NCT00767884

Brief Summary

The purpose of this study is to evaluate the optic nerve head changes consequent to panretinal photocoagulation done for diabetic retinopathy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

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

October 3, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
22 days until next milestone

Study Start

First participant enrolled

October 29, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2013

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

5 years

First QC Date

October 3, 2008

Last Update Submit

August 19, 2023

Conditions

Diabetic Retinopathy

Keywords

panretinal photocoagulationdiabetic retinopathyoptic nerve head changes

Outcome Measures

Primary Outcomes (1)

  • Changes in optic nerve head topography before and after panretinal photocoagulation

    Compare changes in optic nerve head topography before and after panretinal photocoagulation (PRP)

    3 years

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ophthalmology Clinic at UNMC

You may qualify if:

  • Any patient with proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy otherwise undergoing panretinal photocoagulation for treatment.

You may not qualify if:

  • Any patient with uncontrolled glaucoma (IOP above target on any occasion in the preceding 6 months) or other optic neuropathy that may confound the analysis of optic nerve head morphology.
  • Patients with media opacities (significant cataract, corneal opacity, vitreous hemorrhage) precluding imaging of the optic nerve.
  • No PRP done in the previous 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UNMC Truhlsen Eye Institute

Omaha, Nebraska, 68105, United States

Location

University of Nebraska Medical Center Eye Clinic

Omaha, Nebraska, 68198-5540, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Vikas Gulati, MD

    UNMC

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 7, 2008

Study Start

October 29, 2008

Primary Completion

October 17, 2013

Study Completion

October 17, 2013

Last Updated

August 23, 2023

Record last verified: 2023-08

Locations

US(2)