Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling

Completed

• Conditions: Macular Edema, Cystoid

• Registration Number: NCT04472039
• Lead Sponsor: Vienna Institute for Research in Ocular Surgery

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-06-30
• Study First Submitted: 2020-07-11
• Study First Submitted QC: 2020-07-11
• Study First Posted: 2020-07-15
• Status Verified: 2020-09
• Primary Completion: 2020-09-28
• Study Completion: 2020-09-28
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraretinal cystoid changes	3 months	presence of intraretinal cystoid changes in OCT is assessed during the time period of 3 months after surgery

Secondary Outcome Measures

Name	Time	Method
intraocular pressure (IOP)	3 months	intraocular pressure is examined during the time period of 3 months after surgery
distance corrected visual acuity	3 months	distance corrected visual acuity is measured at baseline and 3 months after surgery

Trial Locations

Locations (1)

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna; 🇦🇹 Vienna, Austria