NCT03685825

Brief Summary

To assess the impact of surgeon experience on early postoperative central corneal thickness (CCT) in eyes that have undergone phacoemulsification-based cataract surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2014

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
Last Updated

September 26, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

September 25, 2018

Last Update Submit

September 25, 2018

Conditions

Cataract

Keywords

Surgeon experienceEndothelial cell loss

Outcome Measures

Primary Outcomes (1)

  • Early postoperative corneal edema

    Calculated in micrometers, using pachymetric measurements to estimate central corneal thickness

    hour 2

Eligibility Criteria

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

One hundred sixty eyes underwent phacoemulsification-based cataract surgery performed by an experienced surgeon or a less surgically experienced ophtalmic assistant, using the divide-and-conquer or tilt-and-tumble technique for cataractous lens extraction.

You may qualify if:

  • Presence of senile cataract
  • Age above 50 years
  • History of visual acuity regression

You may not qualify if:

  • Presence of white or Brown cataract
  • History of previous ophtalmic surgery
  • preexisting corneal pathology (cornea guttata, infectious keratitis or active inflammatory or old)
  • Patients who developed intraoperative complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

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

Study Record Dates

First Submitted

September 25, 2018

First Posted

September 26, 2018

Study Start

October 1, 2013

Primary Completion

January 1, 2014

Study Completion

March 31, 2014

Last Updated

September 26, 2018

Record last verified: 2018-08