NCT04503590

Brief Summary

Eligible Glaucoma patients will undergo pre-surgery examination including: medicines list, blood tests and ECG. On surgery day: intraocular pressure (IOP) will be measured. Then a sub-conjunctival injection of Mitomycin C will be administered . The Minimally Invasive Micro Sclerostomy (MIMS) procedure is designed to create a drainage channel at the sclera-corneal junction by penetrating through the wall \[scleral tissue\] . MIMS procedure may be combined with cataract surgery. Patients will be followed up to 52 weeks post operation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2022

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

3.2 years

First QC Date

August 4, 2020

Last Update Submit

November 27, 2022

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure Reduction

    Proportion of subjects achieved a 20% or greater reduction in IOP from Baseline on the same or less number of medications

    52 weeks

Secondary Outcomes (2)

  • Mean Intraocular Pressure

    52 weeks

  • Adverse Event

    52 weeks

Study Arms (1)

Minimally invasive micro sclerostomy (MIMS)

EXPERIMENTAL

create a drainage channel at the sclera-corneal junction

Device: Minimally Invasive Micro Sclerostomy (MIMS)

Interventions

Minimally Invasive Micro Sclerostomy (MIMS)DEVICE

The System is a surgical device, designed to create a drainage channel at the sclera-corneal junction . The drainage channel is created by a Stainless Steel surgical tool.

Minimally invasive micro sclerostomy (MIMS)

Eligibility Criteria

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

You may qualify if:

  • Male or female ≥ 18 years
  • Primary open-angle glaucoma,pseudoexfoliation glaucoma or pigmentary glaucoma in the study eye
  • Optic nerve appearance characteristic of glaucoma in the study eye
  • Patient is treated with 0 to 5 hypotensive medications in the study eye
  • Unsatisfactory IOP (≥ 21 mmHg) at the screening visit in the study eye
  • If cataract is not present - 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:

  • Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
  • Closed angle forms of glaucoma in either eye unless scheduled for cataract surgery immediately prior to the MIMS procedure or the study eye is pseudophakic with PCIOL.
  • 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
  • Best-corrected visual acuity worse than 20/40 (Snellen equivalent) in the fellow eye
  • 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
  • Vitreous present in anterior chamber, prior vitrectomy or virteous hemorrhage in study eye
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.V.Malayan'S Eye Center

Yerevan, 0048, Armenia

Location

Related Publications (1)

  • Voskanyan L, Ahmed IIK, Gershoni A, Barayev E, Papoyan V, Ghazaryan A, Bar-Ilan O, Zahavi A, Glovinsky Y, Geffen N. Minimally invasive micro sclerostomy (MIMS) procedure in the treatment of open-angle glaucoma. BMC Ophthalmol. 2024 Mar 18;24(1):122. doi: 10.1186/s12886-024-03384-y.

    PMID: 38494493DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

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

August 4, 2020

First Posted

August 7, 2020

Study Start

May 29, 2019

Primary Completion

August 11, 2022

Study Completion

August 11, 2022

Last Updated

November 30, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)