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.

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Key information

Conditions

Endothelial Cell Loss, Corneal Cataract Corneal Diseases Corneal Endothelial Cell Loss Eye Diseases Eye Manifestations Lens Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phacoemulsification Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cataract surgery by phacoemulsification

Procedure

Cataract surgery by phacoemulsification

Primary outcomes

The difference in central corneal endothelial cell density (cells/mm²) between the 1st preoperative measurement and the postoperative measurement at 3 months.

Time frame: 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 outcomes

Postoperative visual acuity

Time frame: 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.
Postoperative corneal edema

Time frame: 3 months after cataract surgery

Corneal edema is measured using specular microscope with pachymeter

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

Research and Quantification of Factors Influencing Endothelial Damage During Phacoemulsification

Acronym: PREDICSPILOT

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Sep 7, 2022
Registry last updated: Sep 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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