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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03685825
Other study ID # 2015-14Obs-CHRMT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2013
Est. completion date March 31, 2014

Study information

Verified date August 2018
Source Centre Hospitalier Régional Metz-Thionville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To assess the impact of surgeon experience on early postoperative central corneal thickness (CCT) in eyes that have undergone phacoemulsification-based cataract surgery.


Description:

Cataract surgery is the most commonly performed surgical procedure. Although phacoemulsification is considered a safe method of performing cataract surgery, the risk of endothelial cell loss (ECL) remains.

Given that the surgical technique and speed typically improve with surgeon skill and experience, the purpose of this study was to evaluate the impact of surgeon experience on the occurrence of ECL, as reflected by the presence of corneal edema.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date March 31, 2014
Est. primary completion date January 1, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Presence of senile cataract

- Age above 50 years

- History of visual acuity regression

Exclusion Criteria:

- Presence of white or Brown cataract

- History of previous ophtalmic surgery

- preexisting corneal pathology (cornea guttata, infectious keratitis or active inflammatory or old)

- Patients who developed intraoperative complications

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville

Outcome

Type Measure Description Time frame Safety issue
Primary Early postoperative corneal edema Calculated in micrometers, using pachymetric measurements to estimate central corneal thickness hour 2
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