Inferonasal MIMS® Procedure: Long-Term Follow-Up Extension Study

NCT06577857 | Recruiting

• 1 other identifier: MMS-EEU-8
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

A long-term (24 and 30 months) follow-up extension, prospective, non-interventional, open label study for data collection from subjects who underwent prior MIMS® inferonasal surgery, in continuation of the previous clinical investigation with the MIMS® Device (MMS-EEU-5).

Conditions

Open Angle Glaucoma

Keywords

Intraocular Pressure; MIMS; Inferonasal; Minimally Invasive Glaucoma Surgery; Trabeculectomy; Sclerostomy; MIGS

Outcome Measures

Primary Outcomes (6)

• Intraocular Pressure Change (Baseline to 24 months)

  Change in IOP from medicated baseline to 24 months post-MIMS® surgery

  Baseline to 24 months post-MIMS® surgery

• Intraocular Pressure Change (Baseline to 30 months)

  Change in IOP from medicated baseline to 30 months post-MIMS® surgery

  Baseline to 30 months post-MIMS® surgery

• Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 24 Months)

  Change in the number of topical IOP-lowering medications from medicated baseline to 24 months post-MIMS® surgery

  Medicated baseline to 24 months post-MIMS® surgery

• Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 30 Months)

  Change in the number of topical IOP-lowering medications from medicated baseline to 30 months post-MIMS® surgery

  Medicated baseline to 30 months post-MIMS® surgery

• Surgery Success Rate (24 months)

  Success rate 24 months post-MIMS® surgery

  24 months post-MIMS® surgery

• Surgery Success Rate (30 months)

  Success rate 30 months post-MIMS® surgery

  30 months post-MIMS® surgery

Secondary Outcomes (2)

• Postoperative Complication Safety Outcomes

  Baseline to 30 months post-MIMS® surgery

• Interventional Safety Outcomes

  Baseline to 30 months post-MIMS® surgery

Study Arms (1)

Inferonasal MIMS Surgery Cohort

Cohort that includes subjects that have undergone the MIMS® inferonasal surgery.

Device: Inferonasal Minimally Invasive Micro Sclerostomy

Interventions

Inferonasal Minimally Invasive Micro Sclerostomy DEVICE

The Inferonasal MIMS® procedure uses the proprietary MIMS® device, which creates a sclerostomy in the inferonasal quadrant of the eye.

Also known as: Inferonasal MIMS

Inferonasal MIMS Surgery Cohort

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of subjects of Armenian descent that underwent the MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment.

You may qualify if:

• \. Subject who underwent MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment

Sponsors & Collaborators

• Sanoculis Ltd: lead

Study Sites (1)

S. Malayan Eye Center

Yerevan, Armenia

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Central Study Contacts

Khan Lau, OD

CONTACT

8082862666; khan@sanoculis.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: November 4, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

AR (1)