Corneal Edema After Phacoemulsification

Cataract Clinical Trial

— COPHA  

Official title:

Central Corneal Thickness Assessment After Phacoemulsification: Subluxation Versus Divide-and-Conquer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689270
• Other study ID #: 2015-12Obs-CHMRT
• Status: Completed
• Start date: January 2015
• Est. completion date: December 2015

Study information

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

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Subluxation
One pole of The nucleus is hydrodissected until it lilts above the capsular bag. The tilted nucleus is rotated to face the incision and remaining half nucleus is then tumbled and emulsification continues from the opposite equator outside in until complete.
• Divide and conquer
Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration

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	Corneal edema preoperative	Central corneal thickness measurements were taken preoperatively	Day 1
Secondary	Corneal edema postoperative	Central corneal thickness measurements were taken postoperative day 4	Day 4