RecruitingNot ApplicableNCT06213805

Efficacy and Safety of Minimally Invasive Micro-Sclerostomy (MIMS) in Glaucoma Surgery


Sponsor

Hôpital Privé de la Baie

Enrollment

23 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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

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.


Locations(3)

Hôpital Privé de la Baie

Avranches, France

Clinique Thiers

Bordeaux, France

Fondation Rothschild

Paris, France

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NCT06213805


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