NCT03972670

Brief Summary

To study correlation between postoperative corneal edema and endothelial cell loss after cataract surgery by microcoaxial phacoemulsification.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2014

Typical duration 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

August 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2014

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
Last Updated

June 4, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

May 31, 2019

Last Update Submit

May 31, 2019

Conditions

CataractPhacoemulsification

Outcome Measures

Primary Outcomes (1)

  • Pachymetry

    Measurement of the thickness of the eye's cornea with a pachymeter

    Day 1

Secondary Outcomes (3)

  • Endothelial cell density

    Day 1

  • Pachymetry after 1 month

    Day 30

  • Endothelial cell density after 1 month

    Day 30

Eligibility Criteria

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

All patients undergoing surgery were older than 18 years. Subjects had cataract up to C5, N4 and P5 on the LOCS III classification

You may qualify if:

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

You may not qualify if:

  • Patient with total white cataract
  • With history of ocular surgery
  • With other eye diseases (corneal pathology, Fuchs dystrophy, uveitis and glaucoma) or systemic diseases (diabetic disorder and dementia)

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

May 31, 2019

First Posted

June 4, 2019

Study Start

August 1, 2014

Primary Completion

November 30, 2014

Study Completion

January 1, 2018

Last Updated

June 4, 2019

Record last verified: 2019-05