Retinal Detachment - Demographic and Clinical Survey

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Stefan Sacu, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01845571
First received: January 11, 2012
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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
Rhegmatogenous Retinal Detachment

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Long-term Anatomic and Funcional Succes After Surgery in Eyes With Retinal Detachment

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Vision [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Aqueous cytokine Levels [ Time Frame: baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • OCT [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Surgical Data [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

vitreous body samples and blood plasmsa for evaluation of cytocines levels.


Estimated Enrollment: 400
Study Start Date: October 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 11, 2012
Last Updated: January 2, 2014
Health Authority: Austria: Ethikkommission

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

ClinicalTrials.gov processed this record on August 28, 2014