Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2020
CompletedFirst Submitted
Initial submission to the registry
July 11, 2020
CompletedFirst Posted
Study publicly available on registry
July 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2020
CompletedSeptember 29, 2020
September 1, 2020
3 months
July 11, 2020
September 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Intraretinal cystoid changes
presence of intraretinal cystoid changes in OCT is assessed during the time period of 3 months after surgery
3 months
Secondary Outcomes (2)
intraocular pressure (IOP)
3 months
distance corrected visual acuity
3 months
Study Arms (1)
Studygroup
Retrospective analysis of OCT, IOP and distance corrected visual acuity from the patients history.
Interventions
OCT visualizes the retinal layers by backreflection of light
Eligibility Criteria
Patients having undergone pars plana vitrectomy with membrane peeling and periocular application of triamcinolone acetonide at the end of surgery between June 2019 and January 2020 at the department of Ophthalmology of the Hanusch Hospital in Vienna, Austria, were selected for the study
You may qualify if:
- 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
You may not qualify if:
- macular edema caused by conditions other than ERM (such as choroidal neovascularization, diabetic macular edema, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Vienna, 1140, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Findl, Prof.
Vienna Institute for Research in Ocular Surgery
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Oliver Findl, MBA
Study Record Dates
First Submitted
July 11, 2020
First Posted
July 15, 2020
Study Start
June 30, 2020
Primary Completion
September 28, 2020
Study Completion
September 28, 2020
Last Updated
September 29, 2020
Record last verified: 2020-09