Corneal Edema After Phacoemulsification (COPHA)

September 26, 2018 updated by: Centre Hospitalier Régional Metz-Thionville

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

96

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Patients underwent phacoemulsification cataract surgery over a 6-month period.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Procedure: Divide and conquer
Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal edema preoperative
Time Frame: Day 1
Central corneal thickness measurements were taken preoperatively
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal edema postoperative
Time Frame: Day 4
Central corneal thickness measurements were taken postoperative day 4
Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional Metz-Thionville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (ACTUAL)

September 28, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2018

Last Update Submitted That Met QC Criteria

September 26, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-12Obs-CHMRT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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