Dry EyeEPISTA1NCT04458012
Epidemiological Study of Dry Eye Disease in Stavanger: Dry Eye Disease in Patients Treated With Intravitreal Injections
An observational study of Dry Eye, run by Helse Stavanger HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- Oculus Keratograph. Schirmer test. Tear fluid sample.
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- 25 Jun 2020to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with age related macular degeneration receiving intravitreal injections with anti-vegf.
Who may be able to join
- AMD diagnosis
- Treated with intravitreal injection agents
Who cannot join
- Not able to cooperate
Trial locations and contacts
1 site in 1 country.
Norway1 site
Stavanger University Hospital, Department of Ophthalmology
Stavanger, 4068
About this study
Official title: 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.
Read the 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.
- Conditions
- Dry Eye
- Being tested
- Oculus Keratograph. Schirmer test. Tear fluid sample.
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Dry eye disease in patients receiving intravitreal injections
Measured: 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start25 Jun 2020
- Primary completion25 Jun 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Tor Paaske Utheim, Vegard Asgeir Forsaa, Vilde Marie Thomseth
- Responsible party
- Principal investigator, Agni Malmin, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458012
- Sponsor's protocol ID
- EPISTA1
- Acronym
- EPISTA1
- Status last verified
- Jun 2020
- First submitted
- 30 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malmin A, Olsen MVT, Thomseth VM, Kjellevold Haugen IB, Utheim TP, Forsaa VA. Long-term Impact of Intravitreal Injections on the ocular surface; a 2-year follow-up study. Front Ophthalmol (Lausanne). 2026 Jul 17;6:1829818. doi: 10.3389/fopht.2026.1829818. eCollection 2026.
PubMed 42539849
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of Dry Eye Disease in Stavanger: Dry Eye Disease in Patients With Age-related Macular Degeneration Treated With Intravitreal Injections
- ClinicalTrials.gov ID
- NCT04458012
- Acronym / sponsor ID
- EPISTA1 / EPISTA1
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Tor Paaske Utheim, Vegard Asgeir Forsaa, Vilde Marie Thomseth
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 25 Jun 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with age related macular degeneration receiving intravitreal injections with anti-vegf.
Key inclusion criteria (2 listed)
- AMD diagnosis
- Treated with intravitreal injection agents
Key exclusion criteria (1 listed)
- Not able to cooperate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oculus Keratograph. Schirmer test. Tear fluid sample.Objective measurements of the ocular surface using Oculus 5 keratograph. Slit lamp examination and tear fluid sample using Schirmer strips. | Diagnostic test | – |
Primary outcome
Dry eye disease in patients receiving intravitreal injections
Time frame: 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 42539849Malmin A, Olsen MVT, Thomseth VM, Kjellevold Haugen IB, Utheim TP, Forsaa VA. Long-term Impact of Intravitreal Injections on the ocular surface; a 2-year follow-up study. Front Ophthalmol (Lausanne). 2026 Jul 17;6:1829818. doi: 10.3389/fopht.2026.1829818. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dry eye disease in patients receiving intravitreal injections (time frame: 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04458012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.