Corneal Edema After Phacoemulsification

Completed

• Conditions: Cataract
• Interventions: Procedure: Divide and conquer; Procedure: Subluxation

• Registration Number: NCT03689270
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

Brief Summary

To compare the impact of two phacoemulsification techniques (subluxation versus divide-and-conquer) on postoperative corneal edema at postoperative hour 1 and day 4.

Detailed Description

Phacoemulsification is the procedure of choice for most surgeons performing cataract surgery. Alternative techniques have been in development over the last twenty years, with the hope of optimizing operating times, total ultrasound energy used, patient safety, patient satisfaction and visual recovery associated with cataract surgery.

Divide-and conquer is the parent nucleofracture technique.The subluxation technique is a newer technique that is less frequently used because of an increased risk of corneal endothelium damage.

The aim of this comparative study was to evaluate corneal edema immediately after surgery performed with the subluxation technique versus divide-and-conquer. Corneal edema was determined by measuring central corneal thickness (CCT).

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-07
• Study Completion: 2015-12
• Status Verified: 2018-08
• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-09-26
• Last Update Submitted: 2018-09-26
• Study First Posted: 2018-09-28
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

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

Exclusion Criteria

• Patients with total white cataract
• With history of ocular surgery and other eye diseases (corneal pathology, uveitis, glaucoma)
• With systemic diseases with the potential to affect vision

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Divide and Conquer	Divide and conquer	Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration
Subluxation	Subluxation	Nucleus is hydrodissected until it lilts above the capsular bag, rotated to face the incision then tumbled and emulsification continues from the opposite equator outside in until complete

Primary Outcome Measures

Name	Time	Method
Corneal edema preoperative	Day 1	Central corneal thickness measurements were taken preoperatively

Secondary Outcome Measures

Name	Time	Method
Corneal edema postoperative	Day 4	Central corneal thickness measurements were taken postoperative day 4