Emulsification of Silicone Oil in Eye Following Surgical ProcedureCLIN-ITEMSNCT06198738
Correlation Between Silicone-oil Related Ocular Complications and ITMES Score (CLIN-ITEMS)
An observational study of Emulsification of Silicone Oil in Eye Following Surgical Procedure, run by Cliniche Humanitas Gavazzeni.
Trial summary
Prospective, multicentric, observational study aimed to evaluate the correlation between the value of the InTraocular EMulsion of Silicone oil (ITMES) score assessed at clinical examination and silicone oil-related ocular complications. This will allow to clinically validate the ITEMS score, as clinical tool. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emulsification of Silicone Oil in Eye Following Surgical Procedure
- How many people
- 323 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients meeting the inclusion criteria
Who may be able to join
None listed.
Who cannot join
- untreated or uncontrolled ocular disease leading to unacceptable higher risk of intra- and post-operative complications, such as uncontrolled ocular inflammation or infection, untreated ocular malignancy and uncontrolled glaucoma;
- uncontrolled severe systemic disease related to significantly higher operative risk;
- pregnant women due to the specific risks related to supine position during surgery, operative time, risks of retrobulbar anesthesia, and intraoperative and postoperative drugs;
- inability to give written consent.
Trial locations and contacts
No sites are listed yet.
About this study
Prospective, multicentric, observational study aimed to evaluate the correlation between the value of the InTraocular EMulsion of Silicone oil (ITMES) score assessed at clinical examination and silicone oil-related ocular complications. This will allow to clinically validate the ITEMS score, as clinical tool.
Demographic data and clinical findings, including the ITEMS score, of patients undergoing to vitrectomy and silicone oil tamponade or removal of silicone oil or having one silicone oil-filled eye, will be collected at the baseline and at each follow-up visit (at 1-day, 1-, 3- and 6-month after surgery).
The prognostic performance of the ITEMS score will be evaluated in agreement with the TRIPOD statement.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the value of the ITMES score and any silicone oil-related ocular complication
The InTraocular EMulsion of Silicone oil (ITEMS) grading system has been proposed for the assessment of silicone oil emulsion to more reliably quantify the presence and extent of any SO emulsion, applicable in a daily clinical setting and validated through an expert panel consensus procedure (Romano MR, et al, INTRAOCULAR EMULSION OF SILICONE OIL (ITEMS) GRADING SYSTEM: An Evidence-Based Expert-Led Consensus. Retina 2023 Aug 1;43(8):1370-1376)
Measured: Baseline, 1 day, 1 month, 3 months and 6 months
Secondary outcomes (4)
Correlation between the value of the ITMES score and any single types of intraoperative silicone oil-related ocular complication
The InTraocular EMulsion of Silicone oil (ITEMS) grading system has been proposed for the assessment of silicone oil emulsion to more reliably quantify the presence and extent of any SO emulsion, applicable in a daily clinical setting and validated through an expert panel consensus procedure (Romano MR, et al, INTRAOCULAR EMULSION OF SILICONE OIL (ITEMS) GRADING SYSTEM: An Evidence-Based Expert-Led Consensus. Retina 2023 Aug 1;43(8):1370-1376)
Measured: Baseline, 1 day, 1 month, 3 months and 6 months
Correlation between the value of the ITMES score and any single types of postoperative silicone oil-related ocular complication
The InTraocular EMulsion of Silicone oil (ITEMS) grading system has been proposed for the assessment of silicone oil emulsion to more reliably quantify the presence and extent of any SO emulsion, applicable in a daily clinical setting and validated through an expert panel consensus procedure (Romano MR, et al, INTRAOCULAR EMULSION OF SILICONE OIL (ITEMS) GRADING SYSTEM: An Evidence-Based Expert-Led Consensus. Retina 2023 Aug 1;43(8):1370-1376)
Measured: Baseline, 1 day, 1 month, 3 months and 6 months
Correlation between the value of the ITMES score and postoperative retinal attachment
The InTraocular EMulsion of Silicone oil (ITEMS) grading system has been proposed for the assessment of silicone oil emulsion to more reliably quantify the presence and extent of any SO emulsion, applicable in a daily clinical setting and validated through an expert panel consensus procedure (Romano MR, et al, INTRAOCULAR EMULSION OF SILICONE OIL (ITEMS) GRADING SYSTEM: An Evidence-Based Expert-Led Consensus. Retina 2023 Aug 1;43(8):1370-1376)
Measured: Baseline, 1 day, 1 month, 3 months and 6 months
