NorMIGS - a Study of Micro-invasive Glaucoma Surgery (NorMIGS)

NorMIGS - a Prospective Study of Micro-invasive Glaucoma Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Procedure: Preserflo microshunt; Procedure: Trabeculectomy; Procedure: Other MIGS

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 1163
    • Recruiting
    • Department of Ophthalmology, Oslo University Hospital
    • Contact: Olav Kristianslund

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 22, 2022
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): June 1, 2028

Study Registration Dates

• First Submitted: April 9, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (ACTUAL): April 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 26, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 415116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No