Clinical trial NCT03325751: Visual Field Defect Estimation Using Sequentially Optimized Reconstruction Strategy on Healthy and Glaucoma Subjects
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2017-10-30
Enrollment: 103
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects and subjects with Primary open-angle-, pseudoexfoliation- or primary angle-closure glaucoma

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.


Eligibility 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).

Primary outcomes:
measure: Non-inferiority estimation quality of mean defect between SORS and dynamic strategy visual field locations
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Ophthalmology, Inselspital, University Hospital Bern
Study officials:
affiliation: Department of Ophthalmology, Inselspital, University Hospital Bern, University of Bern, Bern, Switzerland
name: René G Höhn, M.D.
role: PRINCIPAL_INVESTIGATOR
References: