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Completed

NCT Number: NCT01075542

Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens

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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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Medical Center, Heerlen, Brunssum, Kerkrade, Netherlands

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AcrySof Toric intraocular lens, model SN60TT

Device

The lens is made of foldable acrylic material and is implanted in the capsular bag

AcrySof Monofocal IOL, model SN60AT

Device

The lens is made of foldable acrylic material and is implanted in the capsular bag

Primary outcomes

  1. Spectacle independency

    Time frame: preop, 3 months and 6 months postop

    Spectacle independency for distance vision

Secondary outcomes

  1. Visual acuity

    Time frame: preop, 1 day, 1 month, 3 months and 6 months postop

  2. Refractive astigmatism

    Time frame: preop, 3 months and 6 months postop

  3. Higher-order wavefront aberrations

    Time frame: preop, 3 months and 6 months postop

  4. Contrast sensitivity

    Time frame: preop, 3 months and 6 months postop

  5. Costs related to intervention

    Time frame: preop, 3 and 6 months postop

    Total cost-analysis, including out-of-hospital costs for patient

  6. Quality of vision

    Time frame: preop, 3 months, 6 months

    Refractive-error related quality of vision

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 25, 2010
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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