Clinical trial NCT05340647: NorMIGS - a Study of Micro-invasive Glaucoma Surgery
Official title: NorMIGS - a Prospective Study of Micro-invasive Glaucoma Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glaucoma
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Intraocular pressure
timeFrame: 8 weeks after surgery
Secondary outcomes:
measure: Intraocular pressure
timeFrame: 6 months after surgery
measure: Intraocular pressure
timeFrame: 2 years after surgery
measure: Intraocular pressure
timeFrame: 5 years after surgery
measure: Visual outcome
timeFrame: 8 weeks after surgery
measure: Visual outcome
timeFrame: 6 months after surgery
measure: Visual outcome
timeFrame: 2 years after surgery
measure: Visual outcome
timeFrame: 5 years after surgery
measure: Intraocular inflammation
timeFrame: 4 weeks after surgery
measure: Intraocular inflammation
timeFrame: 6 months after surgery
measure: Central macular thickness (CMT)
timeFrame: 4 weeks after surgery
measure: Central macular thickness (CMT)
timeFrame: 6 months after surgery
measure: Corneal endothelial cell density
timeFrame: 6 months after surgery
measure: Corneal endothelial cell density
timeFrame: 2 years after surgery
measure: Corneal endothelial cell density
timeFrame: 5 years after surgery
measure: Patient reported outcome measure (PROMs)
timeFrame: 6 months after surgery
measure: Patient reported outcome measure (PROMs)
timeFrame: 2 years after surgery
measure: Patient reported outcome measure (PROMs)
timeFrame: 6 months after surgery
measure: Patient reported outcome measure (PROMs)
timeFrame: 2 years after surgery
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Ophthalmology, Oslo University Hospital
Study officials:
affiliation: Department of Ophthalmology, Oslo University Hospital
name: Olav Kristianslund, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: