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

NCT ID: NCT03325751

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 103 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-11-01

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.

Conditions

Glaucoma, Open-Angle

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy subjects

Visual field testing

Intervention Type: 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.

Glaucoma subjects

Patients with primary open-angle-, pseudoexfoliation- or primary angle-closure glaucoma

Visual field testing

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bern

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

René G Höhn, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Inselspital, University Hospital Bern, University of Bern, Bern, Switzerland

Locations

Department of Ophthalmology, Inselspital, University Hospital Bern

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

2017-01540

Identifier Type: -

Identifier Source: org_study_id