Canaloplasty device for open-angle glaucoma during cataract surgery
A Prospective, Multicenter, First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the DF12 CANALOPLASTY AND TRABECULOTOMY SURGICAL SYSTEM in Subjects With Open-Angle Glaucoma Undergoing Cataract Surgery
This test will try a canaloplasty device to lower eye pressure in people with open-angle glaucoma who are having cataract surgery and have an unmedicated IOP of 22–34 mmHg.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | New World Medical, Inc. Industry-sponsored |
| Locations | 3 sites (Santiago and 2 other locations) |
| Trial ID | NCT05696561 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls patients with open-angle glaucoma who are eligible for cataract surgery and have had a medication washout to document an unmedicated intraocular pressure (IOP) of 22–34 mmHg. During the cataract procedure the investigational canaloplasty device is placed to improve aqueous outflow through the conventional pathway. Participants are followed for safety and changes in IOP and glaucoma medication use over scheduled postoperative visits. The trial focuses on device-related adverse events and the device's ability to lower IOP when combined with cataract surgery.
Who should consider this trial
Good fit: Adults with open-angle glaucoma who qualify for cataract surgery, can be washed out of IOP-lowering medications, and have an unmedicated IOP of 22–34 mmHg are the intended participants.
Not a fit: Patients who cannot discontinue glaucoma medications, who have types of glaucoma other than open-angle, or whose IOP is outside the 22–34 mmHg range are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, the device could lower intraocular pressure and reduce the need for glaucoma medications when performed alongside cataract surgery.
How similar studies have performed: Prior canaloplasty and other micro‑incisional glaucoma procedures have demonstrated IOP reduction in published studies, so the general approach has precedent though device-specific results vary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects qualifying for cataract surgery 2. Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 22-34 mmHg. Exclusion Criteria: 1\. Patients who cannot be washed-out of IOP-lowering medications.
Where this trial is running
Santiago and 2 other locations
- Centro de la Vision — Santiago, Chile (Recruiting)
- Clínica 20/20 — San José, Costa Rica (Recruiting)
- Centro Oftalmologico Robles — Santa Rosa de Copán, Honduras (Not_yet_recruiting)
Study contacts
- Study coordinator: Swetha Mandava, MS
- Email: smandava@newworldmedical.com
- Phone: 9732049467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.