Influencing Factors of the Corneal Endothelial Cell Loss

NCT ID: NCT05265832

Last Updated: 2023-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-04
• Study Completion Date: 2023-09-04

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.

Conditions

Cataract

Keywords

Endothelial cell loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cataract surgery

Phacoemulsification cataract surgery

Group Type: EXPERIMENTAL

Phacoemulsification

Intervention Type: PROCEDURE

Endocapsular technique (Divide-and-conquer) and supracapsular technique (Subluxation) will be used equally.

Interventions

Phacoemulsification

Endocapsular technique (Divide-and-conquer) and supracapsular technique (Subluxation) will be used equally.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Marc Perone, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Metz Thionville Hopital de Mercy

Locations

CHR Metz-Thionville/Hopital Mercy

Metz, Grand Est, France

CHR Metz-Thionville_Hopital Bel Air

Thionville, Grand Est, France

Countries

France

Other Identifiers

2021-04-CHRMT

Identifier Type: -

Identifier Source: org_study_id