NorMIGS - a Study of Micro-invasive Glaucoma Surgery

NCT05340647 | Recruiting

• 1 other identifier: 415116
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure

  Measured by tonometry

  8 weeks after surgery

Secondary Outcomes (18)

• Intraocular pressure

  6 months after surgery

• Intraocular pressure

  2 years after surgery

• Intraocular pressure

  5 years after surgery

• Visual outcome

  8 weeks after surgery

• Visual outcome

  6 months after surgery

Study Arms (3)

Group 1 Preserflo microshunt

Procedure: Preserflo microshunt

Group 2 Trabeculectomy

Procedure: Trabeculectomy

Group 3 Other MIGS

Other micro-invasive glaucoma surgery (MIGS) than Preserflo microshunt (e.g., Xen gel stent, iStent inject)

Procedure: Other MIGS

Interventions

Preserflo microshunt PROCEDURE

Implantation of Preserflo microshunt (Santen) to lower intraocular pressure

Group 1 Preserflo microshunt

Trabeculectomy PROCEDURE

Trabeculectomy surgery to lower intraocular pressure

Group 2 Trabeculectomy

Other MIGS PROCEDURE

Other MIGS than Preserflo microshunt (e.g., XEN gel stent, iStent inject) to lower intraocular pressure

Group 3 Other MIGS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• \- High intraocular pressure due to increased episcleral venous pressure, hemorrhagic glaucoma, traumatic glaucoma or uveitis glaucoma

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Department of Ophthalmology, Oslo University Hospital

Oslo, 1163, Norway

RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Olav Kristianslund, MD PhD

  Department of Ophthalmology, Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olav Kristianslund, MD PhD

CONTACT

+4722118545; olakri@ous-hf.no

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Head of section / Senior consultant MD PhD

Study Record Dates

• First Submitted: April 9, 2022
• First Posted: April 22, 2022
• Study Start: April 22, 2022
• Primary Completion: December 1, 2023
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

NO (1)