NCT00229931

Brief Summary

The purpose of this study is to determine if intravitreal triamcinolone acetonide (IVTA) injection at the time of cataract surgery will improve visual acuity and decrease post-operative swelling in diabetic patients requiring cataract extraction as compared to the conventional treatment of laser following cataract surgery. The subjects will be followed for 11 visits over 3 year. Visits will occur at screening,1, 3,6,9,12,18,24,30 and 36 months post surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

September 28, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

July 28, 2017

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

7.5 years

First QC Date

September 28, 2005

Results QC Date

April 10, 2017

Last Update Submit

December 8, 2023

Conditions

DIABETIC MACULAR EDEMA

Keywords

CATARACT EXTRACTIONMACULAR EDEMADIABETESFOCAL LASERTRIAMCINOLONE

Outcome Measures

Primary Outcomes (1)

  • Main Outcome Measures Will be Quantitative Changes in OCT Central Thickness, Visual Acuity, and Number of Snellen Acuity Lines Gained/Lost.

    3 years

Secondary Outcomes (1)

  • Rate of Elevated Intraocular Pressures, Retinal Detachment, Infection, and Vitreous Hemorrhage.

    3 years

Study Arms (2)

Laser therapy

ACTIVE COMPARATOR

If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.

Procedure: laser

Triamcinolone therapy

ACTIVE COMPARATOR

At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered "treatment failure" and will be given the option to have laser therapy.

Drug: Triamcinolone acetonide

Interventions

Triamcinolone acetonideDRUG

4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response

Also known as: Kenalog
Triamcinolone therapy
laserPROCEDURE

Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.

Also known as: focal laser photocoagulation
Laser therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • visually significant cataracts
  • pre-operative visual acuity 20/50 or worse
  • pre-operative optical coherence tomography (OCT) showing at least 250 microns central foveal thickness.

You may not qualify if:

  • macular ischemia
  • vitreomacular traction
  • macular hole

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dean A. McGee Eye Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Related Links

MeSH Terms

Conditions

Macular EdemaDiabetes Mellitus

Interventions

Triamcinolone AcetonideLasers

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Limitations and Caveats

Due to lack of patient follow up on this study, sufficient data was not available for analysis

Results Point of Contact

Title
Robert E. Leonard, II, MD
Organization
Dean McGee Eye Institute
sonny-icks@dmei.org
405-271-6307

Study Officials

  • Robert E Leonard, MD

    Dean A. McGee Eye Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2005

First Posted

September 30, 2005

Study Start

November 1, 2005

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

December 28, 2023

Results First Posted

July 28, 2017

Record last verified: 2023-12

Locations

US(1)