Vitreous DisorderNCT04570007
Vitreous Fragments Length After Pars Plana Vitrectomy
An observational study of Vitreous Disorder and Vitreous Anomalies, run by Ospedale Policlinico San Martino at 1 site in Italy.
Trial summary
To measure vitreous collagen fragments length after pars plana vitrectomy performed at different cut rates Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Vitreous Disorder, Vitreous Anomalies
- What is being tested?
- Pars Plana Vitrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 20 Sep 2020to 10 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: patients over 18 undergoing pars plana vitrectomy for macular surgery or retinal detachment
Who may be able to join
- patient undergoing pars plana vitrectomy for:
- macular pucker
- macular hole-
- retinal detachment
- age >18
Who cannot join
- unwilling to participate
- previous trauma
- vitreous haemorrhage
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Martino
Genova, RM, 16100
Tommaso Rossi, 3482645034, tommaso.rossi024@gmail.com
About this study
To measure vitreous collagen fragments length after pars plana vitrectomy performed at different cut rates
Read the 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
- Conditions
- Vitreous Disorder, Vitreous Anomalies
- Being tested
- Pars Plana Vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars Plana VitrectomyProcedure or surgery
removal of vitreous with vitreous cutter
What is being measured
The primary outcome is the main question the study is designed to answer.
collagen fragment molecular weigth
collagen passed through the vitreous cutter is examined with regard to collagen moecular weigth
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start20 Sep 2020
- Primary completion30 Oct 2021 (estimated)
- Study completion10 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreous DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Policlinico San Martino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tommaso Rossi, Principal investigator, IRCCS Policlinico San MArtino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570007
- Sponsor's protocol ID
- 2/2020
- Status last verified
- Sep 2021
- First submitted
- 24 Sep 2020
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitreous Fragments Length After Pars Plana Vitrectomy
- ClinicalTrials.gov ID
- NCT04570007
- Acronym / sponsor ID
- 2/2020
- Conditions
- Vitreous Disorder, Vitreous Anomalies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Ospedale Policlinico San MartinoUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 10 Dec 2021 (estimated)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To measure vitreous collagen fragments length after pars plana vitrectomy performed at different cut rates
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients over 18 undergoing pars plana vitrectomy for macular surgery or retinal detachment
Key inclusion criteria (5 listed)
- patient undergoing pars plana vitrectomy for:
- macular pucker
- macular hole-
- retinal detachment
- age >18
Key exclusion criteria (3 listed)
- unwilling to participate
- previous trauma
- vitreous haemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pars Plana Vitrectomyremoval of vitreous with vitreous cutter | Procedure or surgery | – |
Primary outcome
collagen fragment molecular weigth
Time frame: at time of surgery
collagen passed through the vitreous cutter is examined with regard to collagen moecular weigth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tommaso Rossi principal investigator
IRCCS Policlinico San MArtino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitreous Disorder and Vitreous Anomalies, run by Ospedale Policlinico San Martino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tommaso Rossi (+393482645034, tommaso.rossi024@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
collagen fragment molecular weigth (time frame: at time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.