Optical Coherence Tomography Evaluation of Retinoschisis and Retinal Detachment

August 5, 2016 updated by: Stefan Sacu, Medical University of Vienna

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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vienna, Austria, 1090
        • Department of Ophthalmology, Medical University of Vienna, Austria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

February 5, 2016

First Submitted That Met QC Criteria

February 12, 2016

First Posted (Estimate)

February 15, 2016

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 5, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 19.08.2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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