Meta description: Regulatory news highlights a new combined phacoemulsification and goniotomy trial exploring device performance and safety in open angle glaucoma patients worldwide.
This article, dated February 19, 2026, provides a regulatory oriented update on a trial testing a goniotomy procedure during cataract surgery. The sponsor is Henry Ford Health System. The trial status is not yet recruiting and is listed on ClinicalTrials.gov under NCT07418853. The intervention is described as Goniotomy performed in the context of a combined phacoemulsification procedure. The scope includes open angle glaucoma conditions such as POAG and related secondary forms. The clinical context reflects an early human study step for a device used to open the angle during cataract surgery. The article targets regulatory, clinical and quality teams who need to track how new device concepts enter the human study process and what factors influence regulatory review and safety monitoring.
What changed
The ClinicalTrials.gov entry lists a trial in which a goniotomy procedure is performed during a combined phacoemulsification surgery. The conditions include Open Angle Glaucoma and its primary and secondary forms. The sponsor is Henry Ford Health System and the status is not yet recruiting. The entry confirms that the intervention is a Goniotomy performed in the context of a combined phacoemulsification procedure. The record signals that this is an early stage testing effort rather than a standalone glaucoma procedure. This is a regulatory signal that readers should monitor for future updates, as a transition from trial entry to results would influence device labeling and use guidance.
Context of goniotomy in glaucoma procedures
Goniotomy targets the drainage angle to improve aqueous outflow. In this trial it is paired with phacoemulsification cataract surgery, a common combined operation in glaucoma patients. The public record suggests the intention to study a device or technique in this setting, which could affect instrument compatibility, surgical workflow and postoperative care. Regulators would expect a clear description of the intended use, safety monitoring and endpoints in the protocol as the trial progresses.
Who is affected
The audience for this update includes regulatory professionals, ophthalmology device developers, clinical researchers and hospital quality teams who track new procedures and their regulatory implications. The trial context centers on open angle glaucoma patients, including primary open angle glaucoma and related secondary forms. The not yet recruiting status means no published results are available at this time. The sponsor is Henry Ford Health System. Readers should watch for updates that may influence patient selection criteria, consent language and risk communication in future regulatory submissions.
Context for related guidance can be found in internal references on ophthalmic device regulatory pathways and on views of combined cataract and glaucoma surgery. See Regulatory pathways for ophthalmic devices and Goniotomy with phacoemulsification in clinical practice.
What is the trial design
The entry lists an intervention of Goniotomy in the combined setting. The implied purpose is to inspect safety and performance in real world surgical practice, not to present final clinical outcomes. No endpoints, follow up periods or results are provided in the public record. The sponsor and participating sites will determine the trial architecture, data capture methods and statistical analysis aligned with regulatory expectations for novel ophthalmic devices. Regulators will look for details about device compatibility with phacoemulsification systems, patient safety monitoring and adverse event reporting in subsequent disclosures.
Intervention details and use
The public record specifies the intervention as Goniotomy performed during a combined cataract surgery. It does not disclose the device brand or the equipment configuration. Regulatory communications will require a precise description of the device, its intended use and the performance criteria used to assess safety and effectiveness in this specific surgical context.
Safety and performance signals
Because the record shows not yet recruiting, there are no results to analyze. Regulatory minded readers should expect future updates to present safety data, performance metrics and patient outcomes that will inform risk benefit assessments and potential labeling considerations for combined cataract and glaucoma care. The sponsor Henry Ford Health System will supervise the trial and ensure regulatory compliance. A link to the ClinicalTrials.gov record provides traceability for readers who want to review the official listing.
For reference see ClinicalTrials.gov NCT07418853 record at ClinicalTrials.gov NCT07418853.
Frequently Asked Questions
- 1. What is the trial about The trial tests a goniotomy procedure in the setting of a combined phacoemulsification surgery for open angle glaucoma.
- 2. Who sponsors the trial Henry Ford Health System is listed as the sponsor.
- 3. What is the recruitment status The record indicates not yet recruiting at this time.
- 4. Where is this trial listed The entry is on ClinicalTrials.gov under NCT07418853.
- 5. What should regulators monitor Look for protocol details, endpoints, safety monitoring plans and eventual results that inform labeling and use in practice.
Conclusion and next steps
This development indicates ongoing interest in combining glaucoma management with cataract surgery in a single procedure. Regulators and device developers should monitor trial updates and prepare to evaluate future results for safety, performance and labeling implications. Hospitals and eye care teams may see evolving guidance if the trial demonstrates favorable safety signals and clear performance benefits for a combined approach.
Readers should review the ClinicalTrials.gov page for the latest status and refer to sponsor communications when available. Tracking these regulatory signals helps ensure patient safety and clear expectations for device use in ophthalmic surgery.
Disclaimer: This article is intended for professionals and is not legal advice.
It provides informational content about a clinical trial record and regulatory considerations based on the source text.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07418853?term=medical+device