Who is sponsoring NCT03931564?

NCT03931564 is sponsored by Maastricht University Medical Center.

What drugs are being tested in NCT03931564?

Interventions in NCT03931564: PRESERFLO Microshunt implantation, Trabeculectomy.

What condition does NCT03931564 study?

NCT03931564 studies Primary Open-angle Glaucoma.

Is NCT03931564 still recruiting?

NCT03931564 is currently status unknown. Last updated 19 March 2024.

Last reviewed 2024-03-19 · How we verify

NCT03931564: SIGHT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

SIGHT Study: Cost-effectiveness of InnFocus Microshunt Implantation vs. Trabeculectomy.

Status unknown NA Last updated 19 March 2024

What this trial tests

NA trial testing PRESERFLO Microshunt implantation in Primary Open-angle Glaucoma in 124 participants. Status unknown.

Timeline

1 February 2020

Primary endpoint
1 December 2024

1 December 2024

Quick facts

Lead sponsor	Maastricht University Medical Center
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	124
Start date	1 February 2020
Primary completion	1 December 2024
Estimated completion	1 December 2024
Sites	1 location across Netherlands

Drugs / interventions tested

PRESERFLO Microshunt implantation
Trabeculectomy

Conditions studied

Primary Open-angle Glaucoma — all drugs for Primary Open-angle Glaucoma →

Sponsor

Maastricht University Medical Center

Who can join

Adults 18 to 80, any sex, with Primary Open-angle Glaucoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The standard surgical treatment for glaucoma is trabeculectomy. The PRESERFLO™ (formerly InnFocus) Microshunt (IMS) is a new, minimally invasive drainage device which has been suggested to result in similar IOP lowering, but with faster visual recovery and less complications and postoperative interventions. The objective of this study is to aid in deciding on the use of the IMS in glaucoma surgery by assessing its efficacy and cost-effectiveness in patients with primary open angle glaucoma (POAG) compared to the standard trabeculectomy (TE).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

PreserFlo<sup>®</sup> MicroShunt: An Overview of This Minimally Invasive Device for Open-Angle Glaucoma.
Gambini G, Carlà MM, Giannuzzi F, Caporossi T, et al · · 2022 · cited 46× · PMID 35225971 · DOI 10.3390/vision6010012
Effectiveness and cost-effectiveness of MicroShunt implantation versus standard trabeculectomy for open-angle glaucoma (a SIGHT study): study protocol of a multicentre randomised controlled trial.
Scheres LMJ, van den Biggelaar FJHM, Winkens B, Kujovic-Aleksov S, et al · · 2023 · cited 8× · PMID 36721130 · DOI 10.1186/s12886-022-02734-y
Characteristics and publication status of minimally invasive glaucoma surgery trials registered in ClinicalTrials.gov, 2007-2024: a cross-sectional study.
Peng C, Jia H, Hu J, Jiao Y. · · 2025 · PMID 39855651 · DOI 10.1136/bmjopen-2024-095854

Verify or expand the search:

Other recruiting trials for Primary Open-angle Glaucoma

Currently open trials in the same condition.

NCT06692205 — Effects of Primary Open-angle Glaucoma on Visual-motor Coordination · recruiting
NCT03921931 — Retinal Photoreceptor Outer Segment Length Before and After Light Stimulation - a Pilot Study · NA · recruiting
NCT03673644 — Impact of Glaucoma and Visual Field Loss on Life Space · active not recruiting

Other Maastricht University Medical Center trials

Trials by the same sponsor.

NCT04603261 — Time to Excretion of Contrast, a Maastricht Prospective Observational Study · withdrawn
NCT04598516 — Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30 · withdrawn
NCT04597892 — Efficacy of Point-Of-Care Creatinine Assays in Patients With eGFR <30 Receiving Intravascular Contrast · withdrawn
NCT07287358 — Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II · NA · not yet recruiting
NCT07501780 — Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03931564 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Maastricht University Medical Center
Last refreshed: 19 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03931564.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing