NCT06979752

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
34mo left

Started Jun 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Jun 2025Feb 2029

First Submitted

Initial submission to the registry

May 12, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

June 4, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2029

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

May 12, 2025

Last Update Submit

February 5, 2026

Conditions

Glaucoma, Open Angle, Pseudo-exfoliativeCataract

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure measure

    day 1, day 30, month 3, month 6 and month 12 after surgery

Study Arms (2)

Tran cannula surgery

EXPERIMENTAL

Patients treated with Tran cannula

Procedure: Tran canula

augmented irrigation surgery

ACTIVE COMPARATOR

Patients treated with augmented irrigation cannula.

Procedure: augmented irrigation

Interventions

Tran canulaPROCEDURE

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.

Tran cannula surgery
augmented irrigationPROCEDURE

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

augmented irrigation surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Privé de la Baie

Avranches, France

RECRUITING

Fondation Rothschild

Paris, France

RECRUITING

Clinique de la Côte d'Emeraude

St-Malo, 35400, France

NOT YET RECRUITING

MeSH Terms

Conditions

GlaucomaCataract

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesLens Diseases

Central Study Contacts

Ana Miguel, MD

CONTACT

+33 7 87 01 61 87myworld_ana@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2025

First Posted

May 20, 2025

Study Start

June 4, 2025

Primary Completion (Estimated)

February 2, 2028

Study Completion (Estimated)

February 2, 2029

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)