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| Name | Class |
|---|---|
| Sunnybrook Health Sciences Centre | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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. |
|
| 2 | No Intervention | Patients will receive an injection of IVTA (no trial of Prednisolone gtts is given). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone 1% topical eye drops | Drug | Prednisolone 1% 1gtt qid to the eye requiring IVTA |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Monthly for 6 months | |
| Incidence of other complications (cataract, retinal detachment, endophthalmitis) | Monthly for 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Eng, MD, FRCSC | Contact | 416-480-4468 | kt_eng@hotmail.com | |
| Jeffery Gale, MD, FRCSC | Contact | 613-544-3400 | 3391 | jeffgaleuwo@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Kenneth Eng, MD, FRCSC | Sunnybrook Health Sciences Centre | Principal Investigator |
| Jeffery Gale, MD, FRCSC | Hotel Dieu Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel Dieu Hospital | Recruiting | Kingston | Ontario | K7L 5G2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12488256 | Background | Jonas JB, Kreissig I, Degenring R. Intraocular pressure after intravitreal injection of triamcinolone acetonide. Br J Ophthalmol. 2003 Jan;87(1):24-7. doi: 10.1136/bjo.87.1.24. |
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| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| The Ottawa Hospital | Not yet recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
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| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N3M5 | Canada |
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| Toronto Western Hospital | Not yet recruiting | Toronto | Ontario | M5T 2S8 | Canada |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |