NCT02367677

Brief Summary

To compare measurements made by a computer software (ImageJ) made on photographs to the traditional clinical measures with a ruler in the evaluation of blepharoptosis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Typical duration for all trials

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

Study Start

First participant enrolled

November 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
Last Updated

February 2, 2017

Status Verified

August 1, 2016

Enrollment Period

3.1 years

First QC Date

February 3, 2015

Last Update Submit

February 1, 2017

Conditions

Blepharoptosis

Keywords

Photo

Outcome Measures

Primary Outcomes (2)

  • Reliability of measurements made on photographs to evaluate blepharoptosis

    Comparison between measurements made on digital photographs with measurements made with a ruler in clinic

    Same day

  • Reliability of measurements made on photographs taken by smartphone to evaluate blepharoptosis

    Comparison between measurements made on digital photographs taken by smartphone with measurements made on digital photographs taken with a digital camera

    Same day

Study Arms (3)

Clinical measurements

Measurements are made with a paper ruler

Other: Method comparison

Smartphone

Measurements are made with ImageJ from pictures taken with an iPhone 6

Other: Method comparison

Digital camera

Measurements are made with ImageJ from pictures taken with a Nikon D700

Other: Method comparison

Interventions

Method comparisonOTHER
Clinical measurementsDigital cameraSmartphone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ptosis of all causes

You may qualify if:

  • Patients 18 years old or older

You may not qualify if:

  • Myasthenia gravis
  • Thyroid eye disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Universitaire d'Ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec

Québec, Quebec, G1S 4L8, Canada

Location

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Study Officials

  • Yvonne Molgat, MDCM, FRCSC

    Centre de recherche du CHU de Québec : Université Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 20, 2015

Study Start

November 1, 2013

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

February 2, 2017

Record last verified: 2016-08

Locations

CA(1)