NCT02548273

Brief Summary

This study aims to assess the corneal damage after phacoemulsification and to assess the factors causing it in diabetics in comparison with non-diabetics.

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 Jan 2013

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

January 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
Last Updated

September 14, 2015

Status Verified

September 1, 2015

Enrollment Period

1.1 years

First QC Date

September 9, 2015

Last Update Submit

September 10, 2015

Conditions

Diabetes Mellitus

Keywords

Corneal endotheliumphacoemulsification

Outcome Measures

Primary Outcomes (4)

  • CHANGE FROM BASELINE IN CORNEAL ENDOTHELIAL CELL DENSITY AT 3 MONTHS

    3 MONTHS

  • CHANGE FROM BASELINE IN COEFFICIENT OF VARIATION OF CELL SIZE AT 3 MONTHS

    3 MONTHS

  • CHANGE FROM BASELINE IN CORNEAL ENDOTHELIAL CELL HEXAGONALITY AT 3 MONTHS

    expressed as %

    3 MONTHS

  • CHANGE FROM BASELINE IN CENTRAL CORNEAL THICKNESS AT 3 MONTHS

    3 MONTHS

Study Arms (2)

Diabetics

diabetics with cataract who opted for phacoemulsification surgery

controls

non-diabetics with cataract who opted for phacoemulsification surgery (subjects without corneal opacity, PXF ,high myopia, uveitis)

Eligibility Criteria

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

Patients attending the Ophthalmology OPD, JIPMER

You may qualify if:

  • \. Diabetic patients with age-related cataract planned for phacoemulsification.

You may not qualify if:

  • Patients undergoing cataract surgery (Other than phacoemulsification)
  • High myopia (\> -6D)
  • Presence of corneal opacities
  • Presence of pseudoexfoliation
  • Presence of uveitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • NIRUBAN GANESAN, MBBS, MS

    Jawaharlal Institute of Postgraduate Medical Education & Research

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 9, 2015

First Posted

September 14, 2015

Study Start

January 1, 2013

Primary Completion

February 1, 2014

Study Completion

June 1, 2014

Last Updated

September 14, 2015

Record last verified: 2015-09