CompletedNCT06213805MIMSUpdated Apr 1, 2026

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

An interventional study of Minimally invasive microsclerostomy in Glaucoma, sponsored by Hôpital Privé de la Baie. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by Hôpital Privé de la Baie · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 23
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

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.

Conditions studied

Glaucoma

Browse trials for

Glaucoma 1,816

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 23 participants (actual)

Study arms

Experimental
Minimally invasive microsclerostomy
Procedure: Minimally invasive microsclerostomy

Interventions

ProcedureMinimally 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 researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

3 sites

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT06213805
Lead sponsor: Hôpital Privé de la Baie
Responsible party: Sponsor
First posted: Jan 19, 2024
Start date: Jan 15, 2024
Primary completion: Mar 26, 2026
Completion: Mar 26, 2026
Last update: Apr 1, 2026

Study contacts

Ana Miguel, MD

principal investigator · Hôpital Privé de la Baie

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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