Correlation Between Postoperative Central Corneal Thickness and Endothelial Damage After Cataract Surgery (ECOCHI)

Correlation Between Postoperative Central Corneal Thickness and Endothelial Damage After Cataract Surgery by Phacoemulsification

To study correlation between postoperative corneal edema and endothelial cell loss after cataract surgery by microcoaxial phacoemulsification.

Study Overview

• Status: Completed
• Conditions: Cataract; Phacoemulsification

Detailed Description

Cataract surgery facilitates improved visual acuity through extraction of an opacified lens, followed by intraocular lens implantation. An average adult cornea has 2000 to 2500 cells/mm2, a count that diminishes with age with a rate of attrition of approximately 0.3% to 0.5% per year. Long-term postoperative corneal transparency depends on the morphological stability and functional integrity of the corneal endothelium. It is well established that all surgical interventions that require entry into the anterior chamber result in some damage to the corneal endothelium.

Endothelial cell loss results in cell hypertrophy to maintain continuity, resulting in a change in endothelium cell density and morphology. Many studies have assessed the impact of various surgical techniques on endothelial damage and numerous studies have investigated the factors influencing endothelial cell loss after phacoemulsification. The goal of this study is to investigate the correlation of postoperative corneal edema with the reduction of endothelial corneal cell density after phacoemulsification.

• Study Type: Observational
• Enrollment (Actual): 85

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing surgery were older than 18 years. Subjects had cataract up to C5, N4 and P5 on the LOCS III classification

Description

Inclusion Criteria:

• The presence of senile cataract with equivalent grades and a history of visual acuity regression

Exclusion Criteria:

• Patient with total white cataract
• With history of ocular surgery
• With other eye diseases (corneal pathology, Fuchs dystrophy, uveitis and glaucoma) or systemic diseases (diabetic disorder and dementia)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pachymetry	Measurement of the thickness of the eye's cornea with a pachymeter	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial cell density	Endothelial cell density measurements with noncontact specular microscope	Day 1
Pachymetry after 1 month	Measurement of the thickness of the eye's cornea with a pachymeter	Day 30
Endothelial cell density after 1 month	Endothelial cell density measurements with noncontact specular microscope	Day 30

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2014
• Primary Completion (ACTUAL): November 30, 2014
• Study Completion (ACTUAL): January 1, 2018

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (ACTUAL): June 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2019
• Last Update Submitted That Met QC Criteria: May 31, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Capsule Opacification
• Other Study ID Numbers: 2018-13Obs-CHRMT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No