Retinal Detachment - Demographic and Clinical Survey

March 14, 2023 updated by: Stefan Sacu, Medical University of Vienna

Long-term Anatomic and Funcional Succes After Surgery in Eyes With Retinal Detachment

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Insitute of Ophthalmology and Optometry, Medical University of Vienna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vision
Time Frame: 2 years
2 years
Aqueous cytokine Levels
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
OCT
Time Frame: baseline
baseline
Surgical Data
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

April 30, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13.12.2011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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