Health TrialsbyHealthPanel

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

ConditionOpen Angle Glaucoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-85
SponsorSanoculis Ltd

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

53 Participants
are divided into 1 treatment group
Group A: Inferonasal MIMS Surgery Cohort1 intervention

Trial outcomes

Primary outcomes

1

Intraocular Pressure Change (Baseline to 24 months)

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

Time frame
Baseline to 24 months post-MIMS® surgery
2

Intraocular Pressure Change (Baseline to 30 months)

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

Time frame
Baseline to 30 months post-MIMS® surgery
3

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

Time frame
Medicated baseline to 24 months post-MIMS® surgery
4

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

Time frame
Medicated baseline to 30 months post-MIMS® surgery

Secondary outcomes

1

Postoperative Complication Safety Outcomes

Late (greater than 12 months) postoperative complications

Time frame
Baseline to 30 months post-MIMS® surgery
2

Interventional Safety Outcomes

Late (greater than 12 months) postoperative interventions

Time frame
Baseline to 30 months post-MIMS® surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanoculis Ltd

Lead sponsor

Source ClinicalTrials.gov
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