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

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 Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Procedure: Minimally invasive microsclerostomy

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Avranches, France, 50300
    • Hôpital Privé de la Baie
  • Bordeaux, France, 33100
    • Clinique Thiers
  • Paris, France, 75019
    • Fondation Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Minimally invasive microsclerostomy

Procedure: Minimally 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of intraocular pressure by tonometry	Measure in millimeters of mercury (mmHg)	day 0, day 7, day 14, day 30, month 6, month 9 and month 12 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual quality of life VFQ-25,	25 questions about visual quality of life with Likert scale (1-5 and 1-6)	month 1, month 3, month 12 after surgery
Optical Coherence Tomography	high-resolution images of the retina and anterior segment	month 3, month 12
Visual field test	Measure of visual field in degree (°)	month 3, month 12

Collaborators and Investigators

• Sponsor: Hôpital Privé de la Baie
• Investigators: Principal Investigator: Ana Miguel, MD, Hôpital Privé de la Baie

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): March 26, 2026
• Study Completion (Actual): March 26, 2026

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 2023-A02193-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No