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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: Netherlands Trial Register
Last refreshed on: 28 April 2013
Main ID:  NTR812
Date of registration: 17/11/2006
Primary sponsor: University Medical Center Groningen (UMCG), Department Ophtalmology
Public title: A comparison of widely used clinical contrast sensitivity tests: the relation between defocus specific contrast sensitivity and higher order aberrations.
Scientific title: A comparison of widely used clinical contrast sensitivity tests: the relation between defocus specific contrast sensitivity and higher order aberrations. - Defocus specific contrast sensitivity and spherical aberration
Date of first enrolment: 1/7/2005
Target sample size: 48
Recruitment status: complete
URL:  http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=812
Study type:  intervention
Study design:  Randomised: Yes; Masking: None; Control: Not applicable; Group: Parallel; Type: 2 or more arms, randomized  
Countries of recruitment
The Netherlands
Contacts
Name: K.W.  Gaalen, van
Address:  University Medical Center Groningen (UMCG), Department Ophtalmology, P.O. box 30.001, Hanzeplein 1 9700 RB Groningen The Netherlands
Telephone: +31 (0)50 3619692
Email: k.van.gaalen@ohk.umcg.nl
Affiliation: 
Name: K.W.  Gaalen, van
Address:  University Medical Center Groningen (UMCG), Department Ophtalmology, P.O. box 30.001, Hanzeplein 1 9700 RB Groningen The Netherlands
Telephone: +31 (0)50 3619692
Email: k.van.gaalen@ohk.umcg.nl
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: No ocular pathology.
Exclusion criteria: 1. Refractive correction larger than +/- 2 D;

2. Cylindrical correction larger than 1.5 D;

3. Cylindrical axis more then 20ยบ from the horizontal or vertical axis.


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
No condition, healthy person

Intervention(s)
Best corrected visual acuity was determined with an 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 computerized 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/m2) and photopic (160 cd/m2) 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).
Primary Outcome(s)
Selection of the contrast sensitivity test which predicts the spherical aberration most reliably.
Secondary Outcome(s)
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.
Secondary ID(s)
ISRCTN66724598
Source(s) of Monetary Support
SenterNovem
Secondary Sponsor(s)
Advanced Medical Optics (AMO) Groningen BV
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