Page 141 - DUOKOPT BIBLIOBOOK

EFFICACY

Acta Ophthalmologica 2010

the Glaucoma Hemifield Test (Asman 15.00 hours) and VF parameters. eye itself was avoided. Measurements
& Heijl 1992), exhibiting repeatable When the timolol run-in period was were taken using the conventional
abnormality at the p < 0.5% level by completed, patients returned to the technique (Lieb et al. 1991), which is
pattern deviation probability analysis, clinic for baseline measurements. identical to the technique we have
or by two or more locations in a clus- Baseline examination included mea- used in many previous studies (Marti-
ter exhibiting repeatable abnormality surements of blood pressure, heart nez et al. 1999; Martinez & Sanchez
at p < 2% by pattern deviation proba- rate, IOP in triplicate (at 09.00 hours, 2005, 2006, 2007, 2008a, 2008b,
bility analysis, excluding any location 12.00 hours and 15.00 hours), VF and 2008c). In brief, ophthalmic artery
in the cluster located in the opposite colour Doppler examinations. (OA) flow measurements were per-
horizontal hemifield. Early glaucoma Patients who met the IOP inclusion formed approximately 10–15 mm pos-
was defined according to the criteria requirements were randomly assigned, terior to the globe, where ultrasound
described by Hodapp et al. (1993), using a computer-generated randomi- signals are stronger. Short posterior
which require the mean deviation zation sequence, to receive either dor- ciliary artery (SPCA) images were
(MD) to be greater than – 6 dB, with zolamide 2% or brinzolamide 1%, taken temporally and nasally to the
< 18 points depressed below p < 0.05, each added to timolol maleate 0.5%, optic nerve just behind the posterior
< 10 points depressed below b.i.d. pole of the eye. The angle between
p < 0.001, and no point in the central Although central corneal thickness transducer and vessel orientation was
5 � with a sensitivity of < 15 dB. (CCT) measurements were not corrected. Central retinal artery
Patients with unreliable VF assess- included in the original protocol, they (CRA) measurements were taken at
ments (false negatives, false positives were obtained during the study in a the optic nerve head level.
or fixation losses > 20%) were large proportion of patients, compris- Peak systolic velocity (PSV) and
excluded. ing 88 eyes (61 patients) in the dorzo- end-diastolic velocity (EDV) were
Glaucomatous changes in the optic lamide–timolol (DT) group (89%), measured in the OA, CRA and medial
nerve head included either notching of and 102 eyes (64 patients) in the brin- and lateral SPCAs. Although the med-
the rim, diffuse emaciation of the rim zolamide–timolol (BT) group (88%). ial and lateral posterior ciliary arteries
area, a cup : disc ratio > 0.6, or Central corneal thickness was mea- (PCAs) were individually assessed, the
asymmetry of the cup : disc ratio sured using an ultrasonic pachymeter mean value of both was used for the
> 0.2 (Dong & Chihara 2001). (Corneo-Gage Plus 2; Sonogage Inc., statistical analysis.
Cleveland, OH, USA). Peak systolic velocity and EDV
Follow-up visits were scheduled were used to calculate the Pourcelot
Patient visits
every 6 months, and included a review resistivity index (RI) using the follow-
The protocol included one screening of the medical history, BCVA, ing equation: RI = PSV ) EDV⁄ PSV
visit, one post-screening visit, and one slit-lamp examination of the anterior (Pourcelot 1975).
baseline visit. At the screening visit, segment with dilated pupils, IOP mea- Blood pressure and radial pulse
each subject underwent a standard surement in triplicate (at 09.00 hours, were measured after a 10-min rest in a
ophthalmic examination, including a 12.00 hours and 15.00 hours), gonios- sitting position. Systolic (SBP) and
review of medical history, best cor- copy, dilated funduscopic examination diastolic blood pressures (DBP) were
rected visual acuity (BCVA), slit-lamp using a 78-D lens, stereoscopic optic measured in the upper right arm using
examination of the anterior segment disc photography, automated perime- a mercury sphygmomanometer, and
with dilated pupils, IOP measurement try, blood pressure, heart rate heart rate (HR) was measured by pal-
in triplicate (at 09.00 hours, and colour Doppler examinations (at pation of radial pulse. These parame-
12.00 hours and 15.00 hours) using 09.00 hours). Study measurements ters were assessed every 10 mins
Goldmann applanation tonometry were performed within ± 1 hour of during Doppler examination. Mean
(Goldmann tonometer; Haag Streit the stated times. arterial pressure (MAP) was calcu-
AG, Koeniz, Switzerland), gonios- Follow-up visits included an assess- lated as: DBP + 1 ⁄3 (SBP)DBP).
copy, dilated funduscopic examination ment of compliance and monitoring Ocular perfusion pressure (OPP)
using a 78-D lens, stereoscopic optic for potential side-effects and adverse was calculated as: 2⁄ 3 (MAP)IOP).
disc photography, and automated effects.
perimetry using the 24-2 full-threshold Compliance data were collected Analyses of visual field defect progression
strategy on the Humphrey VF analy- using a standardized questionnaire.
ser (Carl Zeiss Meditec, Dublin, CA, Time to VF defect progression was
USA). A detailed medical history was Colour Doppler imaging defined as the time from confirmation
obtained, paying special attention to of a VF defect to progression.
vascular disease. All colour Doppler imaging (CDI)
Potentially eligible patients started a examinations (model SSA-340; Toshi-
4-week run-in period during which ba Medical Systems, Tustin, CA, Event analyses of pattern deviation
probability maps
timolol maleate 0.5% was adminis- USA) were performed at all study vis-
tered (one drop in each eye b.i.d.). its by the same experienced observer Event analyses of VF defect progres-
The post-screening examination (blinded to the treatment). sion were performed by a point-by-
included measurements of blood pres- A 7.5-MHz vector-array transducer point comparison between the baseline
sure, heart rate, IOP in triplicate was applied to the closed eyelid using deviation, calculated as the mean
(at 09.00 hours, 12.00 hours and a coupling gel; any pressure on the value in the first three examinations

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