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Active, not recruitingNCT06948851Updated Apr 29, 2025

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

An observational study in Epiretinal Membrane, sponsored by Prim. Prof. Dr. Oliver Findl, MBA. Active, not recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-29.

Sponsored by Prim. Prof. Dr. Oliver Findl, MBA · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
114
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

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.

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Conditions studied

  • Epiretinal Membrane

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03

In context

Epiretinal Membrane

130 studies on the registry are indexed under Epiretinal Membrane; 18 are open to participants now.

This study's enrollment of 114 is above the median of 60 across 48 observational studies indexed under Epiretinal Membrane.

Browse Epiretinal Membrane studies →

Lead sponsor

Prim. Prof. Dr. Oliver Findl, MBA is the lead sponsor of 39 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • age below 18 years
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
114 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. new postoperative intraretinal cystoid changes

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

    Time frame: 3 months after surgery

Secondary outcomes

  1. Maximum diameter of postoperative intraretinal cystoid changes

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

    Time frame: 3 months after surgery

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Study locations

1 site
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References and documents

Publications

  • 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. PubMed 9186446 ↗
  • 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. PubMed 25360790 ↗
  • 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. PubMed 24859385 ↗
  • 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. PubMed 29461674 ↗
  • 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. PubMed 35426108 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06948851
Lead sponsor
Prim. Prof. Dr. Oliver Findl, MBA
Responsible party
Prim. Prof. Dr. Oliver Findl, MBA (Head of Department, Professor, Sponsor-Investigator, Vienna Institute for Research in Ocular Surgery) — Sponsor-investigator
First posted
Apr 29, 2025
Start date
May 16, 2024
Primary completion
Apr 30, 2025 (estimated)
Completion
Apr 30, 2025 (estimated)
Last update
Apr 29, 2025

Study contacts

Christoph Leisser, MD
principal investigator · Vienna Institute for Research in Ocular Surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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