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Impact of Glistenings in AcrySof Intraocular Lenses on Visual Quality

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01202981
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : December 11, 2014
Information provided by (Responsible Party):
University of Utah

Brief Summary:
This study will assess the impact of IOL glistenings on visual quality and function in patients implanted with a single-piece AcrySof intraocular lens (IOL) that exhibits glistening formations. The primary objective is to determine if random light scattering (measured by C-Quant)correlates with severity of glistenings, other objective measures of visual function (visual acuity, low contrast visual acuity, low contrast visual acuity with glare), and subjective measures of patients' perceptions of their visual quality after cataract surgery (quality of life survey, reports of symptomology and satisfaction).

Condition or disease
Lenses, Intraocular Glistenings Visual Quality

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of IOL Glistenings on Visual Quality and Function in Patients Implanted With a Single-Piece AcrySof IOL That Exhibits Glistening Formation
Study Start Date : July 2010
Primary Completion Date : December 2012
Study Completion Date : June 2013

Group 1
Patients who had cataract surgery by the Investigators between July 1, 2007 and June 30, 2008.
Group 2
Patients who had cataract surgery by the Investigators between July 1, 2008 and July 1, 2009.

Primary Outcome Measures :
  1. Light scattering [ Time Frame: Post-opertative ]
    Correlation of random light scattering (measured with the C-Quant device) with severity of glistenings in the lenses

Secondary Outcome Measures :
  1. Visual function [ Time Frame: Post-operative ]
    Correlation of visual function (visual acuity, contrast acuity and constrast acuity with glare)with glistening severity

  2. Visual quality [ Time Frame: Post-operative ]
    Correlation of visual quality (measured with quality of life questionnaire, and subjective reports of symptoms) with glistening severity

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Enrollment will be stratified into two patient groups based on time since surgery: (1) one to two years post-operative, and (2) two to three years post-op.

Inclusion Criteria:

  1. Presence of obvious glistenings by slit lamp exam
  2. Best spectacle corrected visual acuity of 20/20 or better on the Snellen chart at most recent exam

Exclusion Criteria:

  1. Any central corneal pathology that could have impact on vision other than mild guttata felt unlikely to have any impact on corneal clarity.
  2. Any documented glaucoma of any kind.
  3. Any macular pathology except minimal drusen without retinal pigment epithelial pathology felt to be consistent with normal vision.
  4. Any diabetic retinopathy other than minimal background diabetic retinopathy felt unlikely to affect vision.
  5. Any other cause of central visual acuity loss including optic nerve, occipital cortex dysfunction or amblyopia.
  6. Diagnosis of dry eye syndrome, defined as any corneal staining with fluorescein
  7. Presence of any central posterior capsular opacification. Previous YAG laser capsulotomy is allowed.
  8. Any surgical complication having to do with the capsule such as a broken capsule or zonular dialysis or iris trauma or any other complication felt to in any way impact upon the quality of the visual result.
  9. Any contraindication to pupil dilation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01202981

United States, Utah
University of Utah, John Moran Eye Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Principal Investigator: Randall J Olson, MD University of Utah

Responsible Party: University of Utah Identifier: NCT01202981     History of Changes
Other Study ID Numbers: 42093
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by University of Utah:
contrast sensitivity
visual quality
AcrySof IOL