NorMIGS - a Study of Micro-invasive Glaucoma Surgery

NCT ID: NCT05340647

Last Updated: 2022-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-22

Study Completion Date

2028-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

NorMIGS is a non-randomized clinical study of intraocular pressure lowering effect and complications after Preserflo microshunt implantation versus other types of glaucoma surgery. The study is conducted in the Department of Ophthalmology, Oslo University Hospital, Norway.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1 Preserflo microshunt

Preserflo microshunt

Intervention Type PROCEDURE

Implantation of Preserflo microshunt (Santen) to lower intraocular pressure

Group 2 Trabeculectomy

Trabeculectomy

Intervention Type PROCEDURE

Trabeculectomy surgery to lower intraocular pressure

Group 3 Other MIGS

Other micro-invasive glaucoma surgery (MIGS) than Preserflo microshunt (e.g., Xen gel stent, iStent inject)

Other MIGS

Intervention Type PROCEDURE

Other MIGS than Preserflo microshunt (e.g., XEN gel stent, iStent inject) to lower intraocular pressure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Preserflo microshunt

Implantation of Preserflo microshunt (Santen) to lower intraocular pressure

Intervention Type PROCEDURE

Trabeculectomy

Trabeculectomy surgery to lower intraocular pressure

Intervention Type PROCEDURE

Other MIGS

Other MIGS than Preserflo microshunt (e.g., XEN gel stent, iStent inject) to lower intraocular pressure

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients must be 18 years or older at the time of signing the informed consent form. There is no upper age limit.
* Scheduled for implantation of Preserflo microshunt, trabeculectomy or other types of MIGS
* Ability to cooperate fairly well during the examinations
* Willing to participate in the study and capable of providing informed consent

Exclusion Criteria

\- High intraocular pressure due to increased episcleral venous pressure, hemorrhagic glaucoma, traumatic glaucoma or uveitis glaucoma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Olav Kristianslund

Principal investigator, Head of section / Senior consultant MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Olav Kristianslund, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Oslo University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Ophthalmology, Oslo University Hospital

Oslo, , Norway

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Norway

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Olav Kristianslund, MD PhD

Role: CONTACT

+4722118545

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Olav Kristianslund

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

415116

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.