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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00744666
Acronym
IVTA:PRE-TREAT
Enrollment
70
Registered
2008-09-01
Start date
2008-09-30
Completion date
2010-07-31
Last updated
2009-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Vitreoretinal Disease

Keywords

Intravitreal triamcinolone acetonide, Side-effects, Ocular hypertension, Glaucoma, Prevention, Vitreoretinal diseases requiring IVTA for treatment

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.

Interventions

DRUGPrednisolone 1% topical eye drops

Prednisolone 1% 1gtt qid to the eye requiring IVTA

Sponsors

Sunnybrook Health Sciences Centre
CollaboratorOTHER
Hotel Dieu Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Visual AcuityMonthly for 6 months
Incidence of other complications (cataract, retinal detachment, endophthalmitis)Monthly for 6 months

Countries

Canada

Contacts

Primary ContactKenneth Eng, MD, FRCSC
kt_eng@hotmail.com416-480-4468
Backup ContactJeffery Gale, MD, FRCSC
jeffgaleuwo@yahoo.com613-544-3400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026