Quantification of Agreement and Variability of a Newly Developed Visual Field Algorithm With the Reference Standard

NCT02727569 | Completed

• 1 other identifier: GART1046
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare two types of visual field test; retinal sensitivity values obtained with the reference standard Swedish Interactive Thresholding Algorithm (SITA) of the standard visual field test and with a newly developed test algorithm. The new test is a visual field test presented on a flat-panel monitor and has two modes: differential light sensitivity (DLS; equivalent to the standard visual field test) and the Moorfields Motion Displacement Test (MMDT). DLS sensitivity and DLS measurement variability will be determined and compared between the SITA algorithm of the standard visual field test and the new visual field test on the flat-panel monitor. The measurement variability of the MMDT will be quantified. The long-term goal is to reduce test variability below that observed in SITA by 20%, whilst producing comparable measurements (contrast threshold values) for comparable test duration.

Conditions

Glaucoma; Healthy

Outcome Measures

Primary Outcomes (1)

• To quantify the threshold difference in the test-retest variability of DLS obtained with the new algorithm and the SITA algorithm. To quantify the threshold test-retest variability of the MMDT with the new algorithm.

  Through study completion, an average of 1 year.

Secondary Outcomes (6)

• To quantify the difference in DLS thresholds measured with the new and SITA algorithms across all retinal locations and for a range of visual field sensitivities.

  Through study completion, an average of 1 year.

• To determine whether any differences in thresholds obtained on the two algorithms vary with retinal eccentricity and stimulus energy. Mean difference for each location will be reported in decibels.

  Through study completion, an average of 1 year.

• To determine whether any differences in test-retest variability obtained on the two algorithms vary with retinal eccentricity and stimulus energy. Mean difference between test-retest for each location will be reported in decibels.

  Through study completion, an average of 1 year.

• Participants preference for a more reliable visual fields test or for having a shorter test (questionnaire).

  Through study completion, an average of 1 year.

• Participants preference of test strategy, MMDT or DLS (questionnaire).

  Through study completion, an average of 1 year.

Study Arms (2)

Feasibility Study

10 subjects. Subjects will performed two different versions of the new visual field algorithm with DLS (differential light sensitivity) strategies. Two repeats of each strategy will be performed.

Device: New visual field algorithm with DLS

Clinical evaluation study

100 subjects. Subjects will performed a visual field assessment with the new visual field algorithm with MMDT (Moorfields Motion Displacement Test) and DLS -like stimuli and a commercial available SITA algorithm (DLS-like strategy). Two repeats of each strategy will be performed.

Device: New visual field algorithm with DLS; Device: SITA algorithm; Device: New visual field algorithm with MMDT

Interventions

New visual field algorithm with DLS DEVICE

Mathematical model (software based) to derive retinal sensitivity.

Clinical evaluation study; Feasibility Study

SITA algorithm DEVICE

Mathematical model (software based) to derive retinal sensitivity. Commercially available.

Clinical evaluation study

New visual field algorithm with MMDT DEVICE

Mathematical model (software based) to derive retinal sensitivity.

Clinical evaluation study

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited using three methods: 1. The volunteer database of the Glaucoma Research Unit. Letters will be sent to patients/healthy controls, who in the past agreed to be contacted for research purposes. Written information about the project will be sent with the letters. 2. Records screening. Patients' records will be screened in advance or during their clinical appointment. Persons identified as meeting the inclusion criteria will be invited to join the study, whereupon written information about the project will be given to the patient. Patients will be invited to join the study by letter, prior to their clinical appointment or in person on the day of the appointment. 3. Invitation of accompanying persons and staff. It is anticipated that spouses and acquaintances of existing subjects, as well as staff at the research site, Moorfields Eye Hospital and UCL Institute of Ophthalmology, may offer their participation as healthy volunteers.

You may qualify if:

• Best corrected visual acuity of 6/12 or better in the test eye
• No ocular morbidity other than glaucoma; early lens opacity and prior cataract surgery are acceptable
• Healthy eyes
• Central 30° visual field within normal limits on the 24-2 test (MD within 95 % CI and glaucoma hemifield test within normal limits).
• Glaucoma eyes
• More than two reliable visual fields with reproducible defects
• IOP \< 30 mmHg

You may not qualify if:

• Any systemic disease which is likely to affect visual performance in a short period of time
• Inability to steadily fixate on the test (e.g. individuals who have nystagmus or macular degeneration)
• Eyes with unreliable visual fields (defined as false positive responses \>15%)

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead

Study Sites (1)

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• David Garway-Heath, MD

  NIHR Biomedical Research Centre, Moorfields Eye Hospital and UCL Institute of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: April 4, 2016
• Study Start: June 15, 2017
• Primary Completion: June 29, 2018
• Study Completion: June 29, 2018
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

GB (1)