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Trial record 42 of 1614 for:    glaucoma

Visual Field Defect Estimation Using Sequentially Optimized Reconstruction Strategy on Healthy and Glaucoma Subjects

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ClinicalTrials.gov Identifier: NCT03325751
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
University of Bern
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

Perimetry is a well-established method that is used to measure the visual field functions of humans. Commercially available products, such as the OCTOPUS 900 (Haag-Streit AG, Koeniz, Switzerland), are commonly used for assessing the visual field. Such devices are of critical value for patients suffering of glaucoma and neuro-ophthalmic conditions. The operating principle is to sequentially present light stimuli of different intensity at different locations within the visual field in an automatic way. Algorithms that select what locations and intensities to present over time are called strategies. These have the goal to provide both a fast and accurate estimation of the visual field function.

Recently, new strategies were developed that are faster and equally accurate as the strategies used today. The technological advancement of these new methods lies primarily in the ability to estimate location sensitivities without observing them directly but by leveraging previously queried locations. For this the investigators plan to implement the next generation of perimetry strategies into an OCTOPUS 900 and to test it in healthy subjects and glaucoma patients.


Condition or disease Intervention/treatment
Glaucoma, Open-Angle Diagnostic Test: Visual field testing

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Study Type : Observational
Estimated Enrollment : 101 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Non-inferiority Study for Visual Field Mean Defect Estimation Using Sequentially Optimized Reconstruction Strategy (SORS) With an OCTOPUS 900 Perimeter on Healthy and Glaucoma Subjects
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort Intervention/treatment
Healthy subjects Diagnostic Test: Visual field testing
Standard Automated Perimetry using a perimeter is one of the most commonly used techniques for measuring perceived visual ability of a subject. For a given eye, it provides quantitative measurements of visual function represented as a 2D spatial visual field map. It is of great clinical importance for diagnosing and monitoring glaucoma and detecting neurological conditions.

Glaucoma subjects
Patients with primary open-angle-, pseudoexfoliation- or primary angle-closure glaucoma
Diagnostic Test: Visual field testing
Standard Automated Perimetry using a perimeter is one of the most commonly used techniques for measuring perceived visual ability of a subject. For a given eye, it provides quantitative measurements of visual function represented as a 2D spatial visual field map. It is of great clinical importance for diagnosing and monitoring glaucoma and detecting neurological conditions.




Primary Outcome Measures :
  1. Non-inferiority estimation quality of mean defect between SORS and dynamic strategy visual field locations [ Time Frame: 12 months ]
    The primary endpoint of this study is the non-inferiority estimation quality of mean defect when using SORS visual field locations as compared to the dynamic strategy visual field locations in healthy subjects and glaucoma patients with early or moderate visual field loss. The non-inferiority margin is defined as a mean defect difference of no more than 0.5 decibel to the dynamic strategy measurement.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy subjects and subjects with Primary open-angle-, pseudoexfoliation- or primary angle-closure glaucoma
Criteria

Inclusion Criteria:

  • Cataract yes or no
  • Age range 40 - 80 years
  • Normal visual field (MD: < +2 dB)
  • Refractive error within ±5 dpt. spherical equivalent
  • Astigmatism of < -3 dpt.
  • Visual acuity of ≥0.3 logMar (decimal ≥0.5)
  • Experience in perimetry (history of at least one perimetry examination)
  • False positive or negative errors each less than 20% in each examination
  • Primary open-angle/ pseudoexfoliation/ primary angle-closure glaucoma
  • Early to moderate visual field loss (MD: +2 to +12 dB)
  • Written informed consent

Exclusion Criteria:

Exclusion criteria are children (<18 years old), inability to follow the procedure, insufficient knowledge of project language, the history of other ocular diseases than glaucoma or cataract or other conditions that might affect visual field testing (e.g. pituitary lesions, demyelinating diseases).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325751


Contacts
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Contact: René G Höhn, M.D. +41 31 63 29717 rene.hoehn@insel.ch

Locations
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Switzerland
Department of Ophthalmology, Inselspital, University Hospital Bern Recruiting
Bern, Switzerland, 3010
Contact: René G Höhn, M.D.    +41 31 63 29717    rene.hoehn@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Investigators
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Principal Investigator: René G Höhn, M.D. Department of Ophthalmology, Inselspital, University Hospital Bern, University of Bern, Bern, Switzerland

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03325751     History of Changes
Other Study ID Numbers: 2017-01540
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases