NCT02682797

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

2.8 years

First QC Date

February 5, 2016

Last Update Submit

August 5, 2016

Conditions

Retinoschisis

Outcome Measures

Primary Outcomes (2)

  • Morphological findings in retinoschisis or retinal detachment in optical coherence tomography scans during follow-up

    Baseline

  • Change or progression of disease measured in optical coherence tomography

    2 years

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 consecutive patients will be recruited for this study; 15 with Retinoschisis and 15 with retinal detachment

You may qualify if:

  • Male or female, at least 18 years of age.
  • Ophthalmoscopic evidence of RS or RD
  • Written informed consent has been obtained.

You may not qualify if:

  • Progression of retinal detachment or retinoschisis requiring surgical treatment
  • Contraindication to pupil dilation, known allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Medical University of Vienna, Austria

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Retinoschisis

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. PD. Dr.

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 15, 2016

Study Start

September 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 8, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)