Vitreous Fragments Length After Pars Plana Vitrectomy

October 26, 2021 updated by: Ospedale Policlinico San Martino
To measure vitreous collagen fragments length after pars plana vitrectomy performed at different cut rates

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Pars plana vitrectomy consists in the removal of vitreous obtained with a vitreous cutter. The instruments attracts vitreous in its port through active suction and cuts with a blade at different cut rates. There is no consensus as to which cut rate would be ideal in order to minimize traction, neither there is agreement on whether increasing cut rates generate shorter collagen fragments or the fluid turbulence creates unpredictable flows at the port generating fragments of different length.

The investigators plan to gather vitreous cut at 1,000, 2,000, 4,000, 8,000 and 16,000 cuts per minute and measure vitreous collagen average length

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • RM
      • Genova, RM, Italy, 16100
        • Recruiting
        • IRCCS Policlinico San Martino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • unwilling to participate
  • previous trauma
  • vitreous haemorrhage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
collagen fragment molecular weigth
Time Frame: at time of surgery
collagen passed through the vitreous cutter is examined with regard to collagen moecular weigth
at time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Policlinico San Martino

Investigators

  • Principal Investigator: Tommaso Rossi, IRCCS Policlinico San Martino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2020

Primary Completion (Anticipated)

October 30, 2021

Study Completion (Anticipated)

December 10, 2021

Study Registration Dates

First Submitted

September 24, 2020

First Submitted That Met QC Criteria

September 24, 2020

First Posted (Actual)

September 30, 2020

Study Record Updates

Last Update Posted (Actual)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 26, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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