Clincosm LogoSign in Get a demo

NorMIGS - a Study of Micro-invasive Glaucoma Surgery

Sponsor
Oslo University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05340647
Collaborator
(none)
100
Enrollment
1
Location
73.3
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Preserflo microshunt
  • Procedure: Trabeculectomy
  • Procedure: Other MIGS

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
NorMIGS - a Prospective Study of Micro-invasive Glaucoma Surgery
Anticipated Study Start Date :
Apr 22, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jun 1, 2028

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Intraocular pressure [8 weeks after surgery]

    Measured by tonometry

Secondary Outcome Measures

  1. Intraocular pressure [6 months after surgery]

    Measured by tonometry

  2. Intraocular pressure [2 years after surgery]

    Measured by tonometry

  3. Intraocular pressure [5 years after surgery]

    Measured by tonometry

  4. Visual outcome [8 weeks after surgery]

    Measure uncorrected and corrected distance visual acuity using visual acuity chart

  5. Visual outcome [6 months after surgery]

    Measure uncorrected and corrected distance visual acuity using visual acuity chart

  6. Visual outcome [2 years after surgery]

    Measure uncorrected and corrected distance visual acuity using visual acuity chart

  7. Visual outcome [5 years after surgery]

    Measure uncorrected and corrected distance visual acuity using visual acuity chart

  8. Intraocular inflammation [4 weeks after surgery]

    Measured by laser flare meter

  9. Intraocular inflammation [6 months after surgery]

    Measured by laser flare meter

  10. Central macular thickness (CMT) [4 weeks after surgery]

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

  11. Central macular thickness (CMT) [6 months after surgery]

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

  12. Corneal endothelial cell density [6 months after surgery]

    Measured by confocal or spectral microscopy

  13. Corneal endothelial cell density [2 years after surgery]

    Measured by confocal or spectral microscopy

  14. Corneal endothelial cell density [5 years after surgery]

    Measured by confocal or spectral microscopy

  15. Patient reported outcome measure (PROMs) [6 months after surgery]

    EuroQol-5 D (EQ-5D) questionnaire

  16. Patient reported outcome measure (PROMs) [2 years after surgery]

    EuroQol-5 D (EQ-5D) questionnaire

  17. Patient reported outcome measure (PROMs) [6 months after surgery]

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

  18. Patient reported outcome measure (PROMs) [2 years after surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Ophthalmology, Oslo University Hospital Oslo Norway 1163

Sponsors and Collaborators

  • Oslo University Hospital

Investigators

  • Principal Investigator: Olav Kristianslund, MD PhD, Department of Ophthalmology, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Olav Kristianslund, Principal investigator, Head of section / Senior consultant MD PhD, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT05340647
Other Study ID Numbers:
  • 415116
First Posted:
Apr 22, 2022
Last Update Posted:
Apr 28, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Glaucoma

Study Results

No Results Posted as of Apr 28, 2022