NCT01845571

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2012

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

12.2 years

First QC Date

January 11, 2012

Last Update Submit

March 14, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Vision

    2 years

  • Aqueous cytokine Levels

    baseline

Secondary Outcomes (2)

  • OCT

    baseline

  • Surgical Data

    2 years

Study Arms (1)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • If patients had prior vitrectomy or scleral buckel. If patients had no adequate follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Insitute of Ophthalmology and Optometry, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

Study Officials

  • Stefan Sacu, Prof

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.PD.Dr.

Study Record Dates

First Submitted

January 11, 2012

First Posted

May 3, 2013

Study Start

October 1, 2011

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 15, 2023

Record last verified: 2023-03

Locations