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

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Hôpital Privé de la Baie

Status

Enrolling

Conditions

Glaucoma

Treatments

Procedure: Minimally invasive microsclerostomy

Study type

Interventional

Funder types

Other

Identifiers

NCT06213805
2023-A02193-42

Details and patient eligibility

About

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.

Enrollment

23 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 1 patient group

Minimally invasive microsclerostomy
Experimental group
Treatment:
Procedure: Minimally invasive microsclerostomy

Trial contacts and locations

3

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Central trial contact

Ana Miguel, MD

Data sourced from clinicaltrials.gov

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