NorMIGS - a Study of Micro-invasive Glaucoma Surgery

Study Overview
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Brief Summary
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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.

Official Title
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NorMIGS - a Prospective Study of Micro-invasive Glaucoma Surgery

Conditions
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Glaucoma

Intervention / Treatment
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* Procedure: Preserflo microshunt
* Procedure: Trabeculectomy
* Procedure: Other MIGS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 Preserflo microshunt<br> | Procedure: Preserflo microshunt<br>* Implantation of Preserflo microshunt (Santen) to lower intraocular pressure<br>|
| Group 2 Trabeculectomy<br> | Procedure: Trabeculectomy<br>* Trabeculectomy surgery to lower intraocular pressure<br>|
| Group 3 Other MIGS<br>Other micro-invasive glaucoma surgery (MIGS) than Preserflo microshunt (e.g., Xen gel stent, iStent inject) | Procedure: Other MIGS<br>* Other MIGS than Preserflo microshunt (e.g., XEN gel stent, iStent inject) to lower intraocular pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure | Measured by tonometry | 8 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure | Measured by tonometry | 6 months after surgery | 
| Intraocular pressure | Measured by tonometry | 2 years after surgery | 
| Intraocular pressure | Measured by tonometry | 5 years after surgery | 
| Visual outcome | Measure uncorrected and corrected distance visual acuity using visual acuity chart | 8 weeks after surgery | 
| Visual outcome | Measure uncorrected and corrected distance visual acuity using visual acuity chart | 6 months after surgery | 
| Visual outcome | Measure uncorrected and corrected distance visual acuity using visual acuity chart | 2 years after surgery | 
| Visual outcome | Measure uncorrected and corrected distance visual acuity using visual acuity chart | 5 years after surgery | 
| Intraocular inflammation | Measured by laser flare meter | 4 weeks after surgery | 
| Intraocular inflammation | Measured by laser flare meter | 6 months after surgery | 
| Central macular thickness (CMT) | Measure CMT (in um) on optical coherence tomography (OCT) | 4 weeks after surgery | 
| Central macular thickness (CMT) | Measure CMT (in um) on optical coherence tomography (OCT) | 6 months after surgery | 
| Corneal endothelial cell density | Measured by confocal or spectral microscopy | 6 months after surgery | 
| Corneal endothelial cell density | Measured by confocal or spectral microscopy | 2 years after surgery | 
| Corneal endothelial cell density | Measured by confocal or spectral microscopy | 5 years after surgery | 
| Patient reported outcome measure (PROMs) | EuroQol-5 D (EQ-5D) questionnaire | 6 months after surgery | 
| Patient reported outcome measure (PROMs) | EuroQol-5 D (EQ-5D) questionnaire | 2 years after surgery | 
| Patient reported outcome measure (PROMs) | National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ 25) | 6 months after surgery | 
| Patient reported outcome measure (PROMs) | National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ 25) | 2 years after surgery |