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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHôpital Privé de la Baie

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tran canula

    Procedure/Surgery

    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/Surgery

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

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Tran cannula surgeryExperimental treatment 1 intervention
Group B: augmented irrigation surgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intraocular pressure measure

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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