A comparison of widely used clinical contrast sensitivity tests: the relation between defocus specific contrast sensitivity and higher order aberrations

ISRCTN	ISRCTN66724598
DOI	https://doi.org/10.1186/ISRCTN66724598
Secondary identifying numbers	NL799, NTR812

Submission date: 01/12/2006
Registration date: 01/12/2006
Last edited: 06/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms K W van Gaalen
Scientific

University Medical Center
Groningen
Department of Ophtalmology
P.O. Box 30001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 3619692
Email	k.van.gaalen@ohk.umcg.nl

Study information

Study design	Randomised parallel armed clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	A comparison of widely used clinical contrast sensitivity tests: the relation between defocus specific contrast sensitivity and higher order aberrations
Study acronym	Defocus specific contrast sensitivity and spherical aberration
Study objectives	Higher order aberrations, like spherical aberration, decreases visual performance.
Ethics approval(s)	Medisch Ethische Toetsingscommissie, University Medical Center Groningen, date of MEC approval: 14 Oct 2005 (reference number: METc2005.188).
Health condition(s) or problem(s) studied	No condition, healthy person
Intervention	Best corrected visual acuity was determined with an Early Treatment Diabetic Retinopathy Study (ETDRS ) chart and the Spherical Aberration (SA) was measured with a wavefront analyzer (WASCA version 1.26.3, Asclepion Meditec, Jena, Germany). The contrast sensitivity is measured with two computerised tests: 1. One with vertical sine-wave gratings (1.5-12 cpd) generated on a CRT (Cambridge Research Systems, Rochester, UK; Von Bekesy tracking method) 2. The Holladay sine-wave (1.5 -18 cpd) modulated circular lines (HACSS) (M&S Technologies, Skokie, Illinois, USA), and with six contrast sensitivity chart tests: 1. Pelli Robson contrast sensitivity test 2. Low contrast ETDRS-like optotype chart 2.5% 3. Low contrast ETDRS-like optotype chart 10% 4. Edge contrast sensitivity test: GECKO 5. Edge contrast sensitivity test: GECKO-100 6. Vector Vision Contrast sensitivity is measured in mesopic (3 cd/m^2) and photopic (160 cd/m^2) conditions, using only the dominant eye. Tests were performed at optimal refractive state of the eye and at a variety of defocus situations (-2D to 2D).
Intervention type	Other
Primary outcome measure	Selection of the contrast sensitivity test which predicts the spherical aberration most reliably.
Secondary outcome measures	1. Spherical aberration as function of age 2. RMS as function of age 3. Contrast sensitivity as function of age 4. Influence of defocus on contrast sensitivity
Overall study start date	01/07/2005
Completion date	30/06/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	48
Total final enrolment	48
Key inclusion criteria	No ocular pathology
Key exclusion criteria	1. Refractive correction larger than +/- 2 D 2. Cylindrical correction larger than 1.5 D 3. Cylindrical axis more then 20° from the horizontal or vertical axis
Date of first enrolment	01/07/2005
Date of final enrolment	30/06/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center

Groningen
9700 RB
Netherlands

Sponsor information

University Medical Center Groningen (The Netherlands)
Hospital/treatment centre

Department of Ophthalmology
P.O. Box 30001
Groningen
9700 RB
Netherlands

Website	http://www.umcg.nl/azg/nl/english/azg/
"ROR"	https://ror.org/03cv38k47

Funders

Funder type

Government

SenterNovem (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	results presented at ARVO	01/05/2007	06/01/2021	No	No

Editorial Notes

06/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.