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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02682797
Other study ID # 19.08.2015
Secondary ID
Status Completed
Phase N/A
First received February 5, 2016
Last updated August 5, 2016
Start date September 2013
Est. completion date July 2016

Study information

Verified date August 2016
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Department of Ophthalmology, Medical University of Vienna, Austria Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Morphological findings in retinoschisis or retinal detachment in optical coherence tomography scans during follow-up Baseline No
Primary Change or progression of disease measured in optical coherence tomography 2 years No
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