Quantification of Factors Influencing Endothelial Damage During Phacoemulsification (PREDICSPILOT)

Centre Hospitalier Régional Metz-Thionville

Status: Completed

Conditions: Cataract; Phacoemulsification; Endothelial Cell Loss, Corneal

Treatments: Procedure: Cataract surgery by phacoemulsification

Study type: Observational

Funder types: Other

Identifiers

NCT05529485

2022-11Obs-CHRMT

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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