Glaucoma
Conditions
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 investigating ophthalmologist will follow the patients and collect clinical data in order to identify the benefits and complications of MIMS. Patients are expected to experience fewer complications compared to traditional glaucoma surgery.
Interventions
PROCEDUREMinimally invasive microsclerostomy
MIMS is a filtering glaucoma surgery, which consists of creating a sclero-corneal drainage channel, to allow the flow of aqueous humor and therefore the reduction of intraocular pressure. This surgery is extremely quick, lasting 3 to 5 minutes, according to recent MIMS studies, in contrast to the duration of a trabeculectomy, the classic glaucoma surgery, which varies between 20 and 60 minutes.
Sponsors
Hôpital Privé de la Baie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of intraocular pressure by tonometry | day 0, day 7, day 14, day 30, month 6, month 9 and month 12 after surgery | Measure in millimeters of mercury (mmHg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| visual quality of life VFQ-25, | month 1, month 3, month 12 after surgery | 25 questions about visual quality of life with Likert scale (1-5 and 1-6) |
| Optical Coherence Tomography | month 3, month 12 | high-resolution images of the retina and anterior segment |
| Visual field test | month 3, month 12 | Measure of visual field in degree (°) |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAna Miguel, MD
Hôpital Privé de la Baie
Outcome results
None listed