Quantification of Factors Influencing Endothelial Damage During Phacoemulsification

NCT05529485 | Completed

• 1 other identifier: 2022-11Obs-CHRMT
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Cell Loss, Corneal; Cataract; Phacoemulsification

Outcome Measures

Primary Outcomes (1)

• The difference in central corneal endothelial cell density (cells/mm²) between the 1st preoperative measurement and the postoperative measurement at 3 months.

  Specular 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.

  3 months after cataract surgery

Secondary Outcomes (2)

• Postoperative visual acuity

  3 months after cataract surgery

• Postoperative corneal edema

  3 months after cataract surgery

Interventions

Cataract surgery by phacoemulsification PROCEDURE

Cataract surgery by phacoemulsification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cataract surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

Location

MeSH Terms

Conditions

Corneal Endothelial Cell Loss; Cataract

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Lens Diseases

Study Officials

• Jean Marc Perone

  CHR Metz Thionville Hopital de Mercy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: January 12, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: September 10, 2022

Record last verified: 2022-09

Locations

FR (1)