Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy (PAINT)

Medical University Innsbruck

Status: Not yet enrolling

Conditions: Primary Open Angle Glaucoma; Pseudoexfoliation Glaucoma

Treatments: Device: Preserflo / Innfocus Microshunt; Other: Trabeculectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04440527

PAINT-Study

Details and patient eligibility

About

The aim of this project is to compare trabeculectomy with Preserflo / Innfocus Microshunt in patients with Primary Angle Open Glaucoma and Pseudoexfoliation Glaucoma regarding the reduction of intraocular pressure.

Full description

The study is a prospective, randomized, monocentric, part blinded, controlled non-inferiority study of glaucoma patients.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Primary open angle glaucoma or pseudoexfoliation glaucoma
• medically uncontrollable intraocular pressure or intolerance of topical therapy
• negative urine/serum pregnancy test of women in childbearing age
• signed and dated informed consent

Exclusion criteria

• previous incisional glaucoma procedure on affected eye
• pregnancy, nursing period
• Patients in military service, training periods and civil service
• Participation in another clinical trail
• pre-existing ocular pathologies: high myopia (refraction ≥8.00 D), thin conjunctiva

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

70 participants in 2 patient groups

Microshunt

Experimental group

Description:

Patients will be treated with Preserflo / Innfocus Microshunt (Santen Pharmaceutical Co., Ltd.).

Treatment:

Device: Preserflo / Innfocus Microshunt

Trabeculectomy

Active Comparator group

Description:

Patients will be treated with trabeculectomy.

Treatment:

Other: Trabeculectomy