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CompletedNCT00478764Updated May 25, 2007

Intraocular Steroid After Cataract Surgery Study

An interventional study of intraocular triamcinolone and gatifloxicin in Cataract, sponsored by Dean Health System. Completed at 1 site in United States. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-05-25.

Sponsored by Dean Health System · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

The use of one dose of an antibiotic and steroid injected into the eye at the end of cataract surgery is as safe and effective as the post operative use of eyedrops after cataract surgery.

Read the detailed description

This prospective randomized controlled trial included 80 eyes of 40 patients having routine phacoemulsification of cataract. Patients between 40 and 80 years of age who met enrollment criteria, required cataract surgery in both eyes, and agreed to participate, were enrolled in the study over a nine month period in 2006 at the office of one cataract surgeon. Eyes were randomly assigned to receive either the eye drop or injection protocol on the initial consultative visit. All surgery was preformed by one surgeon (JGS) using topical anesthesia, the Infiniti phacoemulsification system (Alcon) and an Acrysof SN60WF (Alcon) intraocular lens. The fellow eye was operated upon using the same technique and instrumentation two weeks later and was assigned to the group opposite the first eye. All eyes were examined by the operating surgeon at days 1, 8, 15, 30 and 90 postoperatively with uncorrected visual acuity, best corrected visual acuity, intraocular pressure, corneal edema, anterior chamber cell and flare recorded.

02

Conditions studied

  • Cataract

Keywords

  • intraocular
  • triamcinolone
  • gatifloxicin
  • inflammation
  • visual acuity
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 41 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

This is the only study on the registry with Dean Health System as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Inclusion criteria for patients to enter the study included age 40 to 80 years, clinically significant cataract in both eyes, the patient's willingness to enter the study and have cataract surgery preformed on each eye in a sequentially within a two or three week time frame.

Exclusion criteria

Exclusion Criteria:

  • Exclusion criteria included a history of glaucoma, retinopathy of any type, pseudoexfoliation, other significant ocular co morbidity and systemic diabetes.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (actual)

Interventions

  • Drugintraocular triamcinolone and gatifloxicin
06

What researchers measure

Primary outcomes

  1. visual acuity

    Time frame: 90 days

Secondary outcomes

  1. intraocular inflammation

    Time frame: 90 days

07

Study locations

1 site
  • Davis Duehr Dean Baraboo
    Baraboo, Wisconsin 53913, United States
08

References and documents

Publications

  • Gills JP, Gills P. Effect of intracameral triamcinolone to control inflammation following cataract surgery. J Cataract Refract Surg. 2005 Aug;31(8):1670-1. doi: 10.1016/j.jcrs.2005.07.023. No abstract available. PubMed 16129313 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00478764
Lead sponsor
Dean Health System
First posted
May 25, 2007
Start date
Mar 2006
Completion
Apr 2007
Last update
May 25, 2007

Study contacts

Jonathan G Stock, MD
principal investigator · Dean Health Systems

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2007. You cannot join it, but the record below documents what was studied.

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