Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens

Astigmatism Clinical Trial

Official title:

Efficacy and Cost-effectiveness of Toric Intraocular Lenses in Correcting Astigmatism in Cataract Surgery: a Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075542
• Other study ID #: 082099
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: January 13, 2014
• Start date: February 2010
• Est. completion date: November 2012

Study information

• Verified date: January 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• AcrySof Toric intraocular lens, model SN60TT
The lens is made of foldable acrylic material and is implanted in the capsular bag
• AcrySof Monofocal IOL, model SN60AT
The lens is made of foldable acrylic material and is implanted in the capsular bag

Locations

Country	Name	City	State
Netherlands	Atrium Medical Center	Heerlen, Brunssum, Kerkrade
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Rotterdam Eye Hospital	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spectacle independency	Spectacle independency for distance vision	preop, 3 months and 6 months postop	No
Secondary	Visual acuity		preop, 1 day, 1 month, 3 months and 6 months postop	Yes
Secondary	Refractive astigmatism		preop, 3 months and 6 months postop	No
Secondary	Higher-order wavefront aberrations		preop, 3 months and 6 months postop	No
Secondary	Contrast sensitivity		preop, 3 months and 6 months postop	No
Secondary	Costs related to intervention	Total cost-analysis, including out-of-hospital costs for patient	preop, 3 and 6 months postop	No
Secondary	Quality of vision	Refractive-error related quality of vision	preop, 3 months, 6 months	No