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

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.

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, Inselspital, University Hospital Bern

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

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

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).

Treatment and study plan

Visual field testing

Diagnostic Test

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

University of Bern

Registry information

Official study 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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Oct 30, 2017
Registry last updated: Jan 9, 2020

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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Completed