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Clinical Trials/NCT06213805
NCT06213805
Recruiting
Not Applicable

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

Hôpital Privé de la Baie3 sites in 1 country23 target enrollmentStarted: January 15, 2024Last updated:
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ConditionsGlaucoma

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Hôpital Privé de la Baie
Enrollment
23
Locations
3
Primary Endpoint
Measurement of intraocular pressure by tonometry
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Measurement of intraocular pressure by tonometry

Time Frame: day 0, day 7, day 14, day 30, month 6, month 9 and month 12 after surgery

Measure in millimeters of mercury (mmHg)

Secondary Outcomes

  • Optical Coherence Tomography(month 3, month 12)
  • visual quality of life VFQ-25,(month 1, month 3, month 12 after surgery)
  • Visual field test(month 3, month 12)

Investigators

Sponsor
Hôpital Privé de la Baie
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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