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

NCT03325751 | Completed

• 1 other identifier: 2017-01540
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Healthy subjects

Diagnostic Test: Visual field testing

Glaucoma subjects

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

Diagnostic Test: Visual field testing

Interventions

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.

Glaucoma subjects; Healthy subjects

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy subjects and subjects with Primary open-angle-, pseudoexfoliation- or primary angle-closure glaucoma

You may qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

Department of Ophthalmology, Inselspital, University Hospital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Visual Fields

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena

Study Officials

• René G Höhn, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 30, 2017
• Study Start: June 1, 2018
• Primary Completion: August 2, 2019
• Study Completion: November 1, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

CH (1)