Association Between Light Spectrum and Survival After Cataract Surgery

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04187157
• Other study ID #: PRO18060034
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: April 30, 2019

Study information

• Verified date: December 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10192
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Age-related Cataract
• Cataract
• Chronobiology Disorders
• Circadian Rhythm Disorders
• Glaucoma
• Macular Degeneration

Intervention

Device:
• Blue-light filtering intraocular lens
Bilateral implantation of blue light-blocking intraocular lens
• Conventional intraocular lens
Bilateral implantation of conventional intraocular lens

Locations

Country	Name	City	State
United States	UPMC-Presbyterian Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	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.