Clinical trial NCT02177123: Post Market Study of the InnFocus MicroShunt
Official title: Post Market Study to Evaluate Safety and Effectiveness of the InnFocus Microshunt™ (MIDI Arrow) in Patients With Primary Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Keywords: glaucoma shunt
glaucoma drainage device
Lead sponsor: InnFocus Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-27
Enrollment: 107
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: Prospective, multicentric, single arm post market study to gather safety and effectiveness data on the CE Marked InnFocus MicroShunt (MIDI Arrow) device in primary open angle glaucoma patients

Detailed description: The purpose of this study is to collect additional safety and effectiveness data on the InnFocus MicroShunt (MIDI Arrow) in subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and/or where glaucoma progression warrants surgery.

Eligibility criteria: Inclusion Criteria:

1. Subject has mild to moderate primary open glaucoma where the intraocular pressure is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure greater than or equal to 18mmHg and less than or equal to 35mmHg while on glaucoma medications and/or where glaucoma progression warrants surgery.
2. Primary open angle glaucoma diagnosis based on glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities documented on slit lamp stereo biomicroscopy or in stereo disc photos:

   1. Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles.
   2. Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles.
   3. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.
   4. Disc rim or peripapillary retinal nerve fiber layer hemorrhages.

4) Subject willing to comply with study requirements. 5) Subject who has signed an approved informed consent form

Exclusion Criteria:

1. Active iris neovascularization, active proliferative retinopathy or other ophthalmic disease that could confound study results.
2. Iridocorneal endothelial syndrome.
3. Epithelial or fibrous downgrowth.
4. Secondary glaucoma such as post-trauma, pseudo-exfoliative, etc.
5. Chronic ocular inflammatory disease.
6. Prior argon laser, selective laser, or micropulse trabeculoplasty within 90 days of enrollment.
7. Inability to obtain accurate IOP measurement throughout the study. For example: a history of corneal surgery, corneal opacities or disease/pathology (Active corneal infection or Fuchs dystrophy are examples.).
8. Severe anterior or posterior blepharitis.
9. Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
10. Prior laser peripheral iridotomy.
11. Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
12. Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1.
13. Previous cyclodestructive procedure.
14. Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
15. Severe anterior or posterior blepharitis.
16. Unwilling to discontinue contact lens use after surgery.
17. Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
18. Presence of an anterior chamber IOL (AC-IOL).
19. Prior laser peripheral iridotomy.
20. Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery during the investigational period.
21. Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
22. Known allergy or other contraindication to Mitomycin C (MMC) drug.
23. Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1.
24. Any condition that prevents the investigational device implantation or trabeculectomy in the superior region of the study eye (e.g., peripheral anterior synechiae, scleral staphyloma or conjunctival scarring).
25. Diagnosed degenerative visual disorders not associated with existing glaucoma condition (e.g., advanced dry or wet macular degeneration or other retinal disorders, central retinal artery or vein occlusion) or choroidopathy (e.g., choroidal detachment, effusion, choroiditis, or neovascularization).
26. Central corneal thickness that is less than 450 microns or greater than 620 microns.
27. Previous cyclodestructive procedure.
28. Prior retinal laser procedure conducted for any purpose other than treatment of retinal tear or hole.
29. Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease.
30. Clinically significant sequelae from trauma (e.g., chemical burns, blunt trauma, etc.)
31. Ocular pathology or medical condition for which, in the investigator's judgment, the following factors would either place the subject at increased risk of complications or contraindicate device implantation or interfere with compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits),

    1. inability to reliably complete visual field testing over the course of the study,
    2. uncontrolled systemic disease (e.g. diabetes, hypertension) that could compromise their participation in the study.
    3. Disorders that pose a fall risk, as well as compromise ability to take a visual field exam and take glaucoma medications (e.g., Parkinson's disease),
    4. inability to discontinue use of blood thinners within the surgeon's standard preoperative or postoperative instructions.
    5. immunodeficiency concerns.
    6. known corticosteroid responders whose pressure increases would not allow them to withstand the postop corticosteroid regimen.
32. Intraocular silicone oil.
33. Ocular steroid use in the planned study eye or systemic steroid use anytime within three months of the procedure. (This would not include the use of inhaled or dermatologic steroids.)
34. Chemotherapy within six months of the screening visit.
35. Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
36. A requirement of general anesthesia for the procedure.
37. Bacterial conjunctivitis
38. Bacterial corneal ulcers
39. Endophthalmitis
40. Orbital cellulitis
41. Bacteremia or septicemia
42. Active scleritis
43. Uveitis
44. Severe dry eye syndrome
45. Severe myopia
46. Pseudo-exfoliative glaucoma

Primary outcomes:
measure: Number of Participants With Study Success
timeFrame: Month 6, 9, 12, and 24
Secondary outcomes:
measure: IOP Change
timeFrame: Day 1, Day 7, Week 4, Month 3, Month 6, Month 9, Month 12, and Month 24
Other outcomes:
measure: Number of Participants Requiring Supplemental Medical Therapy at M12 and M24
timeFrame: 12 and 24 Months
Locations:
city: Grenoble
country: France
facility: Clinique Ophtalmologique Universitaire de Grenoble, Hôpital A. Michallon - CHU de Grenoble
city: Paris
country: France
facility: Groupe hospitalier Paris Saint-Joseph, Service d'Ophtalmologie
city: Pessac
country: France
facility: Pole Ophtalmologique de la Clinique Mutualiste
city: Maastricht
country: Netherlands
facility: University Eye Clinic Maastricht
city: Madrid
country: Spain
facility: Clinicovision - Hospital Clinico San Carlos
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève, Policlinique d'Ophtalmologie
Study officials:
affiliation: InnFocus Inc.
name: Guy Van de Weyer, Optometrist
role: STUDY_DIRECTOR
References:
citation: Beckers HJM, Aptel F, Webers CAB, Bluwol E, Martinez-de-la-Casa JM, Garcia-Feijoo J, Lachkar Y, Mendez-Hernandez CD, Riss I, Shao H, Pinchuk L, Angeles R, Sadruddin O, Shaarawy TM. Safety and Effectiveness of the PRESERFLO(R) MicroShunt in Primary Open-Angle Glaucoma: Results from a 2-Year Multicenter Study. Ophthalmol Glaucoma. 2022 Mar-Apr;5(2):195-209. doi: 10.1016/j.ogla.2021.07.008. Epub 2021 Jul 28.