PAINT: Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy

• Sponsor: Medical University Innsbruck (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04440527
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma; Pseudoexfoliation Glaucoma	Device: Preserflo / Innfocus Microshunt; Other: Trabeculectomy	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Intraocular Pressure After Preserflo /Innfocus Microshunt vs Trabeculectomy: a Prospective, Randomised Control-trial (PAINT-Study)
• Anticipated Study Start Date: Jul 22, 2020
• Anticipated Primary Completion Date: Jul 22, 2022
• Anticipated Study Completion Date: Jul 22, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Microshunt Patients will be treated with Preserflo / Innfocus Microshunt (Santen Pharmaceutical Co., Ltd.).	Device: Preserflo / Innfocus Microshunt; The Microshunt features an 8.5-mm tube with an outer diameter of 350 µm and a 70-µm diameter lumen. Implantation creates a subconjunctival bleb and lowers intraocular pressure by increasing aqueous humor outflow.
Active Comparator: Trabeculectomy Patients will be treated with trabeculectomy.	Other: Trabeculectomy; Trabeculectomy is the most commonly performed surgical procedure and is considered the gold standard.

Outcome Measures

Primary Outcome Measures

1. Difference in intraocular pressure [1 year]

   The primary endpoint is the difference between intraocular pressure after microshunt implantation vs trabeculectomy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University Innsbruck	Innsbruck	Tyrol	Austria	6020

Sponsors and Collaborators

• Medical University Innsbruck

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University Innsbruck
• ClinicalTrials.gov Identifier: NCT04440527
• Other Study ID Numbers: PAINT-Study
• First Posted: Jun 19, 2020
• Last Update Posted: Jun 19, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Exfoliation Syndrome

Study Results

No Results Posted as of Jun 19, 2020