Impact of Glistenings in AcrySof Intraocular Lenses on Visual Quality

Completed

• Conditions: Visual Quality; Lenses, Intraocular; Glistenings

• Registration Number: NCT01202981
• Lead Sponsor: University of Utah

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-16
• Primary Completion: 2012-12
• Study Completion: 2013-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-09
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Light scattering	Post-opertative	Correlation of random light scattering (measured with the C-Quant device) with severity of glistenings in the lenses

Secondary Outcome Measures

Name	Time	Method
Visual function	Post-operative	Correlation of visual function (visual acuity, contrast acuity and constrast acuity with glare)with glistening severity
Visual quality	Post-operative	Correlation of visual quality (measured with quality of life questionnaire, and subjective reports of symptoms) with glistening severity

Trial Locations

Locations (1)

University of Utah, John Moran Eye Center; 🇺🇸 Salt Lake City, Utah, United States