Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling

Macular Edema, Cystoid Clinical Trial

Official title:

Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04472039
• Other study ID #: RAC
• Status: Completed
• Start date: June 30, 2020
• Est. completion date: September 28, 2020

Study information

• Verified date: September 2020
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aim of the study is to assess the rate of postoperative intraretinal cystoid changes after pars plana vitrectomy with membrane peeling and peribulbar application of triamcinolone acetonide and to examine possible risk factors for postoperative intraretinal cystoid changes.

Description:

Epiretinal membranes (ERM) are disorders leading to vision loss and metamorphopsia. Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of ERM. Nevertheless, there are about 10% of patients having intraretinal cystoid changes after surgery with potential for disturbance of visual acuity. The aim of the study is to assess the rate of postoperative intraretinal cystoid changes after pars plana vitrectomy with membrane peeling and peribulbar application of triamcinolone acetonide and to examine possible risk factors for postoperative intraretinal cystoid changes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 28, 2020
• Est. primary completion date: September 28, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• presence of an ERM

• indication for membrane peeling defined as significant loss of vision and/or metamorphopsia due to the ERM

• application of periocular triamcinolone acetonide at the end of surgery

• at least one follow-up examination present in the patient's history

Exclusion Criteria:

• macular edema caused by conditions other than ERM (such as choroidal neovascularization, diabetic macular edema, etc.)

Related Conditions & MeSH terms

• Macular Edema
• Macular Edema, Cystoid

Intervention

Device:
• optical coherence tomography (OCT)
OCT visualizes the retinal layers by backreflection of light

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraretinal cystoid changes	presence of intraretinal cystoid changes in OCT is assessed during the time period of 3 months after surgery	3 months
Secondary	intraocular pressure (IOP)	intraocular pressure is examined during the time period of 3 months after surgery	3 months
Secondary	distance corrected visual acuity	distance corrected visual acuity is measured at baseline and 3 months after surgery	3 months