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Topical vs Oral agents to lower intra-ocular pressure following cataract surgery (Acetazolamide vs Brimonidine)

Among patients who undergo phacoemulsification cataract surgery, is a single dose of topical brimonidine as effective, or more effective than a single dose of oral acetazolamide to lower intra-ocular pressure, post-operatively?

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000553279
Acronym
TOLIOP
Enrollment
56
Registered
2009-07-08
Start date
2009-07-09
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Tragically, one patient in this state recently suffered a fatal outcome following a severe allergic reaction to acetazolamide, a routine post-operative oral tablet used following cataract surgery to combat increases in the amount of fluid pressure within the operated eye. If not controlled, this increase in pressure can lead to damage to the optic nerve and retinal artery and vein occlusion in susceptible patients. There have been 2 similar cases of severe allergic reactions to acetazolamide reported in the medical literature. A survey of consultants in the United Kingdom found that 83% of surgeons who routinely prescribed pressure lowering medications used acetazolamide. We propose to investigate the use of brimonidine, a topical agent in a case-control study vs. oral acetazolamide in patients who have undergone phacoemulsification cataract surgery. We hypothesise that this topical agent will have a similar or superior efficacy in controlling ocular hypertension, whilst avoiding potentially serious systemic adverse effects. It is hoped that this may provide the impetus for change in clinical practice, where currently, the majority of patients are prescribed oral acetazolamide. To our knowledge, such a study comparing single dose use of these medications has not been published.

Interventions

1) Brimonidine 0.2%, 1 eye drop immediately post operatively. 2)Oral acetazolamide, single dose 250mg tablet immediately post op.

Sponsors

Sir Charles Gairdner Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

Phaco emulsification cataract surgery performed under local anaesthesia

Exclusion criteria

Glaucoma. Use of any agent designed to lower intra ocular pressure Previous ocular surgery on the study eye. Known allergic reactions to sulphonamides

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026