Quantification of Factors Influencing Endothelial Damage During Phacoemulsification

Cataract Clinical Trial

— PREDICSPILOT  

Official title:

Research and Quantification of Factors Influencing Endothelial Damage During Phacoemulsification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05529485
• Other study ID #: 2022-11Obs-CHRMT
• Status: Completed
• Start date: January 12, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Corneal Endothelial Cell Loss
• Endothelial Cell Loss, Corneal
• Phacoemulsification

Intervention

Procedure:
• Cataract surgery by phacoemulsification
Cataract surgery by phacoemulsification

Locations

Country	Name	City	State
France	CHR Metz-Thionville/Hopital de Mercy	Metz

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Postoperative corneal edema	Corneal edema is measured using specular microscope with pachymeter	3 months after cataract surgery