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

NCT06198738 | Unknown

• 1 other identifier: 344/23
• Study Type: observational
• Target: 323
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Emulsification of Silicone Oil in Eye Following Surgical Procedure

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  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

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

• Correlation between the value of the ITMES score and postoperative retinal attachment

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

• Correlation between the value of the ITMES score and postoperative best-corrected visual acuity

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients meeting the inclusion criteria

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cliniche Humanitas Gavazzeni: lead

Central Study Contacts

Mario R Romano, MD PhD

CONTACT

+39 035 283511; mario.romano.md@gmail.com

Mariantonia Ferrara, MD

CONTACT

+39 035 283511; mariantonia.ferrara@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 10, 2024
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01