GlaucomaMIMSNCT06213805
Efficacy and Safety of Minimally Invasive Micro-Sclerostomy (MIMS) in Glaucoma Surgery
A study testing Minimally invasive microsclerostomy in people with Glaucoma, run by Hôpital Privé de la Baie at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Minimally invasive microsclerostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 3 sitesFrance
- Study dates
- 15 Jan 2024to 26 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Privé de la Baie
Avranches, 50300
Clinique Thiers
Bordeaux, 33100
Fondation Rothschild
Paris, 75019
About this study
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
- Glaucoma
- Being tested
- Minimally invasive microsclerostomy
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive microsclerostomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive microsclerostomy | Experimental | Not described Receives: Procedure: Minimally invasive microsclerostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of intraocular pressure by tonometry
Measure in millimeters of mercury (mmHg)
Measured: day 0, day 7, day 14, day 30, month 6, month 9 and month 12 after surgery
Secondary outcomes (3)
visual quality of life VFQ-25,
25 questions about visual quality of life with Likert scale (1-5 and 1-6)
Measured: month 1, month 3, month 12 after surgery
Optical Coherence Tomography
high-resolution images of the retina and anterior segment
Measured: month 3, month 12
Visual field test
Measure of visual field in degree (°)
Measured: month 3, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start15 Jan 2024
- Primary completion26 Mar 2026
- Study completion26 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Privé de la Baie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Miguel, MD, Principal investigator, Hôpital Privé de la Baie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213805
- Sponsor's protocol ID
- 2023-A02193-42
- Acronym
- MIMS
- Status last verified
- Mar 2026
- First submitted
- 10 Jan 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Minimally Invasive Micro-Sclerostomy (MIMS) in Glaucoma Surgery
- ClinicalTrials.gov ID
- NCT06213805
- Acronym / sponsor ID
- MIMS / 2023-A02193-42
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hôpital Privé de la BaieUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 26 Mar 2026 (actual)
- Study completion
- 26 Mar 2026 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive microsclerostomy | Experimental | Procedure: Minimally invasive microsclerostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive microsclerostomyMIMS 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. | Procedure or surgery | Minimally invasive microsclerostomy |
Primary outcome
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)
3 secondary outcomes
visual quality of life VFQ-25,
Time frame: month 1, month 3, month 12 after surgery
Optical Coherence Tomography
Time frame: month 3, month 12
Visual field test
Time frame: month 3, month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Miguel, MD principal investigator
Hôpital Privé de la Baie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive microsclerostomy in people with Glaucoma, run by Hôpital Privé de la Baie at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.