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van CCT (UK)


Effect of improved intraocular lenses on contrast sensitivity tests.


- candidate number2325
- NTR NumberNTR813
- ISRCTNISRCTN17058178
- Date ISRCTN created1-dec-2006
- date ISRCTN requested1-dec-2006
- Date Registered NTR20-nov-2006
- Secondary IDs
- Public TitleEffect of improved intraocular lenses on contrast sensitivity tests.
- Scientific TitleEffect of improved intraocular lenses on contrast sensitivity tests.
- ACRONYMAspheric IOL and contrast sensitivity
- hypothesisImplantation of aspheric IOL's results in higher visual performance than spheric IOL's.
- Healt Condition(s) or Problem(s) studiedCataract
- Inclusion criteriaCataract in both eyes.
- Exclusion criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-nov-2006
- planned closingdate1-okt-2008
- Target number of participants60
- InterventionsTwo 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 outcomeImprovement of the contrast sensitivity in the aspheric IOL.
- Secondary outcome1. No decrease of depth of focus. 2. No difference in intraocular stray light.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. K.W. Gaalen, van
- CONTACT for SCIENTIFIC QUERIESDrs. 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
- PublicationsN/A
- Brief summaryRefractive 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)
- RECORD20-nov-2006 - 5-dec-2006


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