Tran cannula versus augmented irrigation during cataract surgery for pseudoexfoliative glaucoma
Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation
This study will test whether using the single-use Tran cannula during cataract surgery lowers intraocular pressure more than increased irrigation for people with early-to-moderate pseudoexfoliative glaucoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hôpital Privé de la Baie Academic / other |
| Locations | 3 sites (Avranches and 2 other locations) |
| Trial ID | NCT06979752 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people with early-to-moderate pseudoexfoliative open-angle glaucoma who need isolated cataract surgery and have untreated intraocular pressure between 21 and 33 mmHg.
Not a fit: Patients with advanced glaucoma, angle-closure glaucoma, other significant ocular disease, recent intraocular surgery or laser, or very poor visual acuity are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the Tran cannula could produce greater and more sustained IOP lowering after cataract surgery, potentially slowing glaucoma progression and reducing medication needs.
How similar studies have performed: Irrigation and flushing approaches to remove exfoliative material have been explored previously, but the specific single-use Tran cannula device is relatively new and not yet widely validated in large studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Avranches and 2 other locations
- Hôpital Privé de la Baie — Avranches, France (Recruiting)
- Fondation Rothschild — Paris, France (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.