Status:
RECRUITING
Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation
Lead Sponsor:
Hôpital Privé de la Baie
Conditions:
Glaucoma, Open Angle, Pseudo-exfoliative
Cataract
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 de...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 2 2027
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06979752
Start Date
June 4 2025
End Date
August 2 2027
Last Update
June 13 2025
Active Locations (2)
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1
Hôpital Privé de la Baie
Avranches, France
2
Fondation Rothschild
Paris, France