Status:
RECRUITING
Efficacy and Safety of Minimally Invasive Micro-Sclerostomy (MIMS) in Glaucoma Surgery
Lead Sponsor:
Hôpital Privé de la Baie
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective is to evaluate the effectiveness of MIMS in patients with an indication for glaucoma surgery, compared to traditional surgery. The secondary objective is to assess safety. The inves...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years old who agree to participate in the study having signed informed consent
- Primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma with indication for glaucoma surgery (defined as uncontrolled intraocular pressure or worsening of visual fields, despite maximum tolerated medical therapy) and open iridocorneal angle ( trabecular meshwork visible on gonioscopy, Shaffer classification grade 3-4) and healthy and mobile conjunctiva (without scars or adhesions).
- Chronic angle closure glaucoma with indication for combined glaucoma and cataract surgery
Exclusion
- Presence of other ophthalmological pathologies (except cataract)
- History of intraocular surgery (unless cataract surgery), history of trauma, or conjunctival scarring in the quadrant planned for surgery
- Visual acuity lower than "counts fingers" ", closure of the iridocorneal angle (and angle-closure glaucoma unless associated cataract surgery), neovascular glaucoma or neovascularization of the iris, pachymetry \< 490 μm or \> 620 μm.
- Presence of severe systemic pathologies, pregnant or breastfeeding woman
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT06213805
Start Date
January 15 2024
End Date
February 28 2026
Last Update
April 5 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Privé de la Baie
Avranches, France, 50300
2
Clinique Thiers
Bordeaux, France, 33100
3
Fondation Rothschild
Paris, France, 75019