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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-04

Study Completion Date

2027-08-02

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma, Open Angle, Pseudo-exfoliative Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Tran cannula surgery

Patients treated with Tran cannula

Group Type EXPERIMENTAL

Tran canula

Intervention Type 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 surgery

Patients treated with augmented irrigation cannula.

Group Type ACTIVE_COMPARATOR

augmented irrigation

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

augmented irrigation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital Privé de la Baie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Privé de la Baie

Avranches, , France

Site Status RECRUITING

Fondation Rothschild

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Ana Miguel, MD

Role: CONTACT

+33 7 87 01 61 87

Facility Contacts

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Alice Grise-Dulac, MD

Role: primary

+33 6 70 71 28 85

Other Identifiers

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2023-23-PDB

Identifier Type: -

Identifier Source: org_study_id

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