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

Not Applicable

Recruiting

• Conditions: Glaucoma
• Interventions: Procedure: Minimally invasive microsclerostomy

• Registration Number: NCT06213805
• Lead Sponsor: Hôpital Privé de la Baie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-10
• Study Start: 2024-01-15
• Study First Posted: 2024-01-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05
• Primary Completion: 2026-01-15
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Minimally invasive microsclerostomy	Minimally invasive microsclerostomy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Visual field test	month 3, month 12	Measure of visual field in degree (°)
Optical Coherence Tomography	month 3, month 12	high-resolution images of the retina and anterior segment
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)

Trial Locations

Locations (3)

Clinique Thiers; 🇫🇷 Bordeaux, France

Hôpital Privé de la Baie; 🇫🇷 Avranches, France

Fondation Rothschild; 🇫🇷 Paris, France