Читать книгу Randomised Clinical Trials - David Machin - Страница 75

This is an open‐labelled, randomized, active‐controlled prospective pilot study comparing the efficacy of Brimonidine 0.2% with Timolol 0.5% as a neuroprotective agent in preventing/reducing visual field defects in patients with acute angle‐closure glaucoma (AACG). 80 patients presenting with AACG at 4 centes (SGH/SNEC, TTSH, NUH & CGH) will be recruited into the study and randomized to Timolol or Brimonidine, in addition to the standard medical treatment and laser peripheral iridotomy (PI) for AACG. Baseline Humphrey visual fields program 24–2 will be performed after PI. The study medication will be continued for 1 month and the visual fields compared at the end of 4 months to determine if either group has better preservation of fields. If Brimonidine is found to be efficacious in preserving visual fields and hence offering neuroprotection, a larger prospective randomized clinical trial may be planned subsequently to follow.

This statement was followed by a sentence describing the trial objectives, very brief eligibility requirements of ‘unilateral attack of AACG and informed consent’ only, and finally, a schema illustrating key aspects of the design to be implemented. The extract very clearly summarises the main features of the planned trial.

An abstract within a scientific journal would not normally contain a schema of the trial design due to space limitations. However, within a trial protocol, this may well be very helpful as an overview of the trial. Thus SQCP01 (2006) trial of Example 3.2 below has an initial Summary page (as opposed to designating this as an Abstract) containing a structured review of Objectives, Eligibility, Method, and Design including an outline schema of their factorial trial. A more detailed schema is given in a later section of their protocol.