| - candidate number | 2324 |
| - NTR Number | NTR812 |
| - ISRCTN | ISRCTN66724598 |
| - Date ISRCTN created | 1-dec-2006 |
| - date ISRCTN requested | 1-dec-2006 |
| - Date Registered NTR | 17-nov-2006 |
| - Secondary IDs | 1 |
| - 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. |
| - ACRONYM | Defocus specific contrast sensitivity and spherical aberration |
| - hypothesis | Higher order aberrations, like spherical aberration, decreases visual performance. |
| - Healt Condition(s) or Problem(s) studied | No condition, healthy person |
| - 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 20º from the horizontal or vertical axis. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | None |
| - control | Not applicable |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-jul-2005 |
| - planned closingdate | 30-jun-2006 |
| - Target number of participants | 48 |
| - Interventions | 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 | Selection of the contrast sensitivity test which predicts the spherical aberration most reliably. |
| - Secondary outcome | 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. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Drs. K.W. Gaalen, van |
| - CONTACT for SCIENTIFIC QUERIES | Drs. K.W. Gaalen, van |
| - Sponsor/Initiator | University Medical Center Groningen (UMCG), Department Ophtalmology, Advanced Medical Optics (AMO) Groningen BV |
| - Funding (Source(s) of Monetary or Material Support) | SenterNovem |
| - Publications | N/A |
| - Brief summary | The relation between contrast sensitivity and spherical aberration and other higher order aberrations (RMS) will be studied in young and elderly subjects without ocular pathology. Contrast sensitivity will be assessed with the use of eight different contrast sensitivity tests at optimal focus and at positive and negative defocus. These results will be related to the higher order aberrations of the eyes. |
| - Main changes (audit trail) | |
| - RECORD | 17-nov-2006 - 26-nov-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl