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The utility of the monocular trial: data from the ocular hypertension treatment study.

Abstract：

OBJECTIVE:To determine whether adjusting the intraocular pressure (IOP) change of the trial eye for the IOP change of the fellow eye (i.e., monocular trial) is a better assessment of medication response than testing each eye independently. DESIGN:Analysis of data from a prospective, randomized, clinical trial. PARTICIPANTS:Two hundred six participants with ocular hypertension randomized to the observation group and later started on a topical prostaglandin analog (PGA). METHODS:Participants were started on a topical PGA in 1 eye and returned in approximately 1 month to determine medication response. The IOP response of the trial eye was determined by the IOP change between baseline and 1 month in the trial eye alone (unadjusted method) and by adjusting for the IOP change in the fellow eye between the same visits (adjusted method). Our "gold standard" for medication response was the IOP change in the trial eye between up to 3 pre- and 3 posttreatment visits on the same medication. Pearson correlation was used to compare the gold standard with the unadjusted and adjusted methods. In addition, symmetry of IOP response between trial and fellow eyes to the same medication was determined by correlating the trial eye IOP change between up to 3 pre- and 3 posttreatment visits to the fellow eye IOP change between the same visits. MAIN OUTCOME MEASURES:Correlations of IOP change of the trial eye using the gold standard to the IOP change of the trial eye using the unadjusted and adjusted methods. RESULTS:The correlations of IOP change using the gold standard to the IOP change using the unadjusted and adjusted methods were r = 0.40 and r = 0.41, respectively. The correlation of IOP change of both eyes between the same pre- and posttreatment visits was r = 0.81. CONCLUSIONS:The monocular trial (i.e., adjusted method) appears equivalent to testing each eye independently (i.e., unadjusted method); however, neither method is adequate to determine medication response to topical PGAs. Both eyes have a similar IOP response to the same PGA. Further studies to understand IOP fluctuation are necessary to improve current methods of assessing medication response. FINANCIAL DISCLOSURE(S):Proprietary or commercial disclosure may be found after the references.

journal_name

Ophthalmology

journal_title

Ophthalmology

authors

Bhorade AM,Wilson BS,Gordon MO,Palmberg P,Weinreb RN,Miller E,Chang RT,Kass MA,Ocular Hypertension Treatment Study Group.

doi

10.1016/j.ophtha.2010.02.020

subject

Has Abstract

pub_date

2010-11-01 00:00:00

pages

2047-54

issue

eissn

0161-6420

issn

1549-4713

pii

S0161-6420(10)00184-3

journal_volume

117

pub_type

杂志文章,多中心研究,随机对照试验

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The utility of the monocular trial: data from the ocular hypertension treatment study.