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NCT Number: NCT06979752

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

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.

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Key information

Conditions

Glaucoma, Open Angle, Pseudo-exfoliative Cataract Eye Diseases Glaucoma Lens Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé de la Baie, Avranches, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Intraocular pressure measure

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Miguel, MD

CONTACT

[email protected]

+33 7 87 01 61 87

Sponsors and collaborators

Lead sponsor

Hôpital Privé de la Baie

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
May 20, 2025
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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