Glaucoma Clinical Trial
Official title:
Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms
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 |
Verified date | June 2021 |
Source | InnFocus Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Dominican Republic | Laser Center | Santo Domingo |
Lead Sponsor | Collaborator |
---|---|
InnFocus Inc. |
Dominican Republic,
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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