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Trial · NCT05707442

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPerimetric Mean Deviation (PMD)6 monthsThe change in perimetric mean deviation (PMD) from baseline to 6 month in the eye with the most severe visual loss at baseline.
SecondaryCerebrospinal Fluid (CSF) Opening Pressure6 monthsThe change in intracranial pressure measured by lumbar puncture opening pressure from baseline to 6 months.
SecondaryPapilledema Grade: Frisén grade(0-5 scores,and higher scores mean worse outcome)6 monthsThe change in papilledema measured by Frisén grade from baseline to 6 months
SecondaryRetinal Nerve Fiber Layer Thickness6 monthsThe change in thickness of retinal nerve fiber layer measured by optical coherence tomography (OCT) from baseline to 6 months.
SecondaryTotal Retinal Thickness6 monthsThe change in thickness of total retina measured by optical coherence tomography (OCT) from baseline to 6 months.
SecondaryVisual Acuity: National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25, minimum and maximum values: 0-100 points, higher scores mean a better visual function)6 monthsThe change in vision measured by National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) from baseline to 6 months.
Secondary
Visual Acuity: 10-item neuro-ophthalmic supplement to the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) (minimum and maximum values: 0-100 points, higher scores mean a better visual function)
6 monthsThe change in vision measured by 10-item neuro-ophthalmic supplement to the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25)from baseline to 6 months.
SecondaryHeadache: Headache Impact Test-6 (HIT-6, minimum and maximum values: 36-78 points, higher scores mean greater headache severity)6 monthsThe change in headache measured by Headache Impact Test-6 (HIT-6) questionnaire from baseline to 6 months.
SecondaryPulsatile tinnitus: Tinnitus Handicap Inventory (THI, minimum and maximum values: 0-100 points, higher scores mean more serious tinnitus disability)6 months
The change in pulsatile tinnitus from baseline to 6 months;pulsatile tinnitus was assessed using the Tinnitus Handicap Inventory (THI), which is a self-report measure that can be used in a busy clinical practice to quantify the impact of tinnitus on daily living.
OtherFunctional health status and quality of life:EuroQol five dimensions questionnaire (EQ-5D,0-100,higher scores mean a better outcome)6 monthsThe change in functional health status and quality of life measured by EuroQol five dimensions questionnaire (EQ-5D) from baseline to 6 months
OtherCost-effectiveness analysis (mean costs per patient)6 monthsThe indicator of cost-effectiveness analysis refers to the mean costs per patient.
OtherCost-effectiveness analysis (quality-adjusted life years)6 monthsThe indicator of cost-effectiveness analysis refers to the quality-adjusted life years.
OtherCost-effectiveness analysis (the cost saving per extra patient with a good outcome)6 monthsThe indicator of cost-effectiveness analysis refers to the cost saving per extra patient with a good outcome.
OtherCost-effectiveness analysis (the cost saving per additional quality-adjusted life year)6 monthsThe indicator of cost-effectiveness analysis refers to the cost saving per additional quality-adjusted life year.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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