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Quantification of Factors Influencing Endothelial Damage During Phacoemulsification

Research and Quantification of Factors Influencing Endothelial Damage During Phacoemulsification

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05529485
Acronym
PREDICSPILOT
Enrollment
121
Registered
2022-09-07
Start date
2022-01-12
Completion date
2022-08-01
Last updated
2022-09-10

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

Conditions

Cataract, Endothelial Cell Loss, Corneal, Phacoemulsification

Brief summary

The aim of this study is to determine the principal factors that influence endothelial cell loss three month post cataract surgery. Methods: Multi center observational Cohort study, inclusion period from 12/01/2022 to 10/06/2022. One hundred and seventy-five eyes of hundred and four patients who have appointment for cataract surgical indication were included. The percentage of corneal endothelial cell loss was quantified using specular microscopy before and 3 months after the surgery. 14 variables (pre-operative and intra-operative) that could be associated to endothelial cell injury were selected. A bivariate analysis of relationship between these factors and endothelial cell loss at 3 months was performed by simple linear regression (Wilcoxon and Fischer tests). Multivariate analysis was performed by multiple linear regression in order to identify the factors independently related to endothelial cell loss.

Interventions

PROCEDURECataract surgery by phacoemulsification

Cataract surgery by phacoemulsification

Sponsors

Centre Hospitalier Régional Metz-Thionville
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

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
The difference in central corneal endothelial cell density (cells/mm²) between the 1st preoperative measurement and the postoperative measurement at 3 months.3 months after cataract surgerySpecular counts were performed by the orthoptists, residents or physicians of the department using a Nidek CEM-530 specular microscope with automated central cell counting without corneal contact. Three measurements were performed at each consultation and the average of these three measurements was reported.

Secondary

MeasureTime frameDescription
Postoperative visual acuity3 months after cataract surgerybest spectacle corrected visual acuity is evaluated using Monoyer scale, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best.
Postoperative corneal edema3 months after cataract surgeryCorneal edema is measured using specular microscope with pachymeter

Countries

France

Outcome results

None listed

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