Clinical trial NCT01075542: Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens
Official title: Efficacy and Cost-effectiveness of Toric Intraocular Lenses in Correcting Astigmatism in Cataract Surgery: a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Keywords: Corneal astigmatism
Intraocular lens
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2010-02-25
Enrollment: 86
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Bilateral cataract
* Bilateral corneal astigmatism (at least 1.25D)
* Predicted residual astigmatism less than 0.5D

Exclusion Criteria:

* Irregular corneal astigmatism or keratoconus
* Fuchs endothelial dystrophy (stage 2)
* Expected postoperative best-corrected visual acuity worse than logMAR +0.3

Primary outcomes:
measure: Spectacle independency
timeFrame: preop, 3 months and 6 months postop
Secondary outcomes:
measure: Visual acuity
timeFrame: preop, 1 day, 1 month, 3 months and 6 months postop
measure: Refractive astigmatism
timeFrame: preop, 3 months and 6 months postop
measure: Higher-order wavefront aberrations
timeFrame: preop, 3 months and 6 months postop
measure: Contrast sensitivity
timeFrame: preop, 3 months and 6 months postop
measure: Costs related to intervention
timeFrame: preop, 3 and 6 months postop
measure: Quality of vision
timeFrame: preop, 3 months, 6 months
Other outcomes:
Locations:
city: Heerlen, Brunssum, Kerkrade
country: Netherlands
facility: Atrium Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Rotterdam
country: Netherlands
facility: Rotterdam Eye Hospital
Study officials:
affiliation: Maastricht University Medical Centre
name: Rudy Nuijts, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bauer NJ, de Vries NE, Webers CA, Hendrikse F, Nuijts RM. Astigmatism management in cataract surgery with the AcrySof toric intraocular lens. J Cataract Refract Surg. 2008 Sep;34(9):1483-8. doi: 10.1016/j.jcrs.2008.05.031.
citation: Visser N, Beckers HJ, Bauer NJ, Gast ST, Zijlmans BL, Berenschot TT, Webers CA, Nuijts RM. Toric vs aspherical control intraocular lenses in patients with cataract and corneal astigmatism: a randomized clinical trial. JAMA Ophthalmol. 2014 Dec;132(12):1462-8. doi: 10.1001/jamaophthalmol.2014.3602.