Quantification of Factors Influencing Endothelial Damage During Phacoemulsification (PREDICSPILOT)

Research and Quantification of Factors Influencing Endothelial Damage During Phacoemulsification

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Endothelial Cell Loss, Corneal; Phacoemulsification
• Intervention / Treatment: Procedure: Cataract surgery by phacoemulsification

• Study Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

• France
  • Metz, France, 57085
    • CHR Metz-Thionville/Hopital de Mercy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cataract surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference in central corneal endothelial cell density (cells/mm²) between the 1st preoperative measurement and the postoperative measurement at 3 months.	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.	3 months after cataract surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative visual acuity	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.	3 months after cataract surgery
Postoperative corneal edema	Corneal edema is measured using specular microscope with pachymeter	3 months after cataract surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Jean Marc Perone, CHR Metz Thionville Hopital de Mercy

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Postoperative Complications; Lens Diseases; Corneal Diseases; Eye Manifestations; Cataract; Corneal Endothelial Cell Loss
• Other Study ID Numbers: 2022-11Obs-CHRMT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No