Influencing Factors of the Corneal Endothelial Cell Loss (PREDICS)

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Procedure: Phacoemulsification

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.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grand Est
    • Thionville, Grand Est, France
      • CHR Metz-Thionville_Hopital Bel Air
  • Grand-Est
    • Metz, Grand-Est, France, 57085
      • CHR Metz-Thionville/Hopital Mercy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Jean Marc Perone, MD, CHR Metz Thionville Hopital de Mercy

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2022
• Primary Completion (Actual): October 17, 2022
• Study Completion (Actual): September 4, 2023

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Endothelial cell loss
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Postoperative Complications; Lens Diseases; Corneal Diseases; Eye Manifestations; Cataract; Corneal Endothelial Cell Loss
• Other Study ID Numbers: 2021-04-CHRMT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No