NCT05522842

Brief Summary

evaluate and compare the changes in corneal endothelial cell count density between diabetic and non diabetic patients undergoing phacoemulsification surgery, and to evaluate the effect of duration, and control of diabetes on corneal morphology.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Status
unknown

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

First Submitted

Initial submission to the registry

August 13, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 21, 2023

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

August 13, 2022

Last Update Submit

February 18, 2023

Conditions

Corneal Endothelial Cell Loss

Outcome Measures

Primary Outcomes (3)

  • corneal endothelium cell count

    normal range of 1500 to 3500 cells/mm2 (age, 40-90)

    baseline

  • corneal endothelial cell size

    their dimension being roughly 50-70 μm long, 10-30 μm wide and 0.1-10 μm thick

    baseline

  • corneal endothelial cell shape

    a single layer of cells organized in a characteristic honeycomb pattern

    baseline

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

evaluate the changes in corneal endothelium between 50 patients diabetic and non diabetic undergoing phacoemulsification

You may qualify if:

  • Age from 40 to 70
  • Any degree of cataract
  • No previous ocular surgery

You may not qualify if:

  • Any corneal pathology, infection, or active inflammation
  • pseudoexofoliation
  • History of ocular trauma or surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Corneal Endothelial Cell Loss

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesEye ManifestationsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

August 13, 2022

First Posted

August 31, 2022

Study Start

November 1, 2023

Primary Completion

November 1, 2024

Study Completion

March 1, 2025

Last Updated

February 21, 2023

Record last verified: 2022-09