NorMIGS - a Study of Micro-invasive Glaucoma Surgery

Glaucoma Clinical Trial

— NorMIGS  

Official title:

NorMIGS - a Prospective Study of Micro-invasive Glaucoma Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05340647
• Other study ID #: 415116
• Status: Recruiting
• Start date: April 22, 2022
• Est. completion date: June 2028

Study information

• Verified date: November 2022
• Source: Oslo University Hospital
• Contact: Olav Kristianslund, MD PhD
• Phone: +4722118545
• Email: olakri[@]ous-hf.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2028
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• Preserflo microshunt
Implantation of Preserflo microshunt (Santen) to lower intraocular pressure
• Trabeculectomy
Trabeculectomy surgery to lower intraocular pressure
• Other MIGS
Other MIGS than Preserflo microshunt (e.g., XEN gel stent, iStent inject) to lower intraocular pressure

Locations

Country	Name	City	State
Norway	Department of Ophthalmology, Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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