Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

Sponsor
Hôpital Privé de la Baie
Study ID
NCT06979752
Status
Recruiting
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Conditions

  • Cataract
  • Glaucoma, Open Angle, Pseudo-exfoliative

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tran canula — PROCEDURE
    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 — PROCEDURE
    After phacoemulsification, We use the classical aspiration cannula to irrigate the trabecular mesh.

Study Details

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.

Key Dates

First listed
May 20, 2025
Start date
Jun 4, 2025
Status verified
Feb 2026
Primary completion
Feb 2, 2028
Completion
Feb 2, 2029

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tran cannula surgery
    Patients treated with Tran cannula
  • Active Comparator: augmented irrigation surgery
    Patients treated with augmented irrigation cannula.

Primary Outcome Measure

Intraocular pressure measure [ Time Frame: day 1, day 30, month 3, month 6 and month 12 after surgery ]

Central Contacts

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