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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vitreoretinal Disease, Ocular Hypertension

Intervention / Treatment
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* Drug: Prednisolone 1% topical eye drops


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Drug: Prednisolone 1% topical eye drops<br>* Prednisolone 1% 1gtt qid to the eye requiring IVTA<br>|
| No Intervention: 2<br>Patients will receive an injection of IVTA (no trial of Prednisolone gtts is given). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity |  | Monthly for 6 months | 
| Incidence of other complications (cataract, retinal detachment, endophthalmitis) |  | Monthly for 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravitreal triamcinolone acetonide, Side-effects, Ocular hypertension, Glaucoma, Prevention, Vitreoretinal diseases requiring IVTA for treatment