Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tran canula, augmented irrigation.
- Who it may be relevant to
- Registry conditions: Glaucoma, Open Angle, Pseudo-exfoliative, Cataract. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure 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. - Procedure augmented irrigation
After phacoemulsification, We use the classical aspiration cannula to irrigate the trabecular mesh.
Primary outcome measures
- Intraocular pressure measure [Time frame: day 1, day 30, month 3, month 6 and month 12 after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
France · 3 centers
- Hôpital Privé de la Baie — Avranches
- Fondation Rothschild — Paris
- Clinique de la Côte d'Emeraude — St-Malo
Identifiers
NCT: NCT06979752 · 2023-23-PDB