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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Hotel Dieu Hospital.
Recruitment status was:  Recruiting
Sunnybrook Health Sciences Centre
Information provided by:
Hotel Dieu Hospital Identifier:
First received: August 29, 2008
Last updated: August 4, 2009
Last verified: August 2009
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 Intervention Phase
Vitreoretinal Disease Ocular Hypertension Drug: Prednisolone 1% topical eye drops Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids

Resource links provided by NLM:

Further study details as provided by Hotel Dieu Hospital:

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. [ Time Frame: Monthly for 6 months ]

Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: Monthly for 6 months ]
  • Incidence of other complications (cataract, retinal detachment, endophthalmitis) [ Time Frame: Monthly for 6 months ]

Estimated Enrollment: 70
Study Start Date: September 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00744666

Contact: Kenneth Eng, MD, FRCSC 416-480-4468
Contact: Jeffery Gale, MD, FRCSC 613-544-3400 ext 3391

Canada, Ontario
Hotel Dieu Hospital Recruiting
Kingston, Ontario, Canada, K7L 5G2
Contact: Jeffery Gale, MD, FRCSC    613-544-3400 ext 3391   
Sub-Investigator: Christina Leung, MD         
Principal Investigator: Jeffery Gale, MD, FRCSC         
Sub-Investigator: Delan Jinapriya, MD, FRCSC         
The Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Bernard Hurley, MD, FRCSC    (613) 737-8899 ext 79422   
Principal Investigator: Bernard Hurley, MD, FRCSC         
Sub-Investigator: Sylvia Chen, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Kenneth Eng, MD, FRCSC    416-480-4688   
Sub-Investigator: Peter Kertes, MD, FRCSC         
Sub-Investigator: Carol Schwartz, MD, FRCSC         
Sub-Investigator: Daniel Weisbrod, MD, FRCSC         
Principal Investigator: Kenneth Eng, MD, FRCSC         
Toronto Western Hospital Not yet recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Brent Michael, MD, FRCSC    416-603-5444   
Principal Investigator: Michael Brent, MD, FRCSC         
Sub-Investigator: Chirag Shah, MD, FRCSC         
Sub-Investigator: Patrick Santiago, MD, FRCSC         
Sponsors and Collaborators
Hotel Dieu Hospital
Sunnybrook Health Sciences Centre
Principal Investigator: Kenneth Eng, MD, FRCSC Sunnybrook Health Sciences Centre
Principal Investigator: Jeffery Gale, MD, FRCSC Hotel Dieu Hospital
  More Information

Responsible Party: Dr. Kenneth Eng, Sunnybrook Health Sciences Centre Identifier: NCT00744666     History of Changes
Other Study ID Numbers: 07142008
Study First Received: August 29, 2008
Last Updated: August 4, 2009

Keywords provided by Hotel Dieu Hospital:
Intravitreal triamcinolone acetonide
Ocular hypertension
Vitreoretinal diseases requiring IVTA for treatment

Additional relevant MeSH terms:
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Prednisolone acetate
Methylprednisolone acetate
Triamcinolone hexacetonide
Methylprednisolone Hemisuccinate
Triamcinolone Acetonide
Prednisolone hemisuccinate
Prednisolone phosphate
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Immunosuppressive Agents processed this record on July 19, 2017