An observational, registry-based study of performance and safety data from participants treated for open angle glaucoma or ocular hypertension with the Eagle device
Glaucoma and ocular hypertension
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 stand
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
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.