Retinal DetachmentNCT03187613
Correlation of Metamorphopsia and Aniseikonia to Retinal Shift Following Retinal Detachment Surgery
An observational study of Retinal Detachment, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
Individuals operated for rhegmatogenous retinal detachment will be prospectively evaluated for postoperative retinal shift. Fundus autofluorescence will be used to evaluate retinal shift that will be correlated to visual acuity, metamorphopsia, aniseikonia, and stereopsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- How many people
- 38 participants
- Where
- 1 siteNorway
- Study dates
- 21 Jun 2017to 31 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals treated at Stavanger University Hospital
Who may be able to join
- Acute rhegmatogenous retinal detachment, fovea detached, able to signe
Who cannot join
- Secondary retinal detachment like tractional, serous or with ora serrata dialysis, fovea on
Trial locations and contacts
1 site in 1 country.
Norway1 site
Stavanger University Hospital, Department of Ophthalmology
Stavanger, 4016
About this study
Individuals operated for rhegmatogenous retinal detachment will be prospectively evaluated for postoperative retinal shift. Fundus autofluorescence will be used to evaluate retinal shift that will be correlated to visual acuity, metamorphopsia, aniseikonia, and stereopsis.
- Conditions
- Retinal Detachment
- Keywords
- Retinal shift, Aniseikonia, Metamorphopsia, Autofluorescence
- Medical subject headings
- Retinal Detachment, Aniseikonia, Vision Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal shift
Measured on fundus autofluorescence
Measured: 2 years
Secondary outcomes (4)
Visual acuity
Best Corrected Visual Acuity
Measured: 6 and 24 months
Metamorphopsia
M-Chart
Measured: 6 and 24 months
Aniseikonia
New Aniseikonia Test
Measured: 6 and 24 months
Stereopsis
Titmus Test
Measured: 6 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start21 Jun 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Vegard Forsaa, MD, Study director, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187613
- Sponsor's protocol ID
- 2017/730 REK
- Status last verified
- Oct 2020
- First submitted
- 13 Jun 2017
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thomseth VM, Lindtjorn B, Ushakova A, Forsaa VA. LONG-TERM CHANGES IN VISUAL FUNCTION AND EN FACE OPTICAL COHERENCE TOMOGRAPHY FINDINGS IN FOVEA-OFF RETINAL DETACHMENT: A 2-Year Prospective Study. Retina. 2023 Feb 1;43(2):330-337. doi: 10.1097/IAE.0000000000003670.
PubMed 36695802Thomseth VM, Ushakova A, Krohn J, Utheim TP, Austeng D, Fossen K, Varhaug P, Malmin A, Skeiseid L, Tharaldsen A, Lindtjorn B, Johannesen H, Juul J, Forsaa VA. STRUCTURAL PATHOLOGY AFTER RETINAL DETACHMENT: Multicolor Confocal Scanning Laser Ophthalmoscopy Versus Color Fundus Photography. Retina. 2021 Sep 1;41(9):1958-1965. doi: 10.1097/IAE.0000000000003113.
PubMed 33464027Thomseth VM, Engelsvold DH, Ushakova A, Forsaa VA. EN FACE IMAGING OF OUTER RETINAL PATHOLOGY AFTER RETINAL DETACHMENT. Retina. 2021 Feb 1;41(2):324-330. doi: 10.1097/IAE.0000000000002814.
PubMed 32282661
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Metamorphopsia and Aniseikonia to Retinal Shift Following Retinal Detachment Surgery
- ClinicalTrials.gov ID
- NCT03187613
- Acronym / sponsor ID
- 2017/730 REK
- Conditions
- Retinal Detachment
- Keywords
- Retinal shift, Aniseikonia, Metamorphopsia, Autofluorescence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 Jun 2017 (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.
Individuals operated for rhegmatogenous retinal detachment will be prospectively evaluated for postoperative retinal shift. Fundus autofluorescence will be used to evaluate retinal shift that will be correlated to visual acuity, metamorphopsia, aniseikonia, and stereopsis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals treated at Stavanger University Hospital
Key inclusion criteria (1 listed)
- Acute rhegmatogenous retinal detachment, fovea detached, able to signe
Key exclusion criteria (1 listed)
- Secondary retinal detachment like tractional, serous or with ora serrata dialysis, fovea on
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
Retinal shift
Time frame: 2 years
Measured on fundus autofluorescence
4 secondary outcomes
Visual acuity
Time frame: 6 and 24 months
Metamorphopsia
Time frame: 6 and 24 months
Aniseikonia
Time frame: 6 and 24 months
Stereopsis
Time frame: 6 and 24 months
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 28 Sep 2021.
- Derived from this study: PubMed 36695802Thomseth VM, Lindtjorn B, Ushakova A, Forsaa VA. LONG-TERM CHANGES IN VISUAL FUNCTION AND EN FACE OPTICAL COHERENCE TOMOGRAPHY FINDINGS IN FOVEA-OFF RETINAL DETACHMENT: A 2-Year Prospective Study. Retina. 2023 Feb 1;43(2):330-337. doi: 10.1097/IAE.0000000000003670.
- Derived from this study: PubMed 33464027Thomseth VM, Ushakova A, Krohn J, Utheim TP, Austeng D, Fossen K, Varhaug P, Malmin A, Skeiseid L, Tharaldsen A, Lindtjorn B, Johannesen H, Juul J, Forsaa VA. STRUCTURAL PATHOLOGY AFTER RETINAL DETACHMENT: Multicolor Confocal Scanning Laser Ophthalmoscopy Versus Color Fundus Photography. Retina. 2021 Sep 1;41(9):1958-1965. doi: 10.1097/IAE.0000000000003113.
- Derived from this study: PubMed 32282661Thomseth VM, Engelsvold DH, Ushakova A, Forsaa VA. EN FACE IMAGING OF OUTER RETINAL PATHOLOGY AFTER RETINAL DETACHMENT. Retina. 2021 Feb 1;41(2):324-330. doi: 10.1097/IAE.0000000000002814.
- Individual participant dataSharing planned: Undecided
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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.
Vegard Forsaa, MD study director
Helse Stavanger HF
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 Retinal Detachment, 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 1 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: finished, as of the sponsor's last update on 28 Sep 2021. 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?
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.
What does the primary outcome measure?
Retinal shift (time frame: 2 years). 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 NCT03187613, which also lists 3 linked publications.
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 28 Sep 2021.