NorMIGS - a Study of Micro-invasive Glaucoma Surgery
ID: NCT05340647
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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.
Implantation of Preserflo microshunt (Santen) to lower intraocular pressure
Trabeculectomy surgery to lower intraocular pressure
Other MIGS than Preserflo microshunt (e.g., XEN gel stent, iStent inject) to lower intraocular pressure
Treatment Arms Description
Other micro-invasive glaucoma surgery (MIGS) than Preserflo microshunt (e.g., Xen gel stent, iStent inject)
- 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
- \- High intraocular pressure due to increased episcleral venous pressure, hemorrhagic glaucoma, traumatic glaucoma or uveitis glaucoma
Primary Outcome Measures
- Intraocular pressure — Time Frame: 8 weeks after surgery
Measured by tonometry
View Secondary Outcome Measures (18)
- Intraocular pressure — Time Frame: 6 months after surgery
Measured by tonometry
- Intraocular pressure — Time Frame: 2 years after surgery
Measured by tonometry
- Intraocular pressure — Time Frame: 5 years after surgery
Measured by tonometry
- Visual outcome — Time Frame: 8 weeks after surgery
Measure uncorrected and corrected distance visual acuity using visual acuity chart
- Visual outcome — Time Frame: 6 months after surgery
Measure uncorrected and corrected distance visual acuity using visual acuity chart
- Visual outcome — Time Frame: 2 years after surgery
Measure uncorrected and corrected distance visual acuity using visual acuity chart
- Visual outcome — Time Frame: 5 years after surgery
Measure uncorrected and corrected distance visual acuity using visual acuity chart
- Intraocular inflammation — Time Frame: 4 weeks after surgery
Measured by laser flare meter
- Intraocular inflammation — Time Frame: 6 months after surgery
Measured by laser flare meter
- Central macular thickness (CMT) — Time Frame: 4 weeks after surgery
Measure CMT (in um) on optical coherence tomography (OCT)
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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View Official Medical/Scientific Title
NorMIGS - a Prospective Study of Micro-invasive Glaucoma Surgery