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OpenTrials
Completed

NCT Number: NCT03689270

Corneal Edema After Phacoemulsification

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subluxation

Procedure

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

Procedure

Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration

Primary outcomes

  1. Corneal edema preoperative

    Time frame: Day 1

    Central corneal thickness measurements were taken preoperatively

Secondary outcomes

  1. Corneal edema postoperative

    Time frame: Day 4

    Central corneal thickness measurements were taken postoperative day 4

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

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

Acronym: COPHA

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 28, 2018
Registry last updated
Sep 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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