A Comparative Study of Six Methods to Measure Human Contrast Vision

UCST Studie 1 - Jämförande Studie Mellan några Befintliga Och Nyutvecklade Metoder för Att mäta Den Spektrala kontrastkänslighetsfunktionen Hos människa

This study evaluates the relative performance of different methods to measure the human spectral contrast sensitivity function (CSF).

Study Overview

• Status: Unknown
• Conditions: Methods to Measure Contrast Vision
• Intervention / Treatment: Device: UCST-V1; Device: UCST-V2; Device: UCST-V3; Device: Quick-CSF (QCSF); Device: Pelli-Robson; Device: Optec 6500

Detailed Description

The human spectral contrast sensitivity function (CSF) is a better way to estimate human vision than letter charts commonly used by ophthalmologists, optometrists and opticians.

The current methods used to measure the CSF are often unreliable, due to high variability between measurements. This study will compare four (4) new tests with two (2) currently used standard tests. The contrast sensitivity function will be measured using all of the six (6) methods three times (3) in each of the two (2) eyes at two (2) occasions. Each subjects CSF will be measured 6x3x2x2 = 72 times.

In addition, for each of the CSF measurements, the time used to measure the CSF and number of background variables for the subjects will be recorded.

After informed consent is obtained, the subjects will undergo a visual examination. If they match the inclusion criteria they will be included. At that time or at their earliest possible convenience, their CSF will be measured using the six methods and some background information will be recorded.

The follow-up measurement occasion will occur between 4 to 6 weeks (28 to 42 days) after the first.

To facilitate comparison with previous studies, the CSF-measurements (in rel. contrast/cycles/degree) will be converted to a log (Base 10 logarithm) scale. The unit will thus be log CSF (LCSF) [log[relative contrast]/log[cycles/per degree]].

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 75185
    • Recruiting
    • Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Normal best corrected visual acuity: LogMAR = 0
• No current or previous eye disease in either eye.
• Student at Uppsala University

Exclusion Criteria:

• Previous surgery in any eye
• Inability to follow the test procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UCST-V1; The UCST-V1 contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover)	Device: UCST-V1; A previously developed device, Uppsala Contrast Sensitivity Tester - UCST-V1, that quickly measures the human CSF in one stimulus.
Experimental: UCST-V2; The UCST-V2 contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover)	Device: UCST-V2; A refined version of the UCST-V1 that randomizes frequency order.
Experimental: UCST-V3; The UCST-V3 contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover)	Device: UCST-V3; A version that utilises eye-tracking technology to make the measurements more accurate.
Experimental: Quick-CSF; The Quick-CSF test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover)	Device: Quick-CSF (QCSF); A fast contrast sensitivity measurement method using a Bayesian algorithm.
Active Comparator: Pelli-Robson; The Pelli-Robson contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover)	Device: Pelli-Robson; A standard method developed using a Sloan-letter chart with decreasing contrast.
Active Comparator: Optec 6500; The Optec 6500 contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover)	Device: Optec 6500; A standard test using sinusoidal gratings to measure the contrast sensitivity function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average time (in seconds) used to measure the contrast sensitivity function for one eye for each method		At end of data collection (up to 12 months after first subject is included)
Average area under the curve for the log contrast sensitivity function (AULCSF) in one eye for each method	The area-under-curve of the LCSF, calculated from the measured CSF.	At end of data collection (up to 12 months after first subject is included)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sources of variability of the average time used to measure the contrast sensitivity function [seconds squared]	The factors occasion, eye, acuity, measurement order, sex,examiner will used in an ANOVA	At end of data collection (up to 12 months after first subject is included)
Sources of variability of the average area under the curve for the log contrast sensitivity function [AULCSF squared]	The factors occasion, eye, acuity, measurement order, sex,examiner will used in an ANOVA	At end of data collection (up to 12 months after first subject is included)

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Prof. Per Söderberg, M.D PhD, Uppsala University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: May 9, 2016
• First Posted (Estimate): May 10, 2016

Study Record Updates

• Last Update Posted (Estimate): June 28, 2016
• Last Update Submitted That Met QC Criteria: June 27, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Contrast Sensitivity; Diagnostic Techniques, Ophthalmological
• Other Study ID Numbers: UCST-01.2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymous or pseudo-anonymous data will be available on request or in a repository.