MACULAR THICKNESS CHANGES FOLLOWING THE USE OF PROSTAGLANDIN ANALOGUES IN PSEUDOPHAKIC PATIENTS

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000266561

Enrollment

Registered

2006-06-29

Start date

2006-09-10

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

The primary purpose of the protocol is to investigate the effects of prostaglandin analogues on the macular thickness in pseudophakic patients. Hypothesis: 1) The use of prostaglandin analogues in pseudophakic patients changes the macular thickness / 2) The use of prostaglandin analogues in pseudophakic patients does not change the macular thickness

Interventions

Patients that underwent uncomplicated cataract surgery will be randomized to use topical bimatoprost 0.03% eye-drop q.d. (n=10), topical latanoprost 0.005% eye-drop q.d. (n=10), or topical travoprost 0.004% eye-drop q.d. (n=10) for 1 month. Macular thickness will be evaluate using OCT at baseline, 15 days and 1 month. The baseline will be used as control.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients in the study will be subjects that underwent uneventful cataract surgery with intraocular lens implantation and that have follow-up visits at Ophthalmology Service – Federal University of Uberlândia.Patients were eligible for participation if they met the following inclusion criteria: pseudophakia, uneventful cataract surgery, and visual acuity better than 20/40.

Exclusion criteria

Patients were excluded from the study if they had a prior history of uveitis or CME, substantial ocular irritation at baseline, or history of intraocular surgery or laser procedure within 4 months before baseline. We also excluded patients who had been treated with PG analogues in the past, and patients who had undergone other ocular surgery except for cataract. Finally, the presence of systemic disorders that could be associated with either uveitis or CME (i.e. diabetes, rheumatologic diseases), pregnancy, lactation or inadequate contraception (in females) were also exclusion criteria.

Outcome results