NCT04472039

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

July 11, 2020

Last Update Submit

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.

Device: optical coherence tomography (OCT)

Interventions

OCT visualizes the retinal layers by backreflection of light

Studygroup

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Oliver Findl, Prof.

    Vienna Institute for Research in Ocular Surgery

    PRINCIPAL INVESTIGATOR

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

Locations