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NCT Number: NCT05340647

NorMIGS - a 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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, Oslo University Hospital

Oslo, 1163, Norway

Location status: Recruiting

Location contact

Olav Kristianslund

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preserflo microshunt

Procedure

Implantation of Preserflo microshunt (Santen) to lower intraocular pressure

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

Primary outcomes

  1. Intraocular pressure

    Time frame: 8 weeks after surgery

    Measured by tonometry

Secondary outcomes

  1. Intraocular pressure

    Time frame: 6 months after surgery

    Measured by tonometry

  2. Intraocular pressure

    Time frame: 2 years after surgery

    Measured by tonometry

  3. Intraocular pressure

    Time frame: 5 years after surgery

    Measured by tonometry

  4. Visual outcome

    Time frame: 8 weeks after surgery

    Measure uncorrected and corrected distance visual acuity using visual acuity chart

  5. Visual outcome

    Time frame: 6 months after surgery

    Measure uncorrected and corrected distance visual acuity using visual acuity chart

  6. Visual outcome

    Time frame: 2 years after surgery

    Measure uncorrected and corrected distance visual acuity using visual acuity chart

  7. Visual outcome

    Time frame: 5 years after surgery

    Measure uncorrected and corrected distance visual acuity using visual acuity chart

  8. Intraocular inflammation

    Time frame: 4 weeks after surgery

    Measured by laser flare meter

  9. Intraocular inflammation

    Time frame: 6 months after surgery

    Measured by laser flare meter

  10. Central macular thickness (CMT)

    Time frame: 4 weeks after surgery

    Measure CMT (in um) on optical coherence tomography (OCT)

  11. Central macular thickness (CMT)

    Time frame: 6 months after surgery

    Measure CMT (in um) on optical coherence tomography (OCT)

  12. Corneal endothelial cell density

    Time frame: 6 months after surgery

    Measured by confocal or spectral microscopy

  13. Corneal endothelial cell density

    Time frame: 2 years after surgery

    Measured by confocal or spectral microscopy

  14. Corneal endothelial cell density

    Time frame: 5 years after surgery

    Measured by confocal or spectral microscopy

  15. Patient reported outcome measure (PROMs)

    Time frame: 6 months after surgery

    EuroQol-5 D (EQ-5D) questionnaire

  16. Patient reported outcome measure (PROMs)

    Time frame: 2 years after surgery

    EuroQol-5 D (EQ-5D) questionnaire

  17. Patient reported outcome measure (PROMs)

    Time frame: 6 months after surgery

    National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ 25)

  18. Patient reported outcome measure (PROMs)

    Time frame: 2 years after surgery

    National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ 25)

Study contacts

Contact information is provided by the study sponsor or research team.

Olav Kristianslund, MD PhD

CONTACT

[email protected]

+4722118545

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

NorMIGS - a Prospective Study of Micro-invasive Glaucoma Surgery

Acronym: NorMIGS

Important dates

Study start
2022
Primary completion
2023
Study completion
2028
First posted
Apr 22, 2022
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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