IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids

Phase 4

• Conditions: Vitreoretinal Disease; Ocular Hypertension
• Interventions: Drug: Prednisolone 1% topical eye drops

• Registration Number: NCT00744666
• Lead Sponsor: Hotel Dieu Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-29
• Study First Submitted QC: 2008-08-29
• Study Start: 2008-09
• Study First Posted: 2008-09-01
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-04
• Last Update Posted: 2009-08-06
• Primary Completion: 2010-06
• Study Completion: 2010-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Prednisolone 1% topical eye drops	Patients receive Prednisolone 1% 1gtt qid x 4 weeks. If the intraocular pressure (IOP) after the 4 weeks is \> or equal to 21 mmHg, then IVTA will be withheld. If the IOP \< 21mmHg, then patients will receive an injection of IVTA.

Primary Outcome Measures

Name	Time	Method
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.	Monthly for 6 months

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	Monthly for 6 months
Incidence of other complications (cataract, retinal detachment, endophthalmitis)	Monthly for 6 months

Trial Locations

Locations (4)

Hotel Dieu Hospital; 🇨🇦 Kingston, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada