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Trial record 68 of 7699 for:    Area Under Curve

A Comparative Study of Six Methods to Measure Human Contrast Vision

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ClinicalTrials.gov Identifier: NCT02767284
Recruitment Status : Unknown
Verified June 2016 by Uppsala University.
Recruitment status was:  Recruiting
First Posted : May 10, 2016
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
Uppsala University

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

Condition or disease Intervention/treatment Phase
Methods to Measure Contrast Vision Device: UCST-V1 Device: UCST-V2 Device: UCST-V3 Device: Quick-CSF (QCSF) Device: Pelli-Robson Device: Optec 6500 Not Applicable

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]].


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: UCST Studie 1 - Jämförande Studie Mellan några Befintliga Och Nyutvecklade Metoder för Att mäta Den Spektrala kontrastkänslighetsfunktionen Hos människa
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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.




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


Secondary Outcome Measures :
  1. Sources of variability of the average time used to measure the contrast sensitivity function [seconds squared] [ Time Frame: At end of data collection (up to 12 months after first subject is included) ]
    The factors occasion, eye, acuity, measurement order, sex,examiner will used in an ANOVA

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767284


Contacts
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Contact: Lars Malmqvist, M.D +46186115135 lars.malmqvist@neuro.uu.se
Contact: Gunneli Ekberg +46186115135

Locations
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Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden, 75185
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Prof. Per Söderberg, M.D PhD Uppsala University

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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02767284     History of Changes
Other Study ID Numbers: UCST-01.2014
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymous or pseudo-anonymous data will be available on request or in a repository.
Keywords provided by Uppsala University:
Contrast Sensitivity
Diagnostic Techniques, Ophthalmological