Quantification of Factors Influencing Endothelial Damage During Phacoemulsification

Completed

• Conditions: Endothelial Cell Loss, Corneal; Phacoemulsification; Cataract

• Registration Number: NCT05529485
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

Brief Summary

The aim of this study is to determine the principal factors that influence endothelial cell loss three month post cataract surgery.

Methods: Multi center observational Cohort study, inclusion period from 12/01/2022 to 10/06/2022. One hundred and seventy-five eyes of hundred and four patients who have appointment for cataract surgical indication were included. The percentage of corneal endothelial cell loss was quantified using specular microscopy before and 3 months after the surgery.

14 variables (pre-operative and intra-operative) that could be associated to endothelial cell injury were selected.

A bivariate analysis of relationship between these factors and endothelial cell loss at 3 months was performed by simple linear regression (Wilcoxon and Fischer tests). Multivariate analysis was performed by multiple linear regression in order to identify the factors independently related to endothelial cell loss.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-12
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Last Update Submitted: 2022-09-07
• Last Update Posted: 2022-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• Patients undergoing cataract surgery
• Visual acuity monoyer scale <8/10e (> +0.2 logMar)
• Nuclear, cortical and posterior subcapsular cataract with normal density to severe in the LOCSIII classification
• Covered by the social security scheme
• Have given their oral agreement

Exclusion Criteria

• Corneal disease: keratitis, dystrophy or corneal degeneration
• Any disease of the anterior segment
• Low preoperative endothelial cell density <1000 c/mm²
• Pregnancy, lactation
• Risk factors for surgical per-operative complication
• Uncontrolled ocular pressure
• Combined surgery (cataract with corneal graft, cataract with glaucoma surgery, cataract with vitrectomy, ....)
• Under legal protection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in central corneal endothelial cell density (cells/mm²) between the 1st preoperative measurement and the postoperative measurement at 3 months.	3 months after cataract surgery	Specular counts were performed by the orthoptists, residents or physicians of the department using a Nidek CEM-530 specular microscope with automated central cell counting without corneal contact. Three measurements were performed at each consultation and the average of these three measurements was reported.

Secondary Outcome Measures

Name	Time	Method
Postoperative corneal edema	3 months after cataract surgery	Corneal edema is measured using specular microscope with pachymeter
Postoperative visual acuity	3 months after cataract surgery	best spectacle corrected visual acuity is evaluated using Monoyer scale, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best.

Trial Locations

Locations (1)

CHR Metz-Thionville/Hopital de Mercy; 🇫🇷 Metz, France