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

Glaucoma Clinical Trial

— MIMS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06213805
• Other study ID #: 2023-A02193-42
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: April 2024
• Source: Hôpital Privé de la Baie
• Contact: Ana Miguel, MD
• Phone: +33787016187
• Email: myworld_ana[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: February 28, 2026
• Est. primary completion date: January 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Privé de la Baie	Avranches
France	Clinique Thiers	Bordeaux
France	Fondation Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Privé de la Baie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Optical Coherence Tomography	high-resolution images of the retina and anterior segment	month 3, month 12
Secondary	Visual field test	Measure of visual field in degree (°)	month 3, month 12