Correlation between the value of the ITMES score and postoperative best-corrected visual acuity
The InTraocular EMulsion of Silicone oil (ITEMS) grading system has been proposed for the assessment of silicone oil emulsion to more reliably quantify the presence and extent of any SO emulsion, applicable in a daily clinical setting and validated through an expert panel consensus procedure (Romano MR, et al, INTRAOCULAR EMULSION OF SILICONE OIL (ITEMS) GRADING SYSTEM: An Evidence-Based Expert-Led Consensus. Retina 2023 Aug 1;43(8):1370-1376)
Measured: Baseline, 1 day, 1 month, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emulsification of Silicone Oil in Eye Following Surgical ProcedureStudies 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
- 323 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniche Humanitas Gavazzeni
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario R Romano, Cliniche Humanitas Gavazzeni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198738
- Sponsor's protocol ID
- 344/23
- Acronym
- CLIN-ITEMS
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Silicone-oil Related Ocular Complications and ITMES Score (CLIN-ITEMS)
- ClinicalTrials.gov ID
- NCT06198738
- Acronym / sponsor ID
- CLIN-ITEMS / 344/23
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- Cliniche Humanitas GavazzeniUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Jan 2024 (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.
Prospective, multicentric, observational study aimed to evaluate the correlation between the value of the InTraocular EMulsion of Silicone oil (ITMES) score assessed at clinical examination and silicone oil-related ocular complications. This will allow to clinically validate the ITEMS score, as clinical tool.
Demographic data and clinical findings, including the ITEMS score, of patients undergoing to vitrectomy and silicone oil tamponade or removal of silicone oil or having one silicone oil-filled eye, will be collected at the baseline and at each follow-up visit (at 1-day, 1-, 3- and 6-month after surgery).
The prognostic performance of the ITEMS score will be evaluated in agreement with the TRIPOD statement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients meeting the inclusion criteria
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- untreated or uncontrolled ocular disease leading to unacceptable higher risk of intra- and post-operative complications, such as uncontrolled ocular inflammation or infection, untreated ocular malignancy and uncontrolled glaucoma;
- uncontrolled severe systemic disease related to significantly higher operative risk;
- pregnant women due to the specific risks related to supine position during surgery, operative time, risks of retrobulbar anesthesia, and intraoperative and postoperative drugs;
- inability to give written consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between the value of the ITMES score and any silicone oil-related ocular complication
Time frame: Baseline, 1 day, 1 month, 3 months and 6 months
The InTraocular EMulsion of Silicone oil (ITEMS) grading system has been proposed for the assessment of silicone oil emulsion to more reliably quantify the presence and extent of any SO emulsion, applicable in a daily clinical setting and validated through an expert panel consensus procedure (Romano MR, et al, INTRAOCULAR EMULSION OF SILICONE OIL (ITEMS) GRADING SYSTEM: An Evidence-Based Expert-Led Consensus. Retina 2023 Aug 1;43(8):1370-1376)
4 secondary outcomes
Correlation between the value of the ITMES score and any single types of intraoperative silicone oil-related ocular complication
Time frame: Baseline, 1 day, 1 month, 3 months and 6 months
Correlation between the value of the ITMES score and any single types of postoperative silicone oil-related ocular complication
Time frame: Baseline, 1 day, 1 month, 3 months and 6 months
Correlation between the value of the ITMES score and postoperative retinal attachment
Time frame: Baseline, 1 day, 1 month, 3 months and 6 months
Correlation between the value of the ITMES score and postoperative best-corrected visual acuity
Time frame: Baseline, 1 day, 1 month, 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Emulsification of Silicone Oil in Eye Following Surgical Procedure, run by Cliniche Humanitas Gavazzeni.
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 0 inclusion and 4 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 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Mario R Romano, MD PhD (+39 035 283511, mario.romano.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the value of the ITMES score and any silicone oil-related ocular complication (time frame: Baseline, 1 day, 1 month, 3 months and 6 months). 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 18 Jan 2024.