Tran cannula versus augmented irrigation during cataract surgery for pseudoexfoliative glaucoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients with early-to-moderate pseudoexfoliative open-angle glaucoma scheduled for isolated cataract surgery will receive either cleaning with the single-use Tran cannula or augmented ocular irrigation during the procedure. The Tran cannula is designed to clear pseudoexfoliative material from the trabecular meshwork, and investigators will compare postoperative intraocular pressure and safety between the two approaches. Eligible participants must have typical glaucomatous field and OCT changes, open angles by gonioscopy, and untreated eye pressure between 21 and 33 mmHg. Follow-up will monitor IOP outcomes and procedure-related complications.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpital Privé de la Baie
  Avranches, France Recruiting
• Fondation Rothschild
  Paris, France Active not recruiting
• Clinique de la Côte d'Emeraude
  St-Malo, France Not yet recruiting

Study contacts

• Study coordinator: Ana Miguel, MD
• Email: myworld_ana@hotmail.com
• Phone: +33 7 87 01 61 87

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.