Effect of improved intraocular lenses on contrast sensitivity tests

ISRCTN	ISRCTN17058178
DOI	https://doi.org/10.1186/ISRCTN17058178
Protocol serial number	NL800, NTR813
Sponsor	University Medical Center Groningen (The Netherlands)
Funder	SenterNovem (The Netherlands)

Submission date: 01/12/2006
Registration date: 01/12/2006
Last edited: 06/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms K W van Gaalen
Scientific

University Medical Center
Groningen
Department of Ophtalmology
P.O. Box 30001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 3619692
Email	k.van.gaalen@ohk.umcg.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled parallel armed trial
Secondary study design	Randomised controlled trial
Scientific title	Effect of improved intraocular lenses on contrast sensitivity tests
Study acronym	Aspheric IOL and contrast sensitivity
Study objectives	Implantation of aspheric Intra-Ocular Lenses (IOLs) results in higher visual performance than spheric IOLs.
Ethics approval(s)	Medisch Ethische Toetsingscommissie, University Medical Center Groningen, date of MEC approval: 25 Oct 2006 (reference number: METc2006.166). We asked for a small change in the protocol on 8 Nov 2006. For this change (amendment) we received approval on 29 Nov 2006 (also METc2006.166).
Health condition(s) or problem(s) studied	Cataract
Intervention	Two groups of 30 patients, each group tested with a specific 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 IOLs used in the first combination are acrylic based and the IOLs used in the second combination are silicone based. Both combinations of IOLs 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 study, the spherical aberration, corneal topography and stray light will also be measured.
Intervention type	Other
Primary outcome measure(s)	Improvement of the contrast sensitivity in the aspheric IOL.
Key secondary outcome measure(s)	1. No decrease of depth of focus. 2. No difference in intraocular stray light.
Completion date	01/10/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	30
Total final enrolment	30
Key inclusion criteria	Cataract in both eyes
Key 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 (Mini Mental State Examination [MMSE] less than 22)
Date of first enrolment	01/11/2006
Date of final enrolment	01/10/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center

Groningen
9700 RB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2010	06/01/2021	Yes	No

Editorial Notes

06/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.