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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpital Privé de la Baie
RECRUITING
Avranches
Fondation Rothschild
RECRUITING
Paris
Contact Information
Primary
Ana Miguel, MD
myworld_ana@hotmail.com
+33 7 87 01 61 87
Time Frame
Start Date: 2025-06-04
Estimated Completion Date: 2027-08-02
Participants
Target number of participants: 58
Treatments
Experimental: Tran cannula surgery
Patients treated with Tran cannula
Active_comparator: augmented irrigation surgery
Patients treated with augmented irrigation cannula.
Sponsors
Leads: Hôpital Privé de la Baie

This content was sourced from clinicaltrials.gov