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Retinal Detachment - Demographic and Clinical Survey

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT01845571
Collaborator
(none)
400
Enrollment
1
Location
122
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Oct 1, 2011
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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 [2 years]

    2. Aqueous cytokine Levels [baseline]

    Secondary Outcome Measures

    1. OCT [baseline]

    2. Surgical Data [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Insitute of Ophthalmology and Optometry, Medical University of Vienna Vienna Austria 1090

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    • Principal Investigator: Stefan Sacu, Prof, Medical University of Vienna

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stefan Sacu, Ass.Prof.PD.Dr., Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT01845571
    Other Study ID Numbers:
    • 13.12.2011
    First Posted:
    May 3, 2013
    Last Update Posted:
    Mar 17, 2021
    Last Verified:
    Mar 1, 2021
    Additional relevant MeSH terms:
    Retinal Detachment
    Dissociative Disorders

    Study Results

    No Results Posted as of Mar 17, 2021