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Completed

NCT Number: NCT04472039

Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling

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.

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Key information

Conditions

Macular Edema, Cystoid Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Vienna, 1140, Austria

About this study

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.

Who can participate

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

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.)

Treatment and study plan

Optical coherence tomography (OCT)

Device

OCT visualizes the retinal layers by backreflection of light

Primary outcomes

  1. Intraretinal cystoid changes

    Time frame: 3 months

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

Secondary outcomes

  1. intraocular pressure (IOP)

    Time frame: 3 months

    intraocular pressure is examined during the time period of 3 months after surgery

  2. distance corrected visual acuity

    Time frame: 3 months

    distance corrected visual acuity is measured at baseline and 3 months after surgery

Sponsors and collaborators

Lead sponsor

Vienna Institute for Research in Ocular Surgery

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 15, 2020
Registry last updated
Sep 29, 2020

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.

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