IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids (IVTA:PRE-TREAT)

Hotel Dieu Hospital

Status and phase: Unknown; Phase 4

Conditions: Ocular Hypertension; Vitreoretinal Disease

Treatments: Drug: Prednisolone 1% topical eye drops

Study type: Interventional

Funder types: Other

Identifiers

NCT00744666

07142008

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Drug: Prednisolone 1% topical eye drops

2

No Intervention group

Description:

Patients will receive an injection of IVTA (no trial of Prednisolone gtts is given).