NorMIGS - a Study of Micro-invasive Glaucoma Surgery (NorMIGS)

November 26, 2022 updated by: Olav Kristianslund, Oslo University Hospital

NorMIGS - a Prospective Study of Micro-invasive Glaucoma Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 1163
        • Recruiting
        • Department of Ophthalmology, Oslo University Hospital
        • Contact:
          • Olav Kristianslund

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from patients referred to the Department of Ophthalmology, Oslo University Hospital, for glaucoma surgery. The operation type will be decided by clinicians regardless of study participation, and they will be assigned to study groups based on this clinical decisions (non-interventional). In addition, the type of glaucoma will be determined, which is relevant for sub group analyses (pseudoexfoliation groucoma (PEXG), primary open-angle glaucoma (POAG) and other types).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1 Preserflo microshunt
Procedure: Preserflo microshunt
Implantation of Preserflo microshunt (Santen) to lower intraocular pressure
Group 2 Trabeculectomy
Procedure: Trabeculectomy
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)
Procedure: Other MIGS
Other MIGS than Preserflo microshunt (e.g., XEN gel stent, iStent inject) to lower intraocular pressure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intraocular pressure
Time Frame: 8 weeks after surgery
Measured by tonometry
8 weeks after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intraocular pressure
Time Frame: 6 months after surgery
Measured by tonometry
6 months after surgery
Intraocular pressure
Time Frame: 2 years after surgery
Measured by tonometry
2 years after surgery
Intraocular pressure
Time Frame: 5 years after surgery
Measured by tonometry
5 years after surgery
Visual outcome
Time Frame: 8 weeks after surgery
Measure uncorrected and corrected distance visual acuity using visual acuity chart
8 weeks after surgery
Visual outcome
Time Frame: 6 months after surgery
Measure uncorrected and corrected distance visual acuity using visual acuity chart
6 months after surgery
Visual outcome
Time Frame: 2 years after surgery
Measure uncorrected and corrected distance visual acuity using visual acuity chart
2 years after surgery
Visual outcome
Time Frame: 5 years after surgery
Measure uncorrected and corrected distance visual acuity using visual acuity chart
5 years after surgery
Intraocular inflammation
Time Frame: 4 weeks after surgery
Measured by laser flare meter
4 weeks after surgery
Intraocular inflammation
Time Frame: 6 months after surgery
Measured by laser flare meter
6 months after surgery
Central macular thickness (CMT)
Time Frame: 4 weeks after surgery
Measure CMT (in um) on optical coherence tomography (OCT)
4 weeks after surgery
Central macular thickness (CMT)
Time Frame: 6 months after surgery
Measure CMT (in um) on optical coherence tomography (OCT)
6 months after surgery
Corneal endothelial cell density
Time Frame: 6 months after surgery
Measured by confocal or spectral microscopy
6 months after surgery
Corneal endothelial cell density
Time Frame: 2 years after surgery
Measured by confocal or spectral microscopy
2 years after surgery
Corneal endothelial cell density
Time Frame: 5 years after surgery
Measured by confocal or spectral microscopy
5 years after surgery
Patient reported outcome measure (PROMs)
Time Frame: 6 months after surgery
EuroQol-5 D (EQ-5D) questionnaire
6 months after surgery
Patient reported outcome measure (PROMs)
Time Frame: 2 years after surgery
EuroQol-5 D (EQ-5D) questionnaire
2 years after surgery
Patient reported outcome measure (PROMs)
Time Frame: 6 months after surgery
National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ 25)
6 months after surgery
Patient reported outcome measure (PROMs)
Time Frame: 2 years after surgery
National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ 25)
2 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 415116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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