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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01845571
Other study ID # 13.12.2011
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2011
Est. completion date December 2023

Study information

Verified date March 2023
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Insitute of Ophthalmology and Optometry, Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vision 2 years
Primary Aqueous cytokine Levels baseline
Secondary OCT baseline
Secondary Surgical Data 2 years
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