NCT06861946|Completed
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Sponsor study identifier
observational
80
1 country
2
Study Start
May 1, 2022
Actual (reported)Primary Completion
October 1, 2024
Actual (reported)Study Completion
December 31, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2022
Actual (reported)October 1, 2024
Actual (reported)December 31, 2024
Actual (reported)February 21, 2025
Actual (reported)March 6, 2025
Actual (reported)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.
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.
Vitrectomy with 1000 cSt silicone oil.
Phaco vitrectomy with 1000 cSt silicone oil.
Vitrectomy with 5000 cSt silicone oil.
Phaco vitrectomy with 5000 cSt silicone oil.
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)
Patients undergoing vitrectomy with silicone oil tamponade for the treatment of rhegmatogenous retinal detachment (RRD).
Fayoum University Hospital
Al Fayyum, Faiyum Governorate, Egypt
Misr University For Science and Technology
Giza, Egypt
Goezinne F, Nuijts RM, Liem AT, Lundqvist IJ, Berendschot TJ, Cals DW, Hendrikse F, La Heij EC. Corneal endothelial cell density after vitrectomy with silicone oil for complex retinal detachments. Retina. 2014 Feb;34(2):228-36. doi: 10.1097/IAE.0b013e3182979b88.
Latkowska M, Gajdzis M, Kaczmarek R. Emulsification of Silicone Oils: Altering Factors and Possible Complications-A Narrative Review. J Clin Med. 2024 Apr 20;13(8):2407. doi: 10.3390/jcm13082407.
80 participants (actual enrollment reported by the registry).
First Submitted
February 21, 2025
First Posted
March 6, 2025
Study Start
May 1, 2022
Actual (reported)Control group (other eyes).
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).
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Primary Completion
October 1, 2024
Actual (reported)Study Completion
December 31, 2024
Actual (reported)Last Updated
March 6, 2025
Record last verified: 2025-03
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Source: ClinicalTrials.gov.
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