Quantification of Factors Influencing Endothelial Damage During Phacoemulsification

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-12

Study Completion Date

2022-08-01

Brief Summary

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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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Detailed Description

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Conditions

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Endothelial Cell Loss, Corneal Cataract Phacoemulsification

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Cataract surgery by phacoemulsification

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No