CataractNCT04187157
Association Between Light Spectrum and Survival After Cataract Surgery
An observational study of Cataract and Age-related Cataract, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cataract, Age-related Cataract, Circadian Rhythm Disorders
- What is being tested?
- Blue-light filtering intraocular lens and Conventional intraocular lens
- Type of treatment
- Medical device
- How many people
- 10,192 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2012to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
About this study
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
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.
- Conditions
- Cataract, Age-related Cataract, Circadian Rhythm Disorders, Glaucoma, Age Related Macular Degeneration
- Being tested
- Blue-light filtering intraocular lens, Conventional intraocular lens
- Keywords
- circadian, cataracts, blue light, survival
- Medical subject headings
- Cataract, Chronobiology Disorders, Glaucoma, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue-light filtering intraocular lensDevice
Bilateral implantation of blue light-blocking intraocular lens
Conventional intraocular lensDevice
Bilateral implantation of conventional intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Blue-light filtering intraocular lens | |
| Conventional intraocular lens (IOL) | Bilateral implantation of conventional ultraviolet light-blocking intraocular lens Receives: Device: Conventional intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Jan 2012
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Rosengart, University of Pittsburgh
- Investigators
- Matthew R Rosengart, MD MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187157
- Sponsor's protocol ID
- PRO18060034
- Status last verified
- Dec 2019
- First submitted
- 26 Nov 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04187157
- Acronym / sponsor ID
- PRO18060034
- Conditions
- Cataract, Age-related Cataract, Circadian Rhythm Disorders, Glaucoma, Age Related Macular Degeneration
- Keywords
- circadian, cataracts, blue light, survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,192 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blue-light filtering intraocular lens (IOL) | – | Device: Blue-light filtering intraocular lensBilateral 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. |
| Conventional intraocular lens (IOL) | – | Device: Conventional intraocular lensBilateral implantation of conventional ultraviolet light-blocking intraocular lens |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue-light filtering intraocular lensBilateral implantation of blue light-blocking intraocular lens | Device | Blue-light filtering intraocular lens (IOL) |
| Conventional intraocular lensBilateral implantation of conventional intraocular lens | Device | Conventional intraocular lens (IOL) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew R Rosengart, MD MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Age-related Cataract, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.