Association Between Light Spectrum and Survival After Cataract Surgery

December 3, 2019 updated by: Matthew Rosengart, University of Pittsburgh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC-Presbyterian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

November 26, 2019

First Submitted That Met QC Criteria

December 3, 2019

First Posted (Actual)

December 5, 2019

Study Record Updates

Last Update Posted (Actual)

December 5, 2019

Last Update Submitted That Met QC Criteria

December 3, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO18060034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared.

IPD Sharing Time Frame

Beginning12 months and ending 36 months after publication.

IPD Sharing Access Criteria

Data will be shared with researchers who provide a methodologically sound proposal.

Analyses are limited to those to achieve the aims listed in the approval proposal.

Proposals should be directed to mrr18@pitt.edu; to gain access, data requestors will need to sign a data access agreement.

Information regarding accessing data may be obtained after approval of the proposal.

IPD Sharing Supporting Information Type

  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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