N/A
Completed N=23
Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms
Source: ClinicalTrials.gov NCT00772330 ↗Enrolled (actual)
23
Serious AEs
34.8%
Results posted
Jul 2021
Primary outcomePrimary: Number of Participants With Treatment Performance Success — 22; 23; 23; 23 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Performance Success |
22; 23; 23; 23; 22; 23 | — |
| SECONDARY Maintenance of Pressure Control |
23.78; 9.6; 7.8; 7.4; 8.9; 10.8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00772330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.