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Completed

NCT Number: NCT06213805

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé de la Baie, Avranches, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimally invasive microsclerostomy

Procedure

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. visual quality of life VFQ-25,

    Time frame: month 1, month 3, month 12 after surgery

    25 questions about visual quality of life with Likert scale (1-5 and 1-6)

  2. Optical Coherence Tomography

    Time frame: month 3, month 12

    high-resolution images of the retina and anterior segment

  3. Visual field test

    Time frame: month 3, month 12

    Measure of visual field in degree (°)

Sponsors and collaborators

Lead sponsor

Hôpital Privé de la Baie

Other

Registry information

Acronym: MIMS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 19, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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