Impact of Glistenings in AcrySof Intraocular Lenses on Vi... | NCT01202981

Studies
Impact of Glistenings in AcrySof Intraocular Lenses on Visual Quality

NCT01202981

Sponsor

University of Utah

Status

Completed

Last Update Posted

Dec 11, 2014Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Lenses, Intraocular
Glistenings
Visual Quality

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Jun 2013Actual

First Submitted Date

Sep 14, 2010

First Submission Date that Met QC Criteria

Sep 14, 2010

First Posted Date

Sep 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2014

Last Update Posted Date

Dec 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample