Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06948851

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vienna Institute for Research in Ocular Surgery

Vienna, 1040, Austria

About this study

Epiretinal membranes (ERM) are a macular disorder leading to metamorphopsia and a decrease in visual acuity. While ERM are rare among young people, they have prevalence rates of up to 30% in the age groups of 70 years or older. Peeling of ERM during vitrectomy is, up to date, the only possible treatment option, opening chances for improvements of visual acuity and metamorphopsia. Nevertheless, there is a risk for development of new intraretinal cystoid changes after peeling of ERM in about 10% of patients. Preoperative presence of intraretinal cystoid changes was already described as a risk factor for postsurgical presence of intraretinal cystoid changes and and 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. Biomarker in presurgical optical coherence tomography (OCT) have been described to be associated with postsurgical results. Using a multivariable approach of analysis, presurgical DRIL and higher central macular thickness (CMT) were significant negative predictors on postsurgical visual acuity three months after surgery. However, influence of preoperative OCT biomarkers on development of new postsurgical intraretinal cystoid changes was not examined in theses studies. Aim of our study was to analyze development of new intraretinal cystoid changes after vitrectomy with membrane peeling with respect to postsurgical treatment strategies.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • age below 18 years

Treatment and study plan

Primary outcomes

  1. new postoperative intraretinal cystoid changes

    Time frame: 3 months after surgery

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

Secondary outcomes

  1. Maximum diameter of postoperative intraretinal cystoid changes

    Time frame: 3 months after surgery

    Maximum diameter is measured in µm from OCT images 3 months after surgery

Sponsors and collaborators

Lead sponsor

Prim. Prof. Dr. Oliver Findl, MBA

Other

Registry information

Official study title

Development of New Postoperative Intraretinal Cystoid Changes With Respect to Postsurgical Treatment Strategies After Vitrectomy With Membrane Peeling Due to Epiretinal Membranes

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.