Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms
1 other identifier
interventional
23
1 country
1
Brief Summary
Assess the safety and performance of the Miami InnFocus Drainage Implant in patients suffering from glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2007
Longer than P75 for not_applicable
1 active site
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
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 13, 2008
CompletedFirst Posted
Study publicly available on registry
October 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
July 14, 2021
CompletedJuly 14, 2021
June 1, 2021
9.1 years
October 13, 2008
January 26, 2021
June 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment Performance Success
Success: IOP \< 15 mmHg or IOP reduced from baseline (pre-operative level) by ≥ 20% (without glaucoma reoperation, such as a trabeculectomy to improve aqueous drainage or implantation of another drainage implant).
Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60
Secondary Outcomes (1)
Maintenance of Pressure Control
Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60
Other Outcomes (8)
Procedure Feasibility
Day 1
Time (in Minutes) Taken for the Procedure
Day 1
Visual Acuity
Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60
- +5 more other outcomes
Study Arms (1)
MIDI Arrow
EXPERIMENTALAb externo glaucoma drainage device with no reservoir
Interventions
Insertion of MIDI Arrow subconjunctivally with a fornix-based incision after pretreatment of scleral surface with 0.4 mg/mL MMC and insertion of MIDI Arrow tube through sclera into anterior chamber of eye
Eligibility Criteria
You may qualify if:
- Male or female, age 18 to 85 years, inclusive
- Glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg.
- Patient must have signed informed consent form
You may not qualify if:
- Unwilling or unable to give informed consent or unable to return for scheduled protocol visits
- Pregnant or nursing women
- No light perception
- Active iris neovascularization or active proliferative retinopathy
- Iridocorneal endothelial syndrome
- Epithelial or fibrous downgrowth
- Aphakia (without pseudophakia)
- Vitreous in anterior chamber for which a vitrectomy is anticipated
- Chronic or recurrent uveitis
- Severe posterior blepharitis
- Unwilling to discontinue contact lens use after surgery
- Previous ophthalmic surgery, excluding uncomplicated phacoemulsification (cataract) surgery or corneal refractive surgery
- Need for glaucoma surgery combined with other ocular procedures other than cataract surgery (i.e., penetrating keratoplasty or retinal surgery) or anticipated need for additional ocular surgery
- Known allergy to Mitomycin C (MMC) drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InnFocus Inc.lead
Study Sites (1)
Laser Center
Santo Domingo, Dominican Republic
Related Publications (2)
Garcia-Feijoo J, Batlle JF, Aptel F, Lachkar Y, Riss I, Sadruddin O, Nguyen T, Beckers HJM. Pooled Analysis of Three MicroShunt Studies in Primary Open-Angle Glaucoma Evaluating Different Concentrations of Applied Mitomycin C. Ophthalmol Ther. 2025 Jul;14(7):1533-1549. doi: 10.1007/s40123-025-01149-4. Epub 2025 May 23.
PMID: 40408035DERIVEDBatlle JF, Corona A, Albuquerque R. Long-term Results of the PRESERFLO MicroShunt in Patients With Primary Open-angle Glaucoma From a Single-center Nonrandomized Study. J Glaucoma. 2021 Mar 1;30(3):281-286. doi: 10.1097/IJG.0000000000001734.
PMID: 33137019DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sharon Herbert, Associate Director of Clinical Operations
- Organization
- InnFocus, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Juan F Batlle, MD
Laser Center, Santo Domingo, Dominican Republic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
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
October 13, 2008
First Posted
October 15, 2008
Study Start
October 1, 2007
Primary Completion
November 1, 2016
Study Completion
January 1, 2017
Last Updated
July 14, 2021
Results First Posted
July 14, 2021
Record last verified: 2021-06