NCT05265832

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 4, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2023

Completed
Last Updated

December 26, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

February 23, 2022

Last Update Submit

December 20, 2023

Conditions

Cataract

Keywords

Endothelial cell loss

Outcome Measures

Primary Outcomes (1)

  • Postoperative endothelial cell loss

    Difference in endothelial cell density between preoperative measurements and 3 months after surgery

    Month 3

Study Arms (1)

Cataract surgery

EXPERIMENTAL

Phacoemulsification cataract surgery

Procedure: Phacoemulsification

Interventions

PhacoemulsificationPROCEDURE

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

Cataract surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHR Metz-Thionville/Hopital Mercy

Metz, Grand Est, 57085, France

Location

CHR Metz-Thionville_Hopital Bel Air

Thionville, Grand Est, France

Location

MeSH Terms

Conditions

Cataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Jean Marc Perone, MD

    CHR Metz Thionville Hopital de Mercy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2022

First Posted

March 4, 2022

Study Start

May 4, 2022

Primary Completion

October 17, 2022

Study Completion

September 4, 2023

Last Updated

December 26, 2023

Record last verified: 2023-11

Locations

FR(2)