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Influencing Factors of the Corneal Endothelial Cell Loss

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05265832
Acronym
PREDICS
Enrollment
154
Registered
2022-03-04
Start date
2022-05-04
Completion date
2023-09-04
Last updated
2023-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Endothelial cell loss

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.

Interventions

PROCEDUREPhacoemulsification

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

Sponsors

Centre Hospitalier Régional Metz-Thionville
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative endothelial cell lossMonth 3Difference in endothelial cell density between preoperative measurements and 3 months after surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026