Correlation Between Silicone-oil Related Ocular Complications and ITMES Score (CLIN-ITEMS) (CLIN-ITEMS)

January 17, 2024 updated by: Mario R Romano, Cliniche Humanitas Gavazzeni

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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

323

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 Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All adult patients meeting the inclusion criteria

Description

Inclusion Criteria: One eye requiring pars plana vitrectomy and silicone oil/heavy silicone oil tamponade, OR pars plana vitrectomy and removal of silicone oil/heavy silicone oil OR one silicone-oil filled eye.

Exclusion Criteria:

  • 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.

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
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)
Baseline, 1 day, 1 month, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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
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)
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
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)
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
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)
Baseline, 1 day, 1 month, 3 months and 6 months

Collaborators and Investigators

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

Sponsor

Cliniche Humanitas Gavazzeni

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 (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 27, 2023

First Submitted That Met QC Criteria

December 27, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 344/23

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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