Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation
NCT ID: NCT06979752
Last Updated: 2025-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
58 participants
INTERVENTIONAL
2025-06-04
2027-08-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tran cannula surgery
Patients treated with Tran cannula
Tran canula
After phacoemulsification, implantation of the intraocular implant and aspiration of the viscoelastic, we connect the TranCanula® to the irrigation system. Then we treat the trabecular mesh.
augmented irrigation surgery
Patients treated with augmented irrigation cannula.
augmented irrigation
After phacoemulsification, We use the classical aspiration cannula to irrigate the trabecular mesh.
Interventions
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Tran canula
After phacoemulsification, implantation of the intraocular implant and aspiration of the viscoelastic, we connect the TranCanula® to the irrigation system. Then we treat the trabecular mesh.
augmented irrigation
After phacoemulsification, We use the classical aspiration cannula to irrigate the trabecular mesh.
Eligibility Criteria
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Inclusion Criteria
* Reliable visual field, Humphrey 24-2, Sita-Fast, with typical glaucoma alterations, and with mean deviation ≤-12 dB.
* OCT with ganglion cell alterations and fibers typical of glaucoma.
* Typical glaucomatous neuropathy
* Slit-lamp signs of pseudoexfoliation.
* Open angle (2 to 4, according to Shaffer classification) determined by gonioscopy.
* Untreated eye pressure \>21 mmHg and \<33 mmHg
Exclusion Criteria
* History of intraocular surgery in the last 12 months, history of trauma
* History of laser trabeculoplasty (TLA or SLT) in the previous 12 months
* Visual acuity below "finger count
* Myopia ≥ 6 dioptres, hyperopia ≥ 5 dioptres
* Iridocorneal angle closure (and angle-closure glaucoma), any other type of non-pseudoexfoliative glaucoma, iris neovascularization
* Pachymetry \< 490 μm or \> 620 μm; or corneal pathology or other condition that makes accurate IOP measurements with flattening tonometry, ultrasonic pachymetry or specular microscopy impossible.
* Presence of severe systemic pathologies
18 Years
ALL
No
Sponsors
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Hôpital Privé de la Baie
OTHER
Responsible Party
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Locations
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Hôpital Privé de la Baie
Avranches, , France
Fondation Rothschild
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-23-PDB
Identifier Type: -
Identifier Source: org_study_id
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