New Postoperative Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling Due to Epiretinal Membranes

NCT06948851 | Active Not Recruiting

• 1 other identifier: ICC
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Epiretinal membranes (ERM) are a macular disorder leading to metamorphopsia and a decrease in visual acuity. Peeling of ERM during vitrectomy is, up to date, the only possible treatment option, opening chances for improvements of visual acuity and metamorphopsia. Occurrence of new intraretinal cystoid changes was described to be associated with a lower level of visual acuity after surgery, compared to patients, that never had intraretinal cystoid changes Aim of our study was to analyze development of new intraretinal cystoid changes after vitrectomy with membrane peeling with respect to postsurgical treatment strategies.

Conditions

Epiretinal Membrane

Outcome Measures

Primary Outcomes (1)

• new postoperative intraretinal cystoid changes

  presence of new postoperative intraretinal cystoid changes is assessed from OCT images 3 months after surgery

  3 months after surgery

Secondary Outcomes (1)

• Maximum diameter of postoperative intraretinal cystoid changes

  3 months after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients having undergone pars plana vitrectomy with membrane peeling with application of periocular triamcinolone acetonide and a prolonged application of steroidal eye drops after surgery for at least 3 months. To examine differences in development of new postoperative cystoid changes outcomes will be compared with a historical group of patients, that did not receive periocular triamcinolone acetonide and had a postoperative application of steroidal eye drops for one month.

You may qualify if:

• presence of an idiopathic ERM with decrease in visual acuity affecting activities of the daily life
• undergone pars plana vitrectomy with membrane peeling with application of periocular triamcinolone acetonide and a prolonged application of steroidal eye drops for three months after surgery, performed by a single surgeon in the time period from 01/08/2020 to 31/05/2023.
• presence of a follow-up examination at our department three months after surgery (+-1 month), including OCT with accurate image quality for analyzing the presence or absence of intraretinal cystoid changes and visual acuity testing.
• age of 18 years of older.

You may not qualify if:

• age below 18 years

Sponsors & Collaborators

• Prim. Prof. Dr. Oliver Findl, MBA: lead

Study Sites (1)

Vienna Institute for Research in Ocular Surgery

Vienna, 1040, Austria

Location

Related Publications (5)

• Mitchell P, Smith W, Chey T, Wang JJ, Chang A. Prevalence and associations of epiretinal membranes. The Blue Mountains Eye Study, Australia. Ophthalmology. 1997 Jun;104(6):1033-40. doi: 10.1016/s0161-6420(97)30190-0.

  PMID: 9186446 BACKGROUND

• Bu SC, Kuijer R, Li XR, Hooymans JM, Los LI. Idiopathic epiretinal membrane. Retina. 2014 Dec;34(12):2317-35. doi: 10.1097/IAE.0000000000000349.

  PMID: 25360790 BACKGROUND

• Frisina R, Pinackatt SJ, Sartore M, Monfardini A, Baldi A, Cesana BM, Semeraro F, Bratu A, Parolini B. Cystoid macular edema after pars plana vitrectomy for idiopathic epiretinal membrane. Graefes Arch Clin Exp Ophthalmol. 2015 Jan;253(1):47-56. doi: 10.1007/s00417-014-2655-x. Epub 2014 May 25.

  PMID: 24859385 BACKGROUND

• Leisser C, Hirnschall N, Hackl C, Doller B, Varsits R, Ullrich M, Kefer K, Karl R, Findl O. Risk factors for postoperative intraretinal cystoid changes after peeling of idiopathic epiretinal membranes among patients randomized for balanced salt solution and air-tamponade. Acta Ophthalmol. 2018 Jun;96(4):e439-e444. doi: 10.1111/aos.13635. Epub 2018 Feb 20.

  PMID: 29461674 BACKGROUND

• Leisser C, Amon DL, Huemer JC, Findl O. Diagnostic Reliability of Optical Coherence Tomography Biomarkers for Postsurgical Success in Visual Acuity in Patients with Idiopathic Epiretinal Membranes. Klin Monbl Augenheilkd. 2023 Oct;240(10):1207-1213. doi: 10.1055/a-1756-5243. Epub 2022 Apr 14. English, German.

  PMID: 35426108 BACKGROUND

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Christoph Leisser, MD

  Vienna Institute for Research in Ocular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department, Professor, Sponsor-Investigator

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 29, 2025
• Study Start: May 16, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)