Association Between Light Spectrum and Survival After Cataract Surgery

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT04187157

Collaborator

(none)

10,192

Enrollment

Location

87.9

Actual Duration (Months)

115.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was a retrospective observational cohort analysis of subjects aged 65 years and older, who underwent bilateral cataract surgery within a single (15 hospital) healthcare system, to determine the association between type (conventional or blue-light filtering) of implanted intraocular lens and survival.

Condition or Disease	Intervention/Treatment	Phase
Cataract Age-related Cataract Circadian Rhythm Disorders Glaucoma Age Related Macular Degeneration	Device: Blue-light filtering intraocular lens Device: Conventional intraocular lens

Study Design

Study Type:

Observational

Actual Enrollment :

10192 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Association Between the Implantation of Conventional or Blue Light-filtering Intraocular Lens and Survival Among Patients Undergoing Bilateral Cataract Surgery: a Multi-center, Observational Cohort Study

Actual Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Apr 30, 2019

Actual Study Completion Date :

Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Blue-light filtering intraocular lens (IOL) Bilateral implantation of blue-filtering intraocular lens. Blue-IOL, in addition to ultraviolet, also impede the transmission of the lower visible blue spectrum between 400 and 500nm.	Device: Blue-light filtering intraocular lens Bilateral implantation of blue light-blocking intraocular lens
Conventional intraocular lens (IOL) Bilateral implantation of conventional ultraviolet light-blocking intraocular lens	Device: Conventional intraocular lens Bilateral implantation of conventional intraocular lens

Arm

Intervention/Treatment

Blue-light filtering intraocular lens (IOL)

Bilateral implantation of blue-filtering intraocular lens. Blue-IOL, in addition to ultraviolet, also impede the transmission of the lower visible blue spectrum between 400 and 500nm.

Device: Blue-light filtering intraocular lens

Bilateral implantation of blue light-blocking intraocular lens

Conventional intraocular lens (IOL)

Bilateral implantation of conventional ultraviolet light-blocking intraocular lens

Device: Conventional intraocular lens

Bilateral implantation of conventional intraocular lens

Outcome Measures

Primary Outcome Measures

All-cause mortality [From the date of the initial cataract surgery until the date of death or end of the study period (April 30, 2019), whichever occurred first, assessed up to 2,310 days.]
The primary outcome was all-cause mortality. Mortality was identified based on the Social Security Death Master File and discharge status. Follow-up started from the day after the initial surgery until the end of the study period or death, whichever occurred first. Time to death was calculated as the number of days from the first cataract surgery to death. Participants who did not have a recorded death were censored on April 30, 2019.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The study population consisted of all adult patients (at least 65 years) who underwent bilateral cataract surgery between January 01, 2012 and January 01, 2018 within the University of Pittsburgh Medical Center (UPMC) healthcare system. To be considered bilateral and concomitant, cataract surgery had to be performed on both the left and the right eye within a 365-day period.

Exclusion Criteria:

We excluded patients undergoing unilateral cataract surgery, surgery to replace or repair a previously implanted IOL, or bilateral implantation with one Blue-IOL and one Natural-IOL (i.e., mixed IOL transmission properties).