Trials / Completed
CompletedNCT05265832
Influencing Factors of the Corneal Endothelial Cell Loss
Identification of Factors That Influence the Corneal Endothelial Cell Loss During Phacoemulsification
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 154 (actual)
- Sponsor
- Centre Hospitalier Régional Metz-Thionville · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Phacoemulsification | Endocapsular technique (Divide-and-conquer) and supracapsular technique (Subluxation) will be used equally. |
Timeline
- Start date
- 2022-05-04
- Primary completion
- 2022-10-17
- Completion
- 2023-09-04
- First posted
- 2022-03-04
- Last updated
- 2023-12-26
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05265832. Inclusion in this directory is not an endorsement.