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RecruitingNCT06979752Updated Sep 30, 2026

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

An interventional study of Tran canula and augmented irrigation in Glaucoma, Open Angle, Pseudo-exfoliative and Cataract, sponsored by Hôpital Privé de la Baie. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Hôpital Privé de la Baie · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Glaucoma, Open Angle, Pseudo-exfoliative
  • Cataract
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with cataract and early-to-moderate pseudoexfoliative glaucoma (GPX) scheduled for isolated cataract surgery.
  • 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

Exclusion Criteria:

  • Presence of other ophthalmological pathologies (except cataract or mild dry eye)
  • 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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
58 participants (estimated)

Study arms

  • Experimental
    Tran cannula surgery

    Patients treated with Tran cannula

    Procedure: Tran canula

  • Active comparator
    augmented irrigation surgery

    Patients treated with augmented irrigation cannula.

    Procedure: augmented irrigation

Interventions

  • ProcedureTran 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.

  • Procedureaugmented irrigation

    After phacoemulsification, We use the classical aspiration cannula to irrigate the trabecular mesh.

05

What researchers measure

Primary outcomes

  1. Intraocular pressure measure

    Time frame: day 1, day 30, month 3, month 6 and month 12 after surgery

06

Study locations

1 of 3 sites recruiting
  • Hôpital Privé de la Baie
    Avranches, France
    Recruiting
  • Fondation Rothschild
    Paris, France
    Active, not recruiting
  • Clinique de la Côte d'Emeraude
    St-Malo, 35400, France
    Not yet recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06979752
Lead sponsor
Hôpital Privé de la Baie
Responsible party
Sponsor
First posted
May 20, 2025
Start date
Jun 4, 2025
Primary completion
Feb 2, 2028 (estimated)
Completion
Feb 2, 2029 (estimated)
Last update
Sep 30, 2026

Study contacts

Ana Miguel, MD
Contact
myworld_ana@hotmail.com
+33 7 87 01 61 87

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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