Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms

Glaucoma Clinical Trial

Official title:

Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772330
• Other study ID #: INN003
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Glaucoma

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