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CompletedNCT03689270COPHAUpdated Sep 28, 2018

Corneal Edema After Phacoemulsification

An observational study in Cataract, sponsored by Centre Hospitalier Régional Metz-Thionville. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-28.

Sponsored by Centre Hospitalier Régional Metz-Thionville · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
96
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Cataract

Keywords

  • subluxation
  • Divide and conquer
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In context

Cataract

1,726 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 96 is above the median of 82 across 491 observational studies indexed under Cataract.

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Lead sponsor

Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 123 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
96 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Divide and Conquer

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

    Procedure: Divide and conquer

Interventions

  • ProcedureSubluxation

    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.

  • ProcedureDivide and conquer

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

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What researchers measure

Primary outcomes

  1. Corneal edema preoperative

    Central corneal thickness measurements were taken preoperatively

    Time frame: Day 1

Secondary outcomes

  1. Corneal edema postoperative

    Central corneal thickness measurements were taken postoperative day 4

    Time frame: Day 4

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03689270
Responsible party
Sponsor
First posted
Sep 28, 2018
Start date
Jan 2015
Primary completion
Jul 2015
Completion
Dec 2015
Last update
Sep 28, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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