Influencing Factors of the Corneal Endothelial Cell Loss

Study Overview
=================
Brief Summary
-----------------
This is a multi-center cohort study with prognostic aims to identify factors associated with endothelial cell loss during cataract surgery. Patients will have their endothelial density measured by specular microscopy preoperatively, at 1 month and at 3 months after surgery. The rest of their management will be in line with standard practice.

Detailed Description
-----------------
Cataract surgery is the most commonly performed surgical procedure worldwide. Postoperative visual function depends on implant into the crystalline lens, retinal lesion, corneal damage or glaucomatous damage. Moreover, preoperative corneal endothelial damage should be as low as possible to provide corneal transparency. Indeed, the endothelium plays important role in maintaining corneal transparency. The loss rate of endothelial cell after cataract surgery ranges in the scientific literature from 8 to 15 %. Severe endothelial cell loss contributes to corneal edema. This edema resulting in a loss of visual acuity and may require corneal transplantation as a last resort. Various studies describe some factors that affecting endothelial cell loss such as the cataract density, pupil abnormalities (small diameter), Advanced age or short axial length. However, few studies have been demonstrated the link between endothelial cell loss and the volume of fluid used during the intervention or the use of intracamerular substances. This study wants to establish a correlation between endothelial cell loss and predictive factors. Thus, knowledge of these factors would have ensured a better control of endothelial dysfunction.

Official Title
-----------------
Identification of Factors That Influence the Corneal Endothelial Cell Loss During Phacoemulsification

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Procedure: Phacoemulsification


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cataract surgery<br>Phacoemulsification cataract surgery | Procedure: Phacoemulsification<br>* Endocapsular technique (Divide-and-conquer) and supracapsular technique (Subluxation) will be used equally.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative endothelial cell loss | Difference in endothelial cell density between preoperative measurements and 3 months after surgery | Month 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endothelial cell loss