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OpenTrials
Completed

NCT Number: NCT05265832

Influencing Factors of the Corneal Endothelial Cell Loss

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR Metz-Thionville/Hopital Mercy, Metz, Grand Est, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

phacoemulsification

Procedure

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

Primary outcomes

  1. Postoperative endothelial cell loss

    Time frame: Month 3

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

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

Acronym: PREDICS

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 4, 2022
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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