Evaluating a new minimally invasive surgery for glaucoma
Efficacy and Safety of Minimally Invasive Micro-Sclerostomy (MIMS) in Glaucoma Surgery
This study is testing a new, less invasive surgery for glaucoma to see if it leads to fewer complications and a quicker recovery compared to traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (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 | NCT06213805 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness and safety of a minimally invasive microsclerostomy (MIMS) procedure in patients requiring glaucoma surgery. It compares the outcomes of MIMS with traditional surgical methods, focusing on the incidence of complications and overall patient recovery. The ophthalmologist will monitor participants and gather clinical data to evaluate the benefits of this innovative approach. Patients are expected to experience fewer complications than those undergoing conventional surgery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific types of glaucoma who have not achieved adequate control of their condition through medication.
Not a fit: Patients with other significant eye conditions or those who have had previous intraocular surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could lead to safer and more effective treatment options for patients with glaucoma.
How similar studies have performed: While this approach is innovative, similar minimally invasive techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Avranches and 2 other locations
- Hôpital Privé de la Baie — Avranches, France (Recruiting)
- Clinique Thiers — Bordeaux, France (Active_not_recruiting)
- Fondation Rothschild — Paris, France (Active_not_recruiting)
Study contacts
- Principal investigator: Ana Miguel, MD — Hôpital Privé de la Baie
- Study coordinator: Ana Miguel, MD
- Email: myworld_ana@hotmail.com
- Phone: +33787016187
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.