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
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pseudoexfoliative glaucoma is a glaucoma secondary to pseudoexfoliative syndrome; cataract surgery is often more difficult, with more complications. Tran's cannula is a single-use irrigation system designed for cleaning, with the pseudoexfoliative material remaining in the trabecular meshwork. The main objective of this study is to evaluate the efficacy of the Tran cannula, in comparison with increased irrigation, in lowering intraocular pressure (IOP) in patients with pseudoexfoliative glaucoma and treated for glaucoma, and with an indication for isolated cataract surgery.
CONDITIONS
Official 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 3 dB or less
- Optical coherence tomography showing glaucoma-related ganglion cell and fiber changes
- Typical glaucomatous optic nerve damage
- Slit-lamp signs of pseudoexfoliation
- Open angle (2 to 4 by Shaffer classification) confirmed by gonioscopy
- Untreated eye pressure above 21 mmHg and below 33 mmHg
You will not qualify if you...
- Other eye diseases except cataract or mild dry eye
- History of intraocular surgery or eye trauma in the last 12 months
- History of laser trabeculoplasty in the last 12 months
- Visual acuity worse than finger counting
- Myopia of 6 diopters or more, hyperopia of 5 diopters or more
- Iridocorneal angle closure or non-pseudoexfoliative glaucoma types
- Iris neovascularization
- Corneal thickness below 490 bc or above 620 bc, or corneal conditions preventing accurate eye pressure measurement
- Severe systemic diseases
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Hôpital Privé de la Baie
Avranches, France
Actively Recruiting
2
Fondation Rothschild
Paris, France
Actively Recruiting
3
Clinique de la Côte d'Emeraude
St-Malo, France, 35400
Not Yet Recruiting
Research Team
A
Ana Miguel, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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