Clinical trial NCT00744666: IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids
Official title: IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vitreoretinal Disease
Ocular Hypertension
Keywords: Intravitreal triamcinolone acetonide
Side-effects
Ocular hypertension
Glaucoma
Prevention
Vitreoretinal diseases requiring IVTA for treatment
Lead sponsor: Hotel Dieu Hospital
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
First posted: 2008-09-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Intravitreal triamcinolone acetonide (IVTA) is a commonly employed treatment for various vitreoretinal disorders. However, approximately 23% to 50% of patients who receive IVTA develop ocular hypertension after the drug is injected into the eye. Similar to IVTA, topically administered corticosteroids eye drops result in ocular hypertension in approximately 33% of the population. It is unknown whether identifying patients who develop ocular hypertension from topical corticosteroids could be used to identify patients who are at risk for injectable IVTA. Therefore, the purpose of this study is to evaluate the efficacy of topical prednisolone 1% four times daily for one month as a screening test to reduce the incidence and severity of ocular hypertension after IVTA injection.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with vitreoretinal disease for which IVTA has been chosen as treatment

Exclusion Criteria:

* \< 18 years old
* Pregnancy
* Breast feeding
* hx of uveitis
* hx of neovascularization of the iris or anterior chamber angle
* hx of ocular herpes simplex keratitis
* hx of glaucoma
* Unable to provide informed consent

Primary outcomes:
measure: To detect a 60% or greater decrease of developing ocular hypertension (>20 mmHg) in the group of patients who received a trial of prednisolone 1% gtts x 4 weeks, compared the group who did not receive a trial of topical prednisolone.
timeFrame: Monthly for 6 months
Secondary outcomes:
measure: Visual Acuity
timeFrame: Monthly for 6 months
measure: Incidence of other complications (cataract, retinal detachment, endophthalmitis)
timeFrame: Monthly for 6 months
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Kenneth Eng, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Hotel Dieu Hospital
name: Jeffery Gale, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jonas JB, Kreissig I, Degenring R. Intraocular pressure after intravitreal injection of triamcinolone acetonide. Br J Ophthalmol. 2003 Jan;87(1):24-7. doi: 10.1136/bjo.87.1.24.