Impact of Glistenings in AcrySof Intraocular Lenses on Visual Quality

December 9, 2014 updated by: University of Utah

Impact of IOL Glistenings on Visual Quality and Function in Patients Implanted With a Single-Piece AcrySof IOL That Exhibits Glistening Formation

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah, John Moran Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Light scattering
Time Frame: Post-opertative
Correlation of random light scattering (measured with the C-Quant device) with severity of glistenings in the lenses
Post-opertative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual function
Time Frame: Post-operative
Correlation of visual function (visual acuity, contrast acuity and constrast acuity with glare)with glistening severity
Post-operative
Visual quality
Time Frame: Post-operative
Correlation of visual quality (measured with quality of life questionnaire, and subjective reports of symptoms) with glistening severity
Post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Randall J Olson, MD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

September 14, 2010

First Posted (ESTIMATE)

September 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 9, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 42093

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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