PREDICS: Influencing Factors of the Corneal Endothelial Cell Loss

Sponsor

Centre Hospitalier Régional Metz-Thionville (Other)

Overall Status

Recruiting

CT.gov ID

NCT05265832

Collaborator

(none)

144

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: Phacoemulsification	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 4, 2022

Anticipated Primary Completion Date :

Aug 4, 2023

Anticipated Study Completion Date :

Nov 4, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Cataract surgery

Phacoemulsification cataract surgery

Procedure: Phacoemulsification

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

Outcome Measures

Primary Outcome Measures

Postoperative endothelial cell loss [Month 3]
Difference in endothelial cell density between preoperative measurements and 3 months after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing cataract surgery
Visual acuity monoyer scale <6/10e (> +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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHR Metz-Thionville/Hopital de Mercy	Metz	Grand-Est	France	57085

Sponsors and Collaborators

Centre Hospitalier Régional Metz-Thionville

Investigators

Principal Investigator: Jean Marc Perone, MD, CHR Metz Thionville Hopital de Mercy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Régional Metz-Thionville

ClinicalTrials.gov Identifier:

NCT05265832

Other Study ID Numbers:

2021-04-CHRMT

First Posted:

Mar 4, 2022

Last Update Posted:

May 6, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Régional Metz-Thionville

Endothelial cell loss

Additional relevant MeSH terms:

Cataract

Corneal Endothelial Cell Loss

Study Results

No Results Posted as of May 6, 2022