NCT04458012

Brief Summary

To investigate prevalence of dry eye disease in Norwegian patients with age-related macular degeneration receiving intravitreal injections, as well as to reveal possible risk factors of DED in this population.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 25, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 7, 2020

Status Verified

June 1, 2020

Enrollment Period

3 years

First QC Date

June 30, 2020

Last Update Submit

July 2, 2020

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Dry eye disease in patients receiving intravitreal injections

    2022

Interventions

Oculus Keratograph. Schirmer test. Tear fluid sample.DIAGNOSTIC_TEST

Objective measurements of the ocular surface using Oculus 5 keratograph. Slit lamp examination and tear fluid sample using Schirmer strips.

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with age related macular degeneration receiving intravitreal injections with anti-vegf.

You may qualify if:

  • AMD diagnosis
  • Treated with intravitreal injection agents

You may not qualify if:

  • Not able to cooperate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital, Department of Ophthalmology

Stavanger, 4068, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tear fluid

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 7, 2020

Study Start

June 25, 2020

Primary Completion

June 25, 2023

Study Completion

June 1, 2024

Last Updated

July 7, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)