Retinopathy of PrematurityNCT00427063
Heredity of Retinal Vessel Tortuosity
An observational study of Retinopathy of Prematurity, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to asses the relative influence of genetic and environmental influence on the tortuosity of retinal arterioles in eyes of 218 healthy Danish twins aged 20-46 years. We expect to find a high heredity for the variation in tortuosity. Read more about this study
- Who is it for?
- Ages 20 to 46 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinopathy of Prematurity
- How many people
- 218 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 1998to Dec 1998
- 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 20 to 46 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Samesex twin pairs of self-assessed good health
Who cannot join
- Diabetes mellitus
- Hypertension
- Thyroid disease
- Cataract or other opacities of the refractive media
- Missing fundus photographs
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ophthalmology Glostrup Hospital
Glostrup Municipality, Copenhagen County, DK-2600
About this study
Official title: Heredity of Retinal Vessel Tortuosity - A Twin Study
The purpose of this study is to asses the relative influence of genetic and environmental influence on the tortuosity of retinal arterioles in eyes of 218 healthy Danish twins aged 20-46 years. We expect to find a high heredity for the variation in tortuosity. This knowledge can contribute to the elucidation of the pathology in retinal diseases.
Read the detailed description
All persons underwent an ophthalmic examination including refraction, slit lamp biomicroscopy and digital fundus photography. Two independent graders (both with an MD degree) made a visual grading of the severity of tortuosity of the retinal arterioles in the fundus images.
- Conditions
- Retinopathy of Prematurity
- Keywords
- retinal vessels, tortuosity
- Medical subject headings
- Retinopathy of Prematurity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2007 (estimated)
- Study startJan 1998
- Study completionDec 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies 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
- Defined population
- Time perspective
- Other
- Enrolment
- 218 participants
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Investigators
- Michael Larsen, Prof. MD, Principal investigator, Department of Ophthalmology Glostrup Hospital University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427063
- Sponsor's protocol ID
- Danish Twin Registry 1998
- Status last verified
- Jan 2007
- First submitted
- 25 Jan 2007
- Last updated
- 26 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heredity of Retinal Vessel Tortuosity - A Twin Study
- ClinicalTrials.gov ID
- NCT00427063
- Acronym / sponsor ID
- Danish Twin Registry 1998
- Conditions
- Retinopathy of Prematurity
- Keywords
- retinal vessels, tortuosity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Jan 1998
- Study completion
- Dec 1998
- First posted
- 26 Jan 2007 (estimated)
- 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.
The purpose of this study is to asses the relative influence of genetic and environmental influence on the tortuosity of retinal arterioles in eyes of 218 healthy Danish twins aged 20-46 years. We expect to find a high heredity for the variation in tortuosity. This knowledge can contribute to the elucidation of the pathology in retinal diseases.
Detailed description
All persons underwent an ophthalmic examination including refraction, slit lamp biomicroscopy and digital fundus photography. Two independent graders (both with an MD degree) made a visual grading of the severity of tortuosity of the retinal arterioles in the fundus images.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 46 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Samesex twin pairs of self-assessed good health
Key exclusion criteria (5 listed)
- Diabetes mellitus
- Hypertension
- Thyroid disease
- Cataract or other opacities of the refractive media
- Missing fundus photographs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2007.
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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.
Michael Larsen, Prof. MD principal investigator
Department of Ophthalmology Glostrup Hospital University of Copenhagen
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 Retinopathy of Prematurity, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 26 Jan 2007. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 26 Jan 2007.