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Impact of Glistenings in AcrySof Intraocular Lenses on Visual Quality

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01202981
First received: September 14, 2010
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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
Lenses, Intraocular
Glistenings
Visual Quality

Study Type: Observational
Study Design: 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

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Light scattering [ Time Frame: Post-opertative ] [ Designated as safety issue: No ]
    Correlation of random light scattering (measured with the C-Quant device) with severity of glistenings in the lenses


Secondary Outcome Measures:
  • Visual function [ Time Frame: Post-operative ] [ Designated as safety issue: No ]
    Correlation of visual function (visual acuity, contrast acuity and constrast acuity with glare)with glistening severity

  • Visual quality [ Time Frame: Post-operative ] [ Designated as safety issue: No ]
    Correlation of visual quality (measured with quality of life questionnaire, and subjective reports of symptoms) with glistening severity


Estimated Enrollment: 400
Study Start Date: July 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202981

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

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01202981     History of Changes
Other Study ID Numbers: 42093
Study First Received: September 14, 2010
Last Updated: June 20, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014