Glaucoma
Conditions
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.
Interventions
PROCEDUREPreserflo microshunt
Implantation of Preserflo microshunt (Santen) to lower intraocular pressure
PROCEDURETrabeculectomy
Trabeculectomy surgery to lower intraocular pressure
PROCEDUREOther MIGS
Other MIGS than Preserflo microshunt (e.g., XEN gel stent, iStent inject) to lower intraocular pressure
Sponsors
Oslo University Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure | 8 weeks after surgery | Measured by tonometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure | 6 months after surgery | Measured by tonometry |
| Visual outcome | 8 weeks after surgery | Measure uncorrected and corrected distance visual acuity using visual acuity chart |
| Patient reported outcome measure (PROMs) | 6 months after surgery | EuroQol-5 D (EQ-5D) questionnaire |
| Central macular thickness (CMT) | 4 weeks after surgery | Measure CMT (in um) on optical coherence tomography (OCT) |
| Corneal endothelial cell density | 6 months after surgery | Measured by confocal or spectral microscopy |
| Intraocular inflammation | 4 weeks after surgery | Measured by laser flare meter |
Countries
Norway
Contacts
Primary ContactOlav Kristianslund, MD PhD
Outcome results
None listed