RetinoschisisNCT02682797
Optical Coherence Tomography Evaluation of Retinoschisis and Retinal Detachment
An observational study of Retinoschisis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Retinoschisis is usually a rare self-limited disease and seldom shows progression. There a splitting of the neurosensory retina occurs usually in the inferior temporal. Patients usually have good visual acuity and are asymptomatic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinoschisis
- How many people
- 44 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2013to Jul 2016
- 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: 30 consecutive patients will be recruited for this study; 15 with Retinoschisis and 15 with retinal detachment
Who may be able to join
- Male or female, at least 18 years of age.
- Ophthalmoscopic evidence of RS or RD
- Written informed consent has been obtained.
Who cannot join
- Progression of retinal detachment or retinoschisis requiring surgical treatment
- Contraindication to pupil dilation, known allergy.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Ophthalmology, Medical University of Vienna, Austria
Vienna, State of Vienna, 1090
About this study
Official title: Use of Spectral Domain Optical Coherence Tomography to Differentiate and Follow-up Senile Retinoschisis and Retinal Detachment
Retinoschisis is usually a rare self-limited disease and seldom shows progression. There a splitting of the neurosensory retina occurs usually in the inferior temporal. Patients usually have good visual acuity and are asymptomatic. Combination of an inner and outer layer hole is considered high risk factor for development of a schisis detachment. The most important differential diagnosis is an retinal detachment, since if misdiagnosed unnecessary treatment is provided. In clinical examination, both can appear very thin and transparent.
Therefore exact diagnosis of retinoschisis and retinal detachment has to be assessed and regular follow-up controls have to be conducted for sufficient recognition of progression.
- Conditions
- Retinoschisis
- Medical subject headings
- Retinoschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | At all study visits a complete ophthalmic examination, visual acuity and refractive error, Spectralis OCT, Cirrus OCT, Topcon OCT, PS-OCT, Optomap Fundus photography will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphological findings in retinoschisis or retinal detachment in optical coherence tomography scans during follow-up
Measured: Baseline
Change or progression of disease measured in optical coherence tomography
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startSep 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinoschisisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Sacu, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682797
- Sponsor's protocol ID
- 19.08.2015
- Status last verified
- Aug 2016
- First submitted
- 5 Feb 2016
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Spectral Domain Optical Coherence Tomography to Differentiate and Follow-up Senile Retinoschisis and Retinal Detachment
- ClinicalTrials.gov ID
- NCT02682797
- Acronym / sponsor ID
- 19.08.2015
- Conditions
- Retinoschisis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 15 Feb 2016 (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.
Retinoschisis is usually a rare self-limited disease and seldom shows progression. There a splitting of the neurosensory retina occurs usually in the inferior temporal. Patients usually have good visual acuity and are asymptomatic. Combination of an inner and outer layer hole is considered high risk factor for development of a schisis detachment. The most important differential diagnosis is an retinal detachment, since if misdiagnosed unnecessary treatment is provided. In clinical examination, both can appear very thin and transparent.
Therefore exact diagnosis of retinoschisis and retinal detachment has to be assessed and regular follow-up controls have to be conducted for sufficient recognition of progression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –At all study visits a complete ophthalmic examination, visual acuity and refractive error, Spectralis OCT, Cirrus OCT, Topcon OCT, PS-OCT, Optomap Fundus photography will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 consecutive patients will be recruited for this study; 15 with Retinoschisis and 15 with retinal detachment
Key inclusion criteria (3 listed)
- Male or female, at least 18 years of age.
- Ophthalmoscopic evidence of RS or RD
- Written informed consent has been obtained.
Key exclusion criteria (2 listed)
- Progression of retinal detachment or retinoschisis requiring surgical treatment
- Contraindication to pupil dilation, known allergy.
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
Morphological findings in retinoschisis or retinal detachment in optical coherence tomography scans during follow-up
Time frame: Baseline
Change or progression of disease measured in optical coherence tomography
Time frame: 2 years
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 8 Aug 2016.
- 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 Retinoschisis, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 2 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 8 Aug 2016. 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 Austria. 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?
Morphological findings in retinoschisis or retinal detachment in optical coherence tomography scans during follow-up (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 8 Aug 2016.