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Retinal Detachment - Demographic and Clinical Survey

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ClinicalTrials.gov Identifier: NCT01845571
Recruitment Status : Recruiting
First Posted : May 3, 2013
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Background:

Rhegmatogenous retinal detachment is an ophthalmic emergency that, without surgical repair, often leads to blindness. The incidence is about 1/10000/year. The leading causes are myopia and aging which cause retinal tears often resulting in retinal detachment. Patients commonly experience photopsia, floaters, and peripheral visual field loss.

Two different general surgical treatment options exist for retinal detachment; scleral buckling or vitrectomy. However, the precise indications for each approach have not been well established. Correct classification of the retinal detachment is important. The first step is to decide whether an intra- or extra-ocular surgical approach is more appropriate. Simple rhegmatogenous retinal detachments are usually treated extraocularly with scleral buckling surgery, whereas more complicated cases require intraocular primary pars plana vitrectomy and one or more of gas, silicone oil, laser therapy, or cryotherapy.

Study objectives:

The purpose of this study is to evaluate different surgical techniques for the treatment of retinal detachment. Data relating to retinal status before treatment, surgical treatment, post-operative anatomy and visual acuity, post-operative OCT, and intra- and post-operative complications will be collected.

Vitreous cytokines will also be analyzed to monitor intravitreal inflammation as a result of retinal detachment.


Condition or disease
Rhegmatogenous Retinal Detachment

Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Long-term Anatomic and Funcional Succes After Surgery in Eyes With Retinal Detachment
Study Start Date : October 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Retinal detachment group
400 patients patients, who received surgery due to retinal detachment exclusion: if patients had prior vitrectomy or scleral buckel if patients have no adequate follow-up


Outcome Measures

Primary Outcome Measures :
  1. Vision [ Time Frame: 2 years ]
  2. Aqueous cytokine Levels [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. OCT [ Time Frame: baseline ]
  2. Surgical Data [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
vitreous body samples and blood plasmsa for evaluation of cytocines levels.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People will be selected from the surgery database of Ass.Prof.PD.Dr. Stefan Sacu and Prof. Dr. Michael Georgopoulos from the Medical University of Vienna.
Criteria

Inclusion Criteria:

Patients who received surgery due to retinal detachment between January 2008 and Decemebr 2012.

Surgery was performed by either Ass.Prof.PD.Dr. Stefan Sacu or Prof.Dr. Michael Georgopoulos

Exclusion Criteria:

If patients had prior vitrectomy or scleral buckel. If patients had no adequate follow-up.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845571


Locations
Austria
Insitute of Ophthalmology and Optometry, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Stefan Sacu, Prof    40400 - 7970    stefan.sacu@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Stefan Sacu, Prof Medical University of Vienna
More Information

Responsible Party: Stefan Sacu, Ass.Prof.PD.Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01845571     History of Changes
Other Study ID Numbers: 13.12.2011
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Dissociative Disorders
Retinal Detachment
Mental Disorders
Retinal Diseases
Eye Diseases