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

Hôpital Privé de la Baie

Status: Enrolling

Conditions: Cataract; Glaucoma, Open Angle, Pseudo-exfoliative

Treatments: Procedure: Tran canula; Procedure: augmented irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT06979752

2023-23-PDB

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Tran cannula surgery

Experimental group

Description:

Patients treated with Tran cannula

Treatment:

Procedure: Tran canula

augmented irrigation surgery

Active Comparator group

Description:

Patients treated with augmented irrigation cannula.

Treatment:

Procedure: augmented irrigation