NCT05517473

Brief Summary

In this study, the investigators aim to collect data regarding the efficiency and safety of two dyes used intraoperatively in vitrectomy to stain intraocular tissues. These products have the necessary approvals to use during such operation,These are NOT experimental products.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

1 month

First QC Date

August 18, 2022

Last Update Submit

August 23, 2022

Conditions

Macular HolesMacular PuckerVitreomacular Traction

Outcome Measures

Primary Outcomes (1)

  • visualization of membranes

    visualization of membranes stained based on binary subjective evaluation.

    intraoperative (surgery day)

Secondary Outcomes (3)

  • surgical help

    intraoperative (surgery day)

  • adverse events

    1 day after surgery

  • visual acuity

    6 weeks after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients who underwent for vitrectomy surgery where ILM and/or ERM removal is required: * Macular holes (ILM staining) * Macular pucker (ILM and ERM staining) * Vitreomacular traction (ILM staining)

You may qualify if:

  • Adult patients who underwent for vitrectomy surgery where ILM and/or ERM removal is required:
  • Macular holes (ILM staining)
  • Macular pucker (ILM and ERM staining)
  • Vitreomacular traction (ILM staining)

You may not qualify if:

  • Children aged \<18 years
  • Vitrectomy for other indication than mentioned in 3.1
  • Patients that have concomitant eye disease that may influence the outcome of the surgery, e.g. terminal glaucoma
  • Patients that did to comply to the postoperative examination visit 6-10 weeks after the surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Retinal PerforationsEpiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Peter Stalmans, Phd

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 26, 2022

Study Start

July 5, 2022

Primary Completion

August 16, 2022

Study Completion

August 16, 2022

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)