AcrySof Toric intraocular lens, model SN60TT
DeviceThe lens is made of foldable acrylic material and is implanted in the capsular bag
NCT Number: NCT01075542
The purpose of this study is to determine if Toric intraocular lens implantation in cataract surgery is a more efficient and cost-effective treatment of astigmatism than Monofocal intraocular lens implantation.
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Notify Me21 year and older
All sexes
Interventional
Not applicable
Atrium Medical Center, Heerlen, Brunssum, Kerkrade, Netherlands
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.
Objective: The primary objective of this study is to compare spectacle independence for distance vision following toric IOL implantation and monofocal intraocular lens (IOL) implantation. The secondary objectives are to compare uncorrected distance vision, residual refractive astigmatism, quality of vision, wavefront aberrations, contrast sensitivity, complication profile, costs of postoperative spectacles and cost-effectiveness.
Study design: Multi-centre randomised clinical trial. Study population: 160 patients with regular corneal astigmatism of at least 1.25 diopters in both eyes who require bilateral cataract surgery.
Intervention: Cataract surgery with implantation of a toric IOL (AcrySof model SN60TT) or an monofocal IOL (AcrySof model SN60AT).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The lens is made of foldable acrylic material and is implanted in the capsular bag
The lens is made of foldable acrylic material and is implanted in the capsular bag
Time frame: preop, 3 months and 6 months postop
Spectacle independency for distance vision
Time frame: preop, 1 day, 1 month, 3 months and 6 months postop
Time frame: preop, 3 months and 6 months postop
Time frame: preop, 3 months and 6 months postop
Time frame: preop, 3 months and 6 months postop
Time frame: preop, 3 and 6 months postop
Total cost-analysis, including out-of-hospital costs for patient
Time frame: preop, 3 months, 6 months
Refractive-error related quality of vision
Maastricht University Medical Center
Other
Efficacy and Cost-effectiveness of Toric Intraocular Lenses in Correcting Astigmatism in Cataract Surgery: a Randomised Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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