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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Tran canula
Procedure/SurgeryAfter 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/SurgeryAfter phacoemulsification, We use the classical aspiration cannula to irrigate the trabecular mesh.
Treatment groups
Trial outcomes
Primary outcomes
Intraocular pressure measure
Sponsors and contacts
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