| - candidate number | 2325 |
| - NTR Number | NTR813 |
| - ISRCTN | ISRCTN17058178 |
| - Date ISRCTN created | 1-dec-2006 |
| - date ISRCTN requested | 1-dec-2006 |
| - Date Registered NTR | 20-nov-2006 |
| - Secondary IDs | 2 |
| - Public Title | Effect of improved intraocular lenses on contrast sensitivity tests. |
| - Scientific Title | Effect of improved intraocular lenses on contrast sensitivity tests. |
| - ACRONYM | Aspheric IOL and contrast sensitivity |
| - hypothesis | Implantation of aspheric IOL's results in higher visual performance than spheric IOL's. |
| - Healt Condition(s) or Problem(s) studied | Cataract |
| - Inclusion criteria | Cataract in both eyes. |
| - Exclusion criteria | 1. Other ocular pathology as diabetic, macula degeneration and glaucoma; 2. Cylinder larger than 1,5 D; 3. Medication that influences the tear function of the eye; 4. Pathology that influences the tear production; 5. Prevalance of pathology between the two cataract operations; 6. Younger than 18 years; 7. Prevalance of senile dementia (MMSE<22). |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Active |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-nov-2006 |
| - planned closingdate | 1-okt-2008 |
| - Target number of participants | 60 |
| - Interventions | Two groups of 30 patients, each group tested with a specific intraocular lens (IOL) type in a spheric and aspheric design. In each patient a spherical IOL is placed in one eye and an aspherical IOL in the fellow eye. The IOL's used in the first combination are acrylic based and the IOL's used in the second combination are silicone based. Both combinations of IOL's are CE-approved. After implantation of the IOL in the second eye, the patient will perform two different contrast sensitivity tests at optimal refractive state of the eye and at -2D, -1D, +1D and +2D defocus. In this studie, the spherical aberration, corneal topography and stray light will also be measured. |
| - Primary outcome | Improvement of the contrast sensitivity in the aspheric IOL. |
| - Secondary outcome | 1. No decrease of depth of focus. 2. No difference in intraocular stray light. |
| - Timepoints | |
| - Trial web site | N/A |
| - status | open: patient inclusion |
| - 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 | Refractive surgery is a surgical treatment, which aims for the correction of refractive errors. Nowadays, there is a strong tendency to perform refractive surgery in such a way that spherical aberration and other optical abnormalities after the operation are minimal. In patients with cataract, this can be achieved by replacing the cataracteus lens by a synthetic aspherical IOL (intra-ocular lens). An aspherical IOL contains negative spherical aberration which compensates the positive spherical aberration of the cornea. |
| - Main changes (audit trail) | |
| - RECORD | 20-nov-2006 - 5-dec-2006 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl