Influencing Factors of the Corneal Endothelial Cell Loss

Cataract Clinical Trial

— PREDICS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05265832
• Other study ID #: 2021-04-CHRMT
• Status: Completed
• Phase: N/A
• Start date: May 4, 2022
• Est. completion date: September 4, 2023

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: September 4, 2023
• Est. primary completion date: October 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Corneal Endothelial Cell Loss

Intervention

Procedure:
• Phacoemulsification
Endocapsular technique (Divide-and-conquer) and supracapsular technique (Subluxation) will be used equally.

Locations

Country	Name	City	State
France	CHR Metz-Thionville/Hopital Mercy	Metz	Grand-Est
France	CHR Metz-Thionville_Hopital Bel Air	Thionville	Grand Est

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative endothelial cell loss	Difference in endothelial cell density between preoperative measurements and 3 months after surgery	Month 3