NCT04570007

Brief Summary

To measure vitreous collagen fragments length after pars plana vitrectomy performed at different cut rates

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

September 20, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
Last Updated

October 27, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

September 24, 2020

Last Update Submit

October 26, 2021

Conditions

Vitreous DisorderVitreous Anomalies

Outcome Measures

Primary Outcomes (1)

  • collagen fragment molecular weigth

    collagen passed through the vitreous cutter is examined with regard to collagen moecular weigth

    at time of surgery

Interventions

Pars Plana VitrectomyPROCEDURE

removal of vitreous with vitreous cutter

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients over 18 undergoing pars plana vitrectomy for macular surgery or retinal detachment

You may qualify if:

  • patient undergoing pars plana vitrectomy for:
  • macular pucker
  • macular hole-
  • retinal detachment
  • age \>18

You may not qualify if:

  • unwilling to participate
  • previous trauma
  • vitreous haemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Martino

Genova, RM, 16100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

vitreous collagen

Study Officials

  • Tommaso Rossi

    IRCCS Policlinico San MArtino

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tommaso Rossi

CONTACT

+393482645034tommaso.rossi024@gmail.com

Study Design

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

Study Record Dates

First Submitted

September 24, 2020

First Posted

September 30, 2020

Study Start

September 20, 2020

Primary Completion

October 30, 2021

Study Completion

December 10, 2021

Last Updated

October 27, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)