Impact of Glistenings in AcrySof Intraocular Lenses on Visual Quality

NCT ID: NCT01202981

Last Updated: 2014-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Lenses, Intraocular Glistenings Visual Quality

Keywords

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glistenings contrast sensitivity visual quality straylight AcrySof IOL

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

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

No interventions assigned to this group

Group 2

Patients who had cataract surgery by the Investigators between July 1, 2008 and July 1, 2009.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Randall J Olson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah, John Moran Eye Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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42093

Identifier Type: -

Identifier Source: org_study_id