A Comparative Study of Six Methods to Measure Human Contrast Vision

Methods to Measure Contrast Vision Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02767284
• Other study ID #: UCST-01.2014
• Status: Recruiting
• Phase: N/A
• First received: May 4, 2016
• Last updated: June 27, 2016
• Start date: June 2016
• Est. completion date: October 2017

Study information

• Verified date: June 2016
• Source: Uppsala University
• Contact: Lars Malmqvist, M.D
• Phone: +46186115135
• Email: lars.malmqvist[@]neuro.uu.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

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]].

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Methods to Measure Contrast Vision

Intervention

Device:
• UCST-V1
A previously developed device, Uppsala Contrast Sensitivity Tester - UCST-V1, that quickly measures the human CSF in one stimulus.
• UCST-V2
A refined version of the UCST-V1 that randomizes frequency order.
• UCST-V3
A version that utilises eye-tracking technology to make the measurements more accurate.
• Quick-CSF (QCSF)
A fast contrast sensitivity measurement method using a Bayesian algorithm.
• Pelli-Robson
A standard method developed using a Sloan-letter chart with decreasing contrast.
• Optec 6500
A standard test using sinusoidal gratings to measure the contrast sensitivity function.

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No