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

Launched by HÔPITAL PRIVÉ DE LA BAIE · May 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Tran cannula, which is designed to help with cataract surgery in patients who also have a specific type of glaucoma known as pseudoexfoliative glaucoma. This condition can make cataract surgery more complicated. The main goal of the trial is to see if using the Tran cannula is better at lowering eye pressure compared to using more fluid during surgery. Lowering eye pressure is important for managing glaucoma.

To participate in the trial, individuals need to be between 65 and 74 years old and have both cataracts and early to moderate pseudoexfoliative glaucoma. They should have certain eye test results that show typical signs of glaucoma and have untreated eye pressure levels between 21 and 33 mmHg. However, participants cannot have other serious eye conditions or recent eye surgeries. If someone joins the study, they can expect to undergo cataract surgery with either the Tran cannula or the standard method while being monitored for their eye pressure and overall safety during the procedure.

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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