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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03325751
Enrollment
103
Registered
2017-10-30
Start date
2018-06-01
Completion date
2019-11-01
Last updated
2020-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Open-Angle

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.

Interventions

DIAGNOSTIC_TESTVisual 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.

Sponsors

University of Bern
CollaboratorOTHER
Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Non-inferiority estimation quality of mean defect between SORS and dynamic strategy visual field locations12 monthsThe 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026