Recruiting

IntraVitreal Triamcinolone Acetonide

Sponsor:

Hotel Dieu Hospital

Code:

NCT00744666

Conditions

Vitreoretinal Disease

Ocular Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prednisolone 1% topical eye drops

Study Details

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.

Conditions

Vitreoretinal Disease

Ocular Hypertension

Study ID

NCT00744666

Start date

Sep, 2008

Status verified date

Aug, 2009

Completion date

Jul, 2010

Anticipated

Primary completion date

Jun, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

no intervention: 2

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

Interventions

Prednisolone 1% topical eye drops

Prednisolone 1% 1gtt qid to the eye requiring IVTA

Primary outcome measure

  • 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. [ Time Frame: Monthly for 6 months ]

Central Contacts and Locations

Central contacts

Kenneth Eng, MD, FRCSC

416-480-4468kt_eng@hotmail.com

Jeffery Gale, MD, FRCSC

613-544-3400jeffgaleuwo@yahoo.com

Locations

Hotel Dieu Hospital

Recruiting

Kingston, Ontario, Canada, K7L 5G2

Contacts

Jeffery Gale, MD, FRCSC

613-544-3400jeffgaleuwo@yahoo.com

Principal Investigator:

Jeffery Gale, MD, FRCSC

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

Kenneth Eng, MD, FRCSC

416-480-4688kt_eng@hotmail.com

Principal Investigator:

Kenneth Eng, MD, FRCSC

More Information

Sponsor

Hotel Dieu Hospital

Last update posted

Aug 6, 2009

Last verified

Aug, 2009

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hotel Dieu Hospital on 2009-08-06.