GlaucomaNorMIGSNCT05340647
NorMIGS - a Study of Micro-invasive Glaucoma Surgery
An observational study of Glaucoma, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Preserflo microshunt, Trabeculectomy and Other MIGS
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 22 Apr 2022to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- High intraocular pressure due to increased episcleral venous pressure, hemorrhagic glaucoma, traumatic glaucoma or uveitis glaucoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Oslo University Hospital
Oslo, 1163
Olav Kristianslund
About this study
Official title: 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.
- Conditions
- Glaucoma
- Being tested
- Preserflo microshunt, Trabeculectomy, Other MIGS
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preserflo microshuntProcedure or surgery
Implantation of Preserflo microshunt (Santen) to lower intraocular pressure
TrabeculectomyProcedure or surgery
Trabeculectomy surgery to lower intraocular pressure
Other MIGSProcedure or surgery
Other MIGS than Preserflo microshunt (e.g., XEN gel stent, iStent inject) to lower intraocular pressure
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Preserflo microshunt | Not described Receives: Procedure: Preserflo microshunt | |
| Group 2 Trabeculectomy | Not described Receives: Procedure: Trabeculectomy | |
| Group 3 Other MIGS | Other micro-invasive glaucoma surgery (MIGS) than Preserflo microshunt (e.g., Xen gel stent, iStent inject) Receives: Procedure: Other MIGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Measured by tonometry
Measured: 8 weeks after surgery
Secondary outcomes (18)
Intraocular pressure
Measured by tonometry
Measured: 6 months after surgery
Intraocular pressure
Measured by tonometry
Measured: 2 years after surgery
Intraocular pressure
Measured by tonometry
Measured: 5 years after surgery
Visual outcome
Measure uncorrected and corrected distance visual acuity using visual acuity chart
Measured: 8 weeks after surgery
Visual outcome
Measure uncorrected and corrected distance visual acuity using visual acuity chart
Measured: 6 months after surgery
Visual outcome
Measure uncorrected and corrected distance visual acuity using visual acuity chart
Measured: 2 years after surgery
Visual outcome
Measure uncorrected and corrected distance visual acuity using visual acuity chart
Measured: 5 years after surgery
Intraocular inflammation
Measured by laser flare meter
Measured: 4 weeks after surgery
Intraocular inflammation
Measured by laser flare meter
Measured: 6 months after surgery
Central macular thickness (CMT)
Measure CMT (in um) on optical coherence tomography (OCT)
Measured: 4 weeks after surgery
Central macular thickness (CMT)
Measure CMT (in um) on optical coherence tomography (OCT)
Measured: 6 months after surgery
Corneal endothelial cell density
Measured by confocal or spectral microscopy
Measured: 6 months after surgery
Corneal endothelial cell density
Measured by confocal or spectral microscopy
Measured: 2 years after surgery
Corneal endothelial cell density
Measured by confocal or spectral microscopy
Measured: 5 years after surgery
Patient reported outcome measure (PROMs)
EuroQol-5 D (EQ-5D) questionnaire
Measured: 6 months after surgery
Patient reported outcome measure (PROMs)
EuroQol-5 D (EQ-5D) questionnaire
Measured: 2 years after surgery
Patient reported outcome measure (PROMs)
National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ 25)
Measured: 6 months after surgery
Patient reported outcome measure (PROMs)
National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ 25)
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start22 Apr 2022
- Primary completionDec 2023 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olav Kristianslund, Oslo University Hospital
- Investigators
- Olav Kristianslund, MD PhD, Principal investigator, Department of Ophthalmology, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340647
- Sponsor's protocol ID
- 415116
- Acronym
- NorMIGS
- Status last verified
- Nov 2022
- First submitted
- 9 Apr 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NorMIGS - a Prospective Study of Micro-invasive Glaucoma Surgery
- ClinicalTrials.gov ID
- NCT05340647
- Acronym / sponsor ID
- NorMIGS / 415116
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 Preserflo microshunt | – | Procedure: Preserflo microshunt |
| Group 2 Trabeculectomy | – | Procedure: Trabeculectomy |
| Group 3 Other MIGS | – | Procedure: Other MIGSOther micro-invasive glaucoma surgery (MIGS) than Preserflo microshunt (e.g., Xen gel stent, iStent inject) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- High intraocular pressure due to increased episcleral venous pressure, hemorrhagic glaucoma, traumatic glaucoma or uveitis glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preserflo microshuntImplantation of Preserflo microshunt (Santen) to lower intraocular pressure | Procedure or surgery | Group 1 Preserflo microshunt |
| TrabeculectomyTrabeculectomy surgery to lower intraocular pressure | Procedure or surgery | Group 2 Trabeculectomy |
| Other MIGSOther MIGS than Preserflo microshunt (e.g., XEN gel stent, iStent inject) to lower intraocular pressure | Procedure or surgery | Group 3 Other MIGS |
Primary outcome
Intraocular pressure
Time frame: 8 weeks after surgery
Measured by tonometry
18 secondary outcomes
Intraocular pressure
Time frame: 6 months after surgery
Intraocular pressure
Time frame: 2 years after surgery
Intraocular pressure
Time frame: 5 years after surgery
Visual outcome
Time frame: 8 weeks after surgery
Visual outcome
Time frame: 6 months after surgery
Visual outcome
Time frame: 2 years after surgery
Visual outcome
Time frame: 5 years after surgery
Intraocular inflammation
Time frame: 4 weeks after surgery
Intraocular inflammation
Time frame: 6 months after surgery
Central macular thickness (CMT)
Time frame: 4 weeks after surgery
Central macular thickness (CMT)
Time frame: 6 months after surgery
Corneal endothelial cell density
Time frame: 6 months after surgery
Corneal endothelial cell density
Time frame: 2 years after surgery
Corneal endothelial cell density
Time frame: 5 years after surgery
Patient reported outcome measure (PROMs)
Time frame: 6 months after surgery
Patient reported outcome measure (PROMs)
Time frame: 2 years after surgery
Patient reported outcome measure (PROMs)
Time frame: 6 months after surgery
Patient reported outcome measure (PROMs)
Time frame: 2 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olav Kristianslund, MD PhD principal investigator
Department of Ophthalmology, Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olav Kristianslund, MD PhD (+4722118545, olakri@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (time frame: 8 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.