Influencing Factors of the Corneal Endothelial Cell Loss (PREDICS)
Primary Purpose
Cataract
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Phacoemulsification
Sponsored by
About this trial
This is an interventional prevention trial for Cataract focused on measuring Endothelial cell loss
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
Sites / Locations
- CHR Metz-Thionville/Hopital de MercyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cataract surgery
Arm Description
Phacoemulsification cataract surgery
Outcomes
Primary Outcome Measures
Postoperative endothelial cell loss
Difference in endothelial cell density between preoperative measurements and 3 months after surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT05265832
First Posted
February 23, 2022
Last Updated
March 8, 2023
Sponsor
Centre Hospitalier Régional Metz-Thionville
1. Study Identification
Unique Protocol Identification Number
NCT05265832
Brief Title
Influencing Factors of the Corneal Endothelial Cell Loss
Acronym
PREDICS
Official Title
Identification of Factors That Influence the Corneal Endothelial Cell Loss During Phacoemulsification
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2022 (Actual)
Primary Completion Date
October 17, 2022 (Actual)
Study Completion Date
November 4, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional Metz-Thionville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Endothelial cell loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cataract surgery
Arm Type
Experimental
Arm Description
Phacoemulsification cataract surgery
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification
Intervention Description
Endocapsular technique (Divide-and-conquer) and supracapsular technique (Subluxation) will be used equally.
Primary Outcome Measure Information:
Title
Postoperative endothelial cell loss
Description
Difference in endothelial cell density between preoperative measurements and 3 months after surgery
Time Frame
Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Marc Perone, MD
Phone
387557777
Ext
0033
Email
jm.perone@chr-metz-thionville.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra MARCHIONNI
Phone
387557750
Ext
0033
Email
projet-recherche@chr-metz-thionville.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Marc Perone, MD
Organizational Affiliation
CHR Metz Thionville Hopital de Mercy
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR Metz-Thionville/Hopital de Mercy
City
Metz
State/Province
Grand-Est
ZIP/Postal Code
57085
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arpiné EL NAR, PhD
Phone
0387557766
Ext
0033
Email
a.elnar@chr-metz-thionville.fr
Email
projet-recherche@chr-metz-thionville.fr
First Name & Middle Initial & Last Name & Degree
Jean-Marc PERONE, MD
First Name & Middle Initial & Last Name & Degree
Mohamed ZAIDI, MD
First Name & Middle Initial & Last Name & Degree
Louis LHUILLIER, MD
12. IPD Sharing Statement
Learn more about this trial
Influencing Factors of the Corneal Endothelial Cell Loss
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