NCT03689270

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
Last Updated

September 28, 2018

Status Verified

August 1, 2018

Enrollment Period

6 months

First QC Date

September 25, 2018

Last Update Submit

September 26, 2018

Conditions

Cataract

Keywords

subluxationDivide and conquer

Outcome Measures

Primary Outcomes (1)

  • Corneal edema preoperative

    Central corneal thickness measurements were taken preoperatively

    Day 1

Secondary Outcomes (1)

  • Corneal edema postoperative

    Day 4

Study Arms (2)

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

SubluxationPROCEDURE

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.

Subluxation
Divide and conquerPROCEDURE

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

Divide and Conquer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CataractJoint Dislocations

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesJoint DiseasesMusculoskeletal DiseasesWounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2018

First Posted

September 28, 2018

Study Start

January 1, 2015

Primary Completion

July 1, 2015

Study Completion

December 1, 2015

Last Updated

September 28, 2018

Record last verified: 2018-08