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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00366496
Enrollment
30
Registered
2006-08-21
Start date
2004-07-31
Completion date
2005-05-31
Last updated
2006-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Extraction

Brief 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.

Interventions

DEVICEAcrysof single piece (SA60AT)
DEVICEAcrysof IQ (SN60WF)

Sponsors

Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
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

* 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

Design outcomes

Primary

MeasureTime frame
Contrast sensitivity
Visual acuity

Secondary

MeasureTime frame
Induction of hight order aberrations
Corneal topography
Patient satisfaction

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026