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Silicone Effect on Corneal Endothelium and Corneal Biomechanics Using Corvis ST

NCT06861946 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-03-06

No results posted yet for this study

Summary

Brief Summary

The goal of this observational study is to investigate the effects of silicone oil tamponade on corneal endothelial cell density (ECD), morphology, and biomechanics in patients undergoing vitrectomy for retinal detachment (20 patients, 20 eyes). The main questions it aims to answer are:

How does silicone oil tamponade affect corneal ECD, morphology, and biomechanics over 6 months postoperatively?

Are these changes associated with variations in best-corrected visual acuity (BCVA) or intraocular pressure (IOP)?

Comparison group: Researchers will compare preoperative measurements to 1-, 3-, and 6-month postoperative assessments to evaluate changes in endothelial parameters and corneal biomechanics.

Participants will:

Undergo preoperative and postoperative assessments (at 1, 3, and 6 months) using specular microscopy (to measure ECD, coefficient of variation, hexagonality) and Corvis ST (to evaluate biomechanical properties: Stress-Strain Index and deformation amplitude).

Have BCVA and IOP measured at each follow-up visit to track clinical outcomes.

Conditions

  • Silicon Oil Effect on Cornea
  • Corneal Biomechanics

Interventions

DIAGNOSTIC_TEST

Corvis ST

Corvis ST is used to assess corneal biomechanical changes following vitrectomy with silicone oil tamponade, specifically: Corneal stiffness and elasticity using the Stress-Strain Index (SSI) Corneal deformation response via Deformation Amplitude (DA)

DIAGNOSTIC_TEST

Conrneal endothelial cell density

The study evaluates the impact of silicone oil tamponade on corneal endothelial cell density (ECD) in patients undergoing vitrectomy for retinal detachment. The intervention involves: Preoperative and Postoperative Assessments at 1, 3, and 6 months to monitor changes in ECD. Specular Microscopy to measure ECD (cells/mm²), coefficient of variation (CV) in cell size, and hexagonality (% of hexagonal cells).

Sponsors & Collaborators

  • Beni-Suef University

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2024-10-01
Completion
2024-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06861946 on ClinicalTrials.gov