Actively Recruiting
Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation
Led by Hôpital Privé de la Baie · Updated on 2026-02-06
58
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with pseudoexfoliative glaucoma, a type of glaucoma caused by pseudoexfoliative syndrome, which can make cataract surgery more challenging and prone to complications. This study aims to compare the effectiveness of the Tran cannula, a single-use irrigation device designed to clean pseudoexfoliative material from the eyes drainage system, with increased irrigation using a traditional cannula. The goal is to see which method better lowers eye pressure in patients undergoing cataract surgery who also have glaucoma. Participants will be randomly assigned to one of two groups one treated with the Tran cannula and the other with augmented irrigation using a classical aspiration cannula. Both procedures are done after cataract removal, intraocular implant placement, and viscoelastic aspiration, focusing on cleaning the trabecular meshwork to manage eye pressure. This study uses a double-blind design to fairly compare these two surgical irrigation methods. During the study, researchers will measure intraocular pressure at several key times one day, 30 days, three months, six months, and twelve months after surgery. These measurements will help assess how well each irrigation technique controls eye pressure over time. Participants will be closely monitored throughout the year-long follow-up to evaluate safety and effectiveness of the procedures in managing glaucoma alongside cataract surgery.
CONDITIONS
Brief Title
Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with cataract and early-to-moderate pseudoexfoliative glaucoma scheduled for isolated cataract surgery
- Reliable visual field test with typical glaucoma changes and mean deviation 64 -12 dB
- OCT showing ganglion cell and fiber changes typical of glaucoma
- Typical glaucomatous optic nerve damage
- Slit-lamp signs of pseudoexfoliation
- Open eye angle (2 to 4 per Shaffer classification) by gonioscopy
- Untreated eye pressure greater than 21 mmHg and less than 33 mmHg
You will not qualify if you...
- Other eye diseases except cataract or mild dry eye
- Eye surgery or trauma history within the last 12 months
- Laser trabeculoplasty within the last 12 months
- Visual acuity below finger counting
- Myopia of 6 diopters or more, hyperopia of 5 diopters or more
- Angle-closure glaucoma or other non-pseudoexfoliative glaucoma types
- Iris neovascularization
- Corneal thickness less than 490 bcm or greater than 620 bcm, or corneal conditions preventing accurate eye pressure measurement
- Severe systemic diseases
Research Team
A
Ana Miguel, MD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here