NCT02355990

Brief Summary

The study objective is to demonstrate the safety of Minimally Invasive Micro Sclerostomy (MIMS) device for lowering elevated IOP in patients diagnosed with glaucoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

3.9 years

First QC Date

January 31, 2015

Last Update Submit

November 27, 2022

Conditions

Primary Open Angle GlaucomaPigmentary GlaucomaPseudoexfoliative Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Overall incidence of serious adverse events

    12 weeks

Secondary Outcomes (3)

  • Incidence of serious adverse events

    24 weeks

  • intraocular pressure (IOP) between 6 mmHg and 15 mmHg without medication

    24 weeks

  • Change in number of glaucoma medications from baseline in the study eye

    24 weeks

Study Arms (1)

MIMS

EXPERIMENTAL

Minimally Invasive Micro Sclerostomy

Procedure: Minimally Invasive Micro Sclerostomy

Interventions

Minimally Invasive Micro SclerostomyPROCEDURE

Creation of a drainage channel of 50 - 100 microns (diameter) at the sclera-corneal junction and extending from the anterior chamber to the interface between the sclera and the conjunctiva (subconjuctival space).

MIMS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • End Stage primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma in the study eye (EGS criteria)
  • Optic nerve appearance characteristic of glaucoma in the study eye
  • Best-corrected visual acuity (BCVA) of counting-fingers, hand movements, light perception or no light perception due to glaucomatous loss of central vision in the study eye
  • Patient is treated with 1 to 5 hypotensive medications in the study eye
  • Unsatisfactory medicated IOP (≥ 18 mmHg) at the screening visit in the study eye
  • Shaffer grade ≥ III in all four angle quadrants in the study eye
  • Subject is able and willing to attend all scheduled follow-up exams
  • Subject understands and signs the informed consent

You may not qualify if:

  • Subjects presenting 1 or more of the following criteria will not be enrolled in the trial:
  • Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
  • Closed angle forms of glaucoma in either eye
  • Congenital or developmental glaucoma in either eye
  • Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eye
  • Peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities in the study eye
  • Subject has history of penetrating keratoplasty (PKP)
  • Any previous surgery in the study eye (except for clear corneal cataract surgery) where the conjunctiva is not intact and elastic.
  • Any ocular disease or history in 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
  • Prior surgery for an ab-interno or ab-externo device implanted in or through the Schlemm's canal in the study eye.
  • Use of oral hypotensive medication for glaucoma for treatment of the fellow eye
  • Less than the minimum visual function required for driving in the fellow eye: best-corrected visual acuity worse than 20/40 (Snellen equivalent) or Esterman visual field score less than 85%.
  • History of idiopathic or autoimmune uveitis in either eye
  • Severe trauma in study eye
  • active iris neovascularization, previous cyclodestructive procedure, prior scleral buckling procedure, presence of silicone oil, need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery in study eye within 12 month period
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldschleger Eye Institute, The Chaim Sheba Medical Center

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Daniel Cotlear, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2015

First Posted

February 4, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2019

Study Completion

December 15, 2020

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations

IL(1)