Condition category
Eye Diseases
Date applied
01/12/2006
Date assigned
01/12/2006
Last edited
14/12/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms K W van Gaalen

ORCID ID

Contact details

University Medical Center
Groningen
Department of Ophtalmology
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 3619692
k.van.gaalen@ohk.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2

Study information

Scientific title

Acronym

Aspheric IOL and contrast sensitivity

Study hypothesis

Implantation of aspheric Intra-Ocular Lenses (IOLs) results in higher visual performance than spheric IOLs.

Ethics approval

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).

Study design

Randomised controlled parallel armed trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Improvement of the contrast sensitivity in the aspheric IOL.

Secondary outcome measures

1. No decrease of depth of focus.
2. No difference in intraocular stray light.

Overall trial start date

01/11/2006

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Cataract in both eyes

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant 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)

Recruitment start date

01/11/2006

Recruitment end date

01/10/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (The Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.umcg.nl/azg/nl/english/azg/

Funders

Funder type

Government

Funder name

SenterNovem (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes