Impact of Glistenings in AcrySof Intraocular Lenses on Visual Quality

Lenses, Intraocular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202981
• Other study ID #: 42093
• Status: Completed
• Phase: N/A
• First received: September 14, 2010
• Last updated: December 9, 2014
• Start date: July 2010
• Est. completion date: June 2013

Study information

• Verified date: December 2014
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glistenings
• Lenses, Intraocular
• Visual Quality

Locations

Country	Name	City	State
United States	University of Utah, John Moran Eye Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Light scattering	Correlation of random light scattering (measured with the C-Quant device) with severity of glistenings in the lenses	Post-opertative	No
Secondary	Visual function	Correlation of visual function (visual acuity, contrast acuity and constrast acuity with glare)with glistening severity	Post-operative	No
Secondary	Visual quality	Correlation of visual quality (measured with quality of life questionnaire, and subjective reports of symptoms) with glistening severity	Post-operative	No