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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Preserflo microshunt |
| ||
| Group 2 Trabeculectomy |
| ||
| Group 3 Other MIGS | Other micro-invasive glaucoma surgery (MIGS) than Preserflo microshunt (e.g., Xen gel stent, iStent inject) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preserflo microshunt | Procedure | Implantation of Preserflo microshunt (Santen) to lower intraocular pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure | Measured by tonometry | 8 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure | Measured by tonometry | 6 months after surgery |
| Intraocular pressure | Measured by tonometry | 2 years after surgery |
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Inclusion Criteria:
Exclusion Criteria:
- High intraocular pressure due to increased episcleral venous pressure, hemorrhagic glaucoma, traumatic glaucoma or uveitis glaucoma
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olav Kristianslund, MD PhD | Contact | +4722118545 | olakri@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Olav Kristianslund, MD PhD | Department of Ophthalmology, Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Oslo University Hospital | Recruiting | Oslo | 1163 | Norway |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Trabeculectomy | Procedure | Trabeculectomy surgery to lower intraocular pressure |
|
| Other MIGS | Procedure | Other MIGS than Preserflo microshunt (e.g., XEN gel stent, iStent inject) to lower intraocular pressure |
|
| 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 |