NCT03030729

Brief Summary

Comparison between retinal measurements, done by the RT (Retinal Thickness) imaging and a commercial OCT (Optical Coherence Tomography)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 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

First Submitted

Initial submission to the registry

January 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 14, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2018

Completed
Last Updated

June 17, 2019

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

January 23, 2017

Last Update Submit

June 13, 2019

Conditions

Age-Related Macular DegenerationDiabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • Comparison between retinal measurements, done by the RTOCT device and a commercial OCT

    1 year

Study Arms (4)

Intermediate AMD

Advanced AMD

DR without macular edema

DR with macular edema

Eligibility Criteria

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

1. AMD population - intermediate and advanced AMD (with active and non-active CNV) 2. DR population. Patient with and without DME

You may qualify if:

  • Ability and agreement to give informed consent (IC)
  • Diagnosis of AMD or DR in SE by OCT
  • Ability to undergo OCT scans

You may not qualify if:

  • AMD and DR in the same SE
  • Evidence of macular disease other than AMD or DME in SE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sorasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Macular DegenerationDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

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

Study Record Dates

First Submitted

January 23, 2017

First Posted

January 25, 2017

Study Start

March 14, 2017

Primary Completion

January 14, 2018

Study Completion

January 14, 2018

Last Updated

June 17, 2019

Record last verified: 2017-01

Locations

IL(1)