The primary objective of this study is to compare the quality of vision following toric IOL implantation and monofocal IOL implantation. The secondary objectives are to compare uncorrected distance vision, spectacle dependence, residual refractive…
ID
Source
Brief title
Condition
- Vision disorders
- Eye therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the quality of vision, measured using a patient
questionnaire (the National Eye Institue 42 items Refractive Quality of LIfe,
NEI RQL-42)
Secondary outcome
Secondary endpoints are: visual acuity, frequency of spectacle wear, manifest
refraction, higher-order wavefront aberrations, contrast sensitivity,
occurrence of complications and costs of postoperative spectacles.
Background summary
A recent innovation in cataract surgery consists of the introduction of toric
intraocular lenses (IOLs) that can correct corneal astigmatism. It offers the
opportunity for patients with substantial astigmatism to achieve optimal
distance vision without using spectacles. Good near vision may subsequently be
achieved with low-cost reading glasses. The current practice of non-toric IOL
implantation in astigmatic patients warrants the use of expensive bifocal or
multifocal spectacles with cylinder correction to achieve good distance and
near vision. The toric IOL costs about ¤400 more than a non-toric IOL and it is
estimated that implementation of toric IOLs in cataract surgery could lead to a
considerable increase in costs of about ¤14.000.000. Before these new toric
IOLs can be implemented in the regular health care system their efficacy in
improving distance vision and cost-effectiveness have to be proven in a
randomised clinical trial.
Study objective
The primary objective of this study is to compare the quality of vision
following toric IOL implantation and monofocal IOL implantation. The secondary
objectives are to compare uncorrected distance vision, spectacle dependence,
residual refractive astigmatism, wavefront aberrations, contrast sensitivity,
complication profile, costs of postoperative spectacles and cost-effectiveness.
Study design
Multi-centre randomised controlled clinical trial.
Intervention
Cataract surgery with implantation of a toric IOL (AcrySof SN6ATT) or a
monofocal IOL (AcrySof SN60WF).
Study burden and risks
Most measurements and examinations in this study are part of the standard of
care in cataract surgery. Extra examinations are aberrometry, contrast
sensitivity and patient questionnaires. Aberrometry and contrast sensitivity
are non invasive, cause no side-effects and each take about 5 minutes to
perform. Patients will be asked to fill out questionnaires three times. Five
postoperative visits for each patient are included in this study, which is one
more compared to standard (sequential) cataract surgery. Patients will be
offered a travel compensation for this extra visit. We suspect that patients
implanted with a toric IOL might benefit from this study, because of an
improved distance vision and reduction in cost of postoperative spectacles.
P. Debyelaan 25
6202 AZ Maastricht
NL
P. Debyelaan 25
6202 AZ Maastricht
NL
Listed location countries
Age
Inclusion criteria
- Bilateral cataract
- Regular corneal astigmatism of minimal 1.25 diopters in both eyes
- Both eyes eligible for a toric intraocular lens implantation
Exclusion criteria
- Severe age-related macular degeneration
- Glaucoma related extensive visual field loss
- Extensive Diabetic macular disease
- Fuchs endothelial dystrophy
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| ClinicalTrials.gov | NCT01075542 |
| CCMO | NL29280.068.09 |