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Completed

NCT Number: NCT01202981

Impact of Glistenings in AcrySof Intraocular Lenses on Visual Quality

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).

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Key information

Conditions

Lenses, Intraocular Glistenings Visual Quality

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah, John Moran Eye Center

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any central corneal pathology that could have impact on vision other than mild guttata felt unlikely to have any impact on corneal clarity.
  • Any documented glaucoma of any kind.
  • Any macular pathology except minimal drusen without retinal pigment epithelial pathology felt to be consistent with normal vision.
  • Any diabetic retinopathy other than minimal background diabetic retinopathy felt unlikely to affect vision.
  • Any other cause of central visual acuity loss including optic nerve, occipital cortex dysfunction or amblyopia.
  • Diagnosis of dry eye syndrome, defined as any corneal staining with fluorescein
  • Presence of any central posterior capsular opacification. Previous YAG laser capsulotomy is allowed.
  • 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.
  • Any contraindication to pupil dilation

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Sep 16, 2010
Registry last updated
Dec 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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