- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02682797
Optical Coherence Tomography Evaluation of Retinoschisis and Retinal Detachment
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1090
- Department of Ophthalmology, Medical University of Vienna, Austria
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female, at least 18 years of age.
- Ophthalmoscopic evidence of RS or RD
- Written informed consent has been obtained.
Exclusion Criteria:
- Progression of retinal detachment or retinoschisis requiring surgical treatment
- Contraindication to pupil dilation, known allergy.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Morphological findings in retinoschisis or retinal detachment in optical coherence tomography scans during follow-up
Time Frame: Baseline
|
Baseline
|
Change or progression of disease measured in optical coherence tomography
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19.08.2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Retinoschisis
-
National Eye Institute (NEI)Recruiting
-
Applied Genetic Technologies CorpCompletedX-linked RetinoschisisUnited States
-
Aier School of Ophthalmology, Central South UniversityUnknownRetinal Disease | Macular RetinoschisisChina
-
Zhongmou TherapeuticsRecruitingX-linked RetinoschisisChina
-
Shanghai General Hospital, Shanghai Jiao Tong University...Innostellar BiotherapeuticsRecruitingX-linked RetinoschisisChina
-
National Eye Institute (NEI)Active, not recruiting
-
Atsena Therapeutics Inc.RecruitingX-linked RetinoschisisUnited States
-
Applied Genetic Technologies CorpFoundation Fighting BlindnessCompletedX-linked Retinoschisis | XLRSUnited States
-
National Eye Institute (NEI)CompletedRetinoschisis | X-LinkedUnited States
-
Kyorin UniversityCompletedMacular Retinoschisis | Macular Detachment | Intrachoroidal CavitationJapan