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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03325751
Other study ID # 2017-01540
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date November 1, 2019

Study information

Verified date January 2020
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date November 1, 2019
Est. primary completion date August 2, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 80 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Switzerland Department of Ophthalmology, Inselspital, University Hospital Bern Bern

Sponsors (2)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Non-inferiority estimation quality of mean defect between SORS and dynamic strategy visual field locations 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. 12 months
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