Skip to main content
OpenTrials
Completed

NCT Number: NCT00366496

Surgical Outcomes After Routine Cataract Extraction & Implantation of a Conventional or Spheric Intraocular Lens

To determine quality of vision post cataract extraction and intraocular lens (IOL) implantation of 2 different acrylic intraocular lenses: Acrysof® Single-Piece IOL and Acrysof® WF, through evaluation of contrast sensitivity, glare testing, visual outcomes, wavefront, corneal topography, and patient satisfaction.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Unilateral or bilateral cataract
  • Eligible for phacoemulsification with primary implantation of a posterior chamber IOL. If bilateral, patient will receive the same IOL than the fellow eye.
  • Expected maximum of 4 weeks and minimum of 1 week interval between primary and second eye surgeries when bilateral.
  • Best corrected visual acuity (BCVA) should be no better than 20/40 in the presence of a glare source using Snellen visual acuity. In the Snellen visual acuity chart, better than 20/40 will be at least 3 letters read correctly in the 20/30 line.
  • Naturally dilated pupil (in dim light) ≥ 4.0 mm in both eyes.

Exclusion criteria

  • Preoperative ocular pathology potentially affecting visual acuity
  • Previous intraocular or corneal surgery.
  • Keratometric astigmatism exceeding 1.5 diopters.
  • Planned postoperative refraction for mono-vision.
  • Current contact lens usage.
  • Other ocular surgery at the time of the cataract extraction.
  • Uncontrolled diabetes.
  • Any neurological condition that might interfere with performance of required test.
  • Auto-immune deficiency disease.
  • Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
  • Use of any systemic or topical drug known to interfere with visual performance.

Surgical Exclusion Criteria

  • Significant anterior chamber bleeding.
  • Detached Descemet's membrane
  • Iris damage
  • Posterior capsule rupture
  • Radial tear in capsulorhexis
  • Vitreous loss
  • Zonular rupture.
  • Use of corneal sutures for more than 1 week.

Post-implantation Exclusion Criteria

  • Haptic not in the capsular bag.
  • Descentration of the IOL of more than 1.0 mm
  • Ocular pathologies potentially affecting visual acuity that were not evident prior to surgery.

Treatment and study plan

Acrysof single piece (SA60AT)

Device

Acrysof IQ (SN60WF)

Device

Primary outcomes

  1. Contrast sensitivity

  2. Visual acuity

Secondary outcomes

  1. Induction of hight order aberrations

  2. Corneal topography

  3. Patient satisfaction

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Comparison of Visual Outcomes, Wavefront Analysis, Contrast Sensitivity and Glare Testing Following Cataract Extraction Between Acrysof Single-Piece IOL and Acrysof WF

Important dates

Study start
2004
Study completion
2005
First posted
Aug 21, 2006
Registry last updated
Aug 21, 2006

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.

Published trials that share one or more normalized conditions with this study.