Retinal Detachment - Demographic and Clinical Survey

• ClinicalTrials.gov Identifier: NCT01845571
• Recruitment Status: Recruiting
• First Posted: May 3, 2013
• Last Update Posted: March 17, 2021
• Sponsor: Medical University of Vienna
• 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

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

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
• Listed Location Countries: Austria

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