Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started May 2022

Typical duration for all trials

Geographic Reach

1 country

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

Study Start

First participant enrolled

May 1, 2022

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2025

Completed

13 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed

Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2.4 years

First QC Date

February 21, 2025

Last Update Submit

March 2, 2025

Conditions

Silicon Oil Effect on Cornea Corneal Biomechanics

Keywords

Corneal biomechanicsSpecular microscopysilicon oilendothelial cell density

Outcome Measures

Primary Outcomes (3)

Change in Corneal Endothelial Cell Density (ECD)
Measurement: Cells/mm², assessed via specular microscopy (Konan Noncon Robo NSP-9900).
Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively.
Morphological Changes in Corneal Endothelium
Parameters: Coefficient of Variation (CV): Reflects cell size variability (polymegathism). Hexagonality: Percentage of hexagonal cells (pleomorphism). Measurement: Specular microscopy. CV and hexagonality are vital for evaluating corneal endothelial health. Optimal outcomes are associated with low CV (\<30%) and high hexagonality (\>60%), while deviations signal pathology or risk. Specular microscopy remains the gold standard for non-invasive assessment.
Baseline, 1, 3, and 6 months.
Corneal Biomechanical Properties
Parameters: Stress-Strain Index (SSI): Quantifies corneal stiffness. Deformation Amplitude (DA): Maximum corneal displacement during air-puff applanation. Measurement: Corvis ST (Oculus Optikgeräte GmbH). Normal Ranges: SSI: Typically ranges between \~50-100 (unitless), though values vary by population and device software. DA: Normal corneas average \~1.0-1.2 mm, while keratoconic corneas often exceed 1.3 mm.
Baseline, 1, 3, and 6 months.

Secondary Outcomes (3)

Best-Corrected Visual Acuity (BCVA)
Baseline, 1, 3, and 6 months.
Intraocular Pressure (IOP)
Baseline, 1, 3, and 6 months.
Correlation Between Corneal Changes and Clinical Outcomes
Baseline, 1, 3, and 6 months.