Epidemiological Study of Dry Eye Disease in Stavanger: Dry Eye Disease in Patients Treated With Intravitreal Injections (EPISTA1)

July 2, 2020 updated by: Agni Malmin, Helse Stavanger HF

Epidemiological Study of Dry Eye Disease in Stavanger: Dry Eye Disease in Patients With Age-related Macular Degeneration Treated With Intravitreal Injections

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Questionaires (OSDI, McMonnies) and clinical investigation using the Oculus 5 Keratograph for objective ocular surface evaluation. Tear fluid samples will be collected for later biochemical analysis.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Stavanger, Norway, 4068
        • Stavanger University Hospital, Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • AMD diagnosis
  • Treated with intravitreal injection agents

Exclusion Criteria:

  • Not able to cooperate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dry eye disease in patients receiving intravitreal injections
Time Frame: 2022
2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Collaborators

Tor Paaske Utheim
Vegard Asgeir Forsaa
Vilde Marie Thomseth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 25, 2020

Primary Completion (ANTICIPATED)

June 25, 2023

Study Completion (ANTICIPATED)

June 1, 2024

Study Registration Dates

First Submitted

June 30, 2020

First Submitted That Met QC Criteria

July 2, 2020

First Posted (ACTUAL)

July 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 2, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPISTA1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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