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Recruiting NCT05340647

NorMIGS - a Study of Micro-invasive Glaucoma Surgery

— Observational Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Preserflo microshunt, Trabeculectomy, Other MIGS.
Who it may be relevant to
Registry conditions: Glaucoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

NorMIGS - a Prospective Study of Micro-invasive Glaucoma Surgery

Overview

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.

Interventions

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

Primary outcome measures

  • Intraocular pressure [Time frame: 8 weeks after surgery]
Secondary outcome measures (12)
  • Intraocular pressure [Time frame: 6 months after surgery]
  • Intraocular pressure [Time frame: 2 years after surgery]
  • Intraocular pressure [Time frame: 5 years after surgery]
  • Visual outcome [Time frame: 8 weeks after surgery]
  • Visual outcome [Time frame: 6 months after surgery]
  • Visual outcome [Time frame: 2 years after surgery]
  • Visual outcome [Time frame: 5 years after surgery]
  • Intraocular inflammation [Time frame: 4 weeks after surgery]
  • Intraocular inflammation [Time frame: 6 months after surgery]
  • Central macular thickness (CMT) [Time frame: 4 weeks after surgery]
  • Central macular thickness (CMT) [Time frame: 6 months after surgery]
  • Corneal endothelial cell density [Time frame: 6 months after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Norway · 1 center
  • Department of Ophthalmology, Oslo University Hospital — Oslo

Identifiers

NCT: NCT05340647 · 415116

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