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

Last updated: April 4, 2024
Sponsor: Hôpital Privé de la Baie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Treatment

Minimally invasive microsclerostomy

Clinical Study ID

NCT06213805
2023-A02193-42
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥ 18 years old who agree to participate in the study having signed informedconsent
  • Primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma withindication for glaucoma surgery (defined as uncontrolled intraocular pressure orworsening of visual fields, despite maximum tolerated medical therapy) and openiridocorneal angle ( trabecular meshwork visible on gonioscopy, Shaffer classificationgrade 3-4) and healthy and mobile conjunctiva (without scars or adhesions).
  • Chronic angle closure glaucoma with indication for combined glaucoma and cataractsurgery

Exclusion

Exclusion Criteria:

  • Presence of other ophthalmological pathologies (except cataract)
  • History of intraocular surgery (unless cataract surgery), history of trauma, orconjunctival scarring in the quadrant planned for surgery
  • Visual acuity lower than "counts fingers" ", closure of the iridocorneal angle (andangle-closure glaucoma unless associated cataract surgery), neovascular glaucoma orneovascularization of the iris, pachymetry < 490 μm or > 620 μm.
  • Presence of severe systemic pathologies, pregnant or breastfeeding woman

Study Design

Total Participants: 23
Treatment Group(s): 1
Primary Treatment: Minimally invasive microsclerostomy
Phase:
Study Start date:
January 15, 2024
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • Hôpital Privé de la Baie

    Avranches, 50300
    France

    Active - Recruiting

  • Clinique Thiers

    Bordeaux, 33100
    France

    Site Not Available

  • Fondation Rothschild

    Paris, 75019
    France

    Site Not Available

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