CompletedNot Applicable

Silicone Effect on Corneal Endothelium and Corneal Biomechanics Using Corvis ST

Egypt80 participantsStarted 2022-05-01

Plain-language 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.

Who can participate

Age range

20 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients undergoing vitrectomy. * Clear cornea. * Central corneal thickness (CCT) ≥ 500 µm. * Age between 20 and 50 years. Exclusion Criteria: * History of intraocular surgery. * Ocular pathologies, such as corneal scarring or dystrophy. * Advanced keratoconus.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Corneal Endothelial Cell Density (ECD)

Timeframe: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively.

Morphological Changes in Corneal Endothelium

Timeframe: Baseline, 1, 3, and 6 months.

Corneal Biomechanical Properties

Timeframe: Baseline, 1, 3, and 6 months.

Trial details

NCT IDNCT06861946

SponsorBeni-Suef University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-10-01

View on ClinicalTrials.gov More Silicon Oil Effect on Cornea trials