NCT03992586

Brief Summary

Decades of psychological research has highlighted the impact of visual perception on mood and happiness. The investigators hypothesized that literally seeing the world through rose colored glasses may have an effect on perception, mood, and happiness. After cataract surgery, which classically increases the vividness of perceived colors, patients report significant satisfaction. The investigators therefore sought to explore whether using pink colored lenses leads to a measurable impact on outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

August 30, 2018

Completed
10 months until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

10 months

First QC Date

August 14, 2018

Last Update Submit

August 21, 2020

Conditions

Mood

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Anxiety Scores on the Visual Analogue Scale at 1 week

    Scale range 0-100, higher values represent more anxiety

    1 week

Secondary Outcomes (3)

  • Change from baseline in Mood Scores on the Visual Analogue Scale

    1 week

  • Change from baseline in Happiness Scores on the Visual Analogue Scale

    1 week

  • Change from baseline in the Center for Epidemiological Studies Depression Scale score

    1 week

Study Arms (2)

Pink lenses

EXPERIMENTAL

Pink-colored lenses

Other: Wearing pink glasses

Clear lenses

PLACEBO COMPARATOR

Clear lenses

Other: Wearing clear glasses

Interventions

Wearing pink glassesOTHER

Wearing pink-colored lenses

Pink lenses
Wearing clear glassesOTHER

Wearing clear glasses

Clear lenses

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects over 18 years of age.

You may not qualify if:

  • Subjects who wear glasses on a regular basis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Vincent's Medical Center

Jacksonville, Florida, 32204, United States

Location

Study Officials

  • Jonathan Kantor, MD

    Florida Center for Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2018

First Posted

June 20, 2019

Study Start

August 30, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

August 25, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

Anonymized data are available to other researchers upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data are available to other researchers upon reasonable request.
Access Criteria
Data are available to other researchers upon reasonable request.

Locations

US(1)