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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00772330
Other study ID # INN003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2007
Est. completion date January 2017

Study information

Verified date June 2021
Source InnFocus Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date January 2017
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Glaucoma Drainage Device
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

Locations

Country Name City State
Dominican Republic Laser Center Santo Domingo

Sponsors (1)

Lead Sponsor Collaborator
InnFocus Inc.

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type Measure Description Time frame Safety issue
Other Procedure Feasibility Defined by ease of insertion of the device into the anterior chamber, based on an Investigator evaluation rating (5-point scale, with 1 being difficult and 5 being easy); Day 1
Other Time (in Minutes) Taken for the Procedure The mean surgical procedure time from the time the incision was made in the conjunctiva to the time peritomy closure Day 1
Other Visual Acuity Visual acuity measured at each post-operative visit from baseline. Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60
Other Visual Field Visual field measure at each post op visit. Data not available for summary as per CSR 60 Months
Other Incidence of Glaucoma Re-operation Cases requiring glaucoma re-operation 60 Months
Other Glaucoma Supplemental Medication The number of glaucoma supplemental medications required after the MicroShunt procedure. Day 1 thru Month 3, Month 6, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60
Other Implant Migration Incidence of implant migration. None reported 60 Months
Other Implant Encapsulation Incidence of implant encapsulation. None reported 60 Months
Primary 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 Maintenance of Pressure Control Maintenance of pressure control throughout the follow-up period, as measured by IOP at each post-operative visit Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60
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