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Completed

NCT Number: NCT07051174

The Minimally Invasive Micro Sclerostomy (MIMS®) System is Intended for the Reduction of Elevated Intraocular Pressure (IOP): The Minimally Invasive Micro Sclerostomy (MIMS®) System is Intended for the Reduction of Elevated Intraocular Pressure (IOP)

No new investigational device is used in this study. This study is an extension follow up study conducted in continuation of the prior MIMS® study (see: STUDY ID: MMS EEU-1), in which the long-term (i.e., 28, 36, 42 months) clinical outcomes of Minimally Invasive Micro Sclerostomy System [MIMS® System] [CE Marked device] are evaluated.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malayan

Yerevan, Armenia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female ≥ 18 years to ≤ 85 years old
  • Subject who underwent either standalone MIMS® surgery or MIMS® surgery in combination with phacoemulsification, in continuation of the previous clinical investigation with the MIMS® device (see: STUDY ID: MMS EEU-1), and surgery was performed not earlier than 2 years from enrollment
  • Subject who is considered complete success (i.e., 20% or greater reduction in IOP from Baseline on no medications) and qualified success (i.e., 20% or greater reduction in IOP from Baseline on the same or less number of medications) or failure with IOP >21mmHg with no medications at 1 year post MIMS® surgery (see: STUDY ID: MMS EEU-1)
  • Subject who is able and willing to attend all scheduled assessments
  • Subject understands and signs the informed consent

Exclusion criteria

  • Subject who was considered failure at 1 year after the MIMS® surgery
  • Any subject with major protocol deviation from the prior MIMS® study (ID: MMS EEU-1)
  • Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eye, since the MIMS® surgery in the study eye
  • Any ocular disease in the study eye such as severe dry eye, active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, and ocular pathology that may interfere with accurate IOP measurements
  • Any ocular surgery since the MIMS® surgery in the study eye
  • Severe trauma in the study eye since the MIMS® surgery in the study eye
  • Current participation or participation in another investigational drug or device clinical trial within the last 30 days before enrollment in the study
  • Pregnant or lactating women

Treatment and study plan

MIMS

Diagnostic Test

This study is an extension follow up study conducted in continuation of the prior MIMS® study (see: STUDY ID: MMS EEU-1), in which the long-term (i.e., 28, 36, 42 months) clinical outcomes of Minimally Invasive Micro Sclerostomy System [MIMS® System] [CE Marked device] are evaluated.

Primary outcomes

  1. Observed IOP at Long- Term ( >2 Years) post-MIMS® surgery:

    Time frame: 28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® surgery

    • IOP will be measured for subjects who have completed the MIMS® surgery and no earlier than 2 years from the procedure.

Secondary outcomes

  1. • IOP Levels at the following time points:

    Time frame: 28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® surgery

    IOP will be measured for subjects who have completed the MIMS® surgery and assessed at least one of the following visits (the data from more than one visit will be also collected):

    28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® surgery

Sponsors and collaborators

Lead sponsor

Sanoculis Ltd

Industry

Registry information

Official study title

Minimally Invasive Micro Sclerostomy System - Long- Term Follow-Up Extension Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 4, 2025
Registry last updated
Jul 4, 2025

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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