No registrations found.
ID
Source
Brief title
Health condition
Each patient will receive a spherical IOL in one eye and an aspherical IOL in the fellow eye. The spherical IOL is normally used, the aspherical is not. The IOL's are CE approved.
Sponsors and support
Hanzeplein 1
Postbus 30.001
9700 RB Groningen
The Netherlands
Tel: (+31)050-3612510
Fax: (+31)050-3611709
AMO (advanced medical optics) Groningen B.V.
Van Swietenlaan 5
9728 NX Groningen
Tel: (+31)050-5296600
Fax: (+31)050-5267860
Intervention
Outcome measures
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.
Background 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.
Study objective
Implantation of aspheric IOL's results in higher visual performance than spheric IOL's.
Intervention
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.
Groningen (UMCG), Department Ophtalmology,
P.O. box 30.001
K.W. Gaalen, van
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 3619692
k.van.gaalen@ohk.umcg.nl
Groningen (UMCG), Department Ophtalmology,
P.O. box 30.001
K.W. Gaalen, van
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 3619692
k.van.gaalen@ohk.umcg.nl
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL800 |
| NTR-old | NTR813 |
| Other | : 2 |
| ISRCTN | ISRCTN17058178 |