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

NCT03931564 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-03-19

No results posted yet for this study

Summary

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).

Conditions

  • Primary Open-angle Glaucoma

Interventions

PROCEDURE

PRESERFLO Microshunt implantation

The intervention consists of the microshunt implantation augmented with mitomycin C application.

PROCEDURE

Trabeculectomy

The usual care / control group will undergo a standard fornix based trabeculectomy augmented with mitomycin C application.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Henny Beckers, MD, PhD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03931564 on ClinicalTrials.gov