies at the study end 3. The usability for the practician measured using a bespoke questionnaire at the direct selective laser trabeculoplasty (DSLT) procedure visit 4. Patient experience measured using a bespoke questionnaire at the DSLT procedure visit |
| Overall study start date | 01/08/2023 |
| Completion date | 01/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 550 |
| Key inclusion criteria | 1. Adult participants who underwent treatment with the Eagle device for treatment of Open Angle Glaucoma including exfoliative or pigmentary glaucoma or ocular hypertension as per the approved indication. 2. Participants with expected post-operative follow-up data of at least six (6) months |
| Key exclusion criteria | Records of participants with any of the following conditions at the date of the treatment with the Eagle device, will not be included in the data collection: 1. Participants who are unable to fixate their head and/or eyes, such as participants suffering from nystagmus, tremors or similar conditions. 2. Participants with congenital glaucoma or active anterior segment inflammations. 3. Participants with any condition that obscures the limbus, such as melanosis affecting the limbus, severe arcus senilis affecting the limbus, pterygium affecting the limbus or any other such conditions. 4. Participants with any condition that causes poor visualization of the limbus that prevents the Eagle device’s treatment target identification. |
| Date of first enrolment | 01/05/2024 |
| Date of final enrolment | 01/05/2025 |
Locations
Countries of recruitment
- Belgium
- England
- Germany
- Israel
- Italy
- Scotland
- United Kingdom
Study participating centres
Inversness
IV2 5NA
United Kingdom
London
EC1V 2PD
United Kingdom
Jerusalem
9103102
Israel
Rome RM
00199
Italy
Caserta CE
81100
Italy
Wilrijk
2610
Belgium
Bochum
44892
Germany
Sponsor information
Industry
13 Gan Raveh Blvd.
Yavne
8122214
Israel
| Phone | +972-50-5744116 |
|---|---|
| marcia@belkin-vision.com | |
| Website | https://belkin-vision.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/04/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The results of the study will primarily serve as documentation for regulatory procedures and for internal decision making for future studies on comparative effectiveness. Communication plans also include publication, presentation in scientific congresses and inclusion in company materials. |
| IPD sharing plan | All personal registry subject data collected and processed for this registry will be maintained with adequate precautions to ensure the confidentiality of the data according to local, state, and federal laws and regulations. Data is pseudonymized and extracted, analysed, validated and reported in aggregate to prevent any potential that any investigator will access individual participant data in which the participant may be identified during data compilation, data reporting or data analysis. A report of the results of this registry may be published or sent to the appropriate health authorities in any country in which the registry device may be marketed, but the subject’s identity will not be disclosed in these documents. The online registry must be kept up-to-date so that it always reflects the latest observations on the participants enrolled in the clinical investigation. The online software OpenClinica and OpenClinica Insight will be used as the data registry. Data can be entered online, directly on the registry by the practician, after an independently planned interval following treatment with the Eagle device. The handling of all data on the Case Report Forms/registry questionnaires will be the responsibility of BELKIN Vision or their delegated representative. |
Editorial Notes
02/08/2024: Sponsor details updated and CPMS number added.
11/04/2024: Study's existence confirmed by Ethics Commission Westphalia-Lippe.
