Clinical trial NCT00772330: Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms
Official title: Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: MIDI Arrow
Glaucoma Drainage Device
GDD
InnFocus
Glaucoma treatment
Lead sponsor: InnFocus Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Unicentric, non-randomized, single arm safety and performance study which will be conducted in accordance with the applicable parts of CFR 21 and Standard EN-ISO 14155 I \& II: 2003 on clinical investigations with medical devices on human subjects and recommendations guiding physicians in biomedical research involving human subjects adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and later revisions

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Treatment Performance Success
timeFrame: 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:
measure: Maintenance of Pressure Control
timeFrame: 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:
measure: Procedure Feasibility
timeFrame: Day 1
measure: Time (in Minutes) Taken for the Procedure
timeFrame: Day 1
measure: Visual Acuity
timeFrame: Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60
measure: Visual Field
timeFrame: 60 Months
measure: Incidence of Glaucoma Re-operation
timeFrame: 60 Months
measure: Glaucoma Supplemental Medication
timeFrame: Day 1 thru Month 3, Month 6, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60
measure: Implant Migration
timeFrame: 60 Months
measure: Implant Encapsulation
timeFrame: 60 Months
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Laser Center
Study officials:
affiliation: Laser Center, Santo Domingo, Dominican Republic
name: Juan F Batlle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Batlle 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.