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CompletedNCT00366496Updated Aug 21, 2006

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

An interventional study of Acrysof single piece (SA60AT) and Acrysof IQ (SN60WF) in Cataract Extraction, sponsored by Medical University of South Carolina. Completed. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2006-08-21.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cataract Extraction

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

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Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
30 participants

Interventions

  • DeviceAcrysof single piece (SA60AT)
  • DeviceAcrysof IQ (SN60WF)
06

What researchers measure

Primary outcomes

  1. Contrast sensitivity

  2. Visual acuity

Secondary outcomes

  1. Induction of hight order aberrations

  2. Corneal topography

  3. Patient satisfaction

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00366496
Lead sponsor
Medical University of South Carolina
First posted
Aug 21, 2006
Start date
Jul 2004
Completion
May 2005
Last update
Aug 21, 2006

Study contacts

Kerry D. Solomon, MD
principal investigator · Medical University of South Carolina
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2005. You cannot join it, but the record below documents what was studied.

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