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

Sponsor

Hotel Dieu Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00744666

Collaborator

Sunnybrook Health Sciences Centre (Other)

Enrollment

Locations

Arms

21.9

Duration (Months)

17.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vitreoretinal Disease Ocular Hypertension	Drug: Prednisolone 1% topical eye drops	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Study Start Date :

Sep 1, 2008

Anticipated Primary Completion Date :

Jun 1, 2010

Anticipated Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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 Prednisolone 1% 1gtt qid to the eye requiring IVTA
No Intervention: 2 Patients will receive an injection of IVTA (no trial of Prednisolone gtts is given).

Arm

Intervention/Treatment

Experimental: 1

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

Prednisolone 1% 1gtt qid to the eye requiring IVTA

No Intervention: 2

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

Outcome Measures

Primary Outcome Measures

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

Visual Acuity [Monthly for 6 months]
Incidence of other complications (cataract, retinal detachment, endophthalmitis) [Monthly for 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hotel Dieu Hospital	Kingston	Ontario	Canada	K7L 5G2
2	The Ottawa Hospital	Ottawa	Ontario	Canada	K1H 8L6
3	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N3M5
4	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8