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Trial record 2 of 4 for:    cytokines | retinal detachment

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 : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Stefan Sacu, Medical University of Vienna

Tracking Information
First Submitted Date January 11, 2012
First Posted Date May 3, 2013
Last Update Posted Date March 17, 2021
Study Start Date October 2011
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 30, 2013)
  • Vision [ Time Frame: 2 years ]
  • Aqueous cytokine Levels [ Time Frame: baseline ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 30, 2013)
  • OCT [ Time Frame: baseline ]
  • Surgical Data [ Time Frame: 2 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Retinal Detachment - Demographic and Clinical Survey
Official Title Long-term Anatomic and Funcional Succes After Surgery in Eyes With Retinal Detachment
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
vitreous body samples and blood plasmsa for evaluation of cytocines levels.
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.
Condition Rhegmatogenous Retinal Detachment
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 30, 2013)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT01845571
Other Study ID Numbers 13.12.2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stefan Sacu, Medical University of Vienna
Study Sponsor Medical University of Vienna
Collaborators Not Provided
Investigators
Principal Investigator: Stefan Sacu, Prof Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date March 2021