Impact of Glistenings in AcrySof Intraocular Lenses on Visual Quality

NCT01202981 | Completed

• 1 other identifier: 42093
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Lenses, Intraocular; Glistenings; Visual Quality

Keywords

glistenings; contrast sensitivity; visual quality; straylight; AcrySof IOL

Outcome Measures

Primary Outcomes (1)

• Light scattering

  Correlation of random light scattering (measured with the C-Quant device) with severity of glistenings in the lenses

  Post-opertative

Secondary Outcomes (2)

• Visual function

  Post-operative

• Visual quality

  Post-operative

Study Arms (2)

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 Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah, John Moran Eye Center

Salt Lake City, Utah, 84132, United States

Location

Study Officials

• Randall J Olson, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: December 11, 2014

Record last verified: 2014-12

Locations

US (1)