Impact of Glistenings in AcrySof Intraocular Lenses on Visual Quality

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Glistenings; Visual Quality; Lenses, Intraocular

Study type: Observational

Funder types: Other

Identifiers

NCT01202981

42093

Details and patient eligibility

About

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).

Enrollment: 200 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Group 1

Description:

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

Group 2

Description:

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